Clinically confirmed as postmenopausal.
Participants must be fully postmenopausal
Postmenopausal status, defined as no menstrual cycle for 12 months or surgical removal of ovaries
A woman is considered to be of childbearing potential if she is not postmenopausal, has not reached a postmenopausal state (? 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
Only females are eligible. Menopausal status: i. Postmenopausal defined by:
Female participants must be either postmenopausal defined as:
Patients can be premenopausal or postmenopausal
Female participants must be either postmenopausal defined as:
Postmenopausal women\r\n* Postmenopausal if satisfies one or more of the following criteria: age greater than 52 years of age; having had a bilateral oophorectomy; amenorrhoeic for at least 12 months
Postmenopausal woman
Postmenopausal defined as:
For Part 1, postmenopausal women only
Patient is postmenopausal woman defined as either:
Be postmenopausal (defined as amenorrheic for at least 12 months)
have postmenopausal status
If female, patient is postmenopausal
Postmenopausal women. Postmenopausal status is defined by the National Comprehensive Cancer Network as either:
Postmenopausal status as defined by the protocol
Postmenopausal women. Postmenopausal status is defined either by:
Postmenopausal women
Patient is postmenopausal
Have postmenopausal status
Postmenopausal status
Postmenopausal women
Subject is considered postmenopausal
Men and pre- and postmenopausal women are eligible
Patient is postmenopausal. Postmenopausal status is defined either by:
Postmenopausal women
Postmenopausal
In premenopausal women, serum estradiol level in postmenopausal range =< 7 days prior to registration
Patient is postmenopausal.
Premenopausal or postmenopausal women
Have postmenopausal status.
Postmenopausal status
Postmenopausal status.
Postmenopausal for at least 1 year OR
Must be female and postmenopausal.
Postmenopausal women
Postmenopausal women
Have been postmenopausal for ?1 year
Postmenopausal women, defined by lack of a menstrual period for an entire year
All women will be postmenopausal, defined as having follicle-stimulating hormone (FSH) and estradiol within the institutional postmenopausal range at the time of study entry and no menstrual cycle in the last 12 months
Women who are postmenopausal by surgery, radiotherapy, or presence of natural amenorrhea >= 12 months
Postmenopausal women are defined as those with their last menstrual period more than 12 months prior to study entry; for the purpose of defining menopausal status for women who have had surgical cessation of their periods, women who no longer have menses due to hysterectomy and oophorectomy will be considered postmenopausal; women who no longer have menses due to hysterectomy without oophorectomy will be considered premenopausal until age 52 and postmenopausal thereafter
All other postmenopausal women are eligible for inclusion in the biennial screening regimen
Postmenopausal women (defined per provider discretion and notated in the medical record)
The study will be conducted in postmenopausal women
Postmenopausal women
Postmenopausal women. Postmenopausal status is defined either by:
Postmenopausal (no menstrual cycle in the past 12 months)
Participant must be a non-Hispanic white or non-Hispanic black (self-reported race) woman 45 to 80 years of age and postmenopausal; postmenopausal will be defined as no menstrual cycle in the past 12 months; women with a hysterectomy but with intact ovaries will be included if aged >= 55 years
Postmenopausal women defined as women with:
Women must be postmenopausal (defined as no menstrual cycle for 12 months or surgical history of bilateral salpingoopherectomy); postmenopausal women of all races and ethnic groups are eligible to participate for this trial; men are not eligible\r\n* Note: women who have had a hysterectomy without a bilateral salpingoopherectomy may still be pre-menopausal; confirmation of postmenopausal status is required for these patients and will be measured by testing levels of estradiol, progesterone and follicle stimulating hormone (FSH) (lab ranges per institutional standards); in addition, confirmation of postmenopausal status may be performed in any patient with unclear menopausal status per treating physician discretion
Postmenopausal, verified by: \r\n* Post bilateral surgical oophorectomy, or\r\n* No spontaneous menses >= 1 year or\r\n* No menses for < 1 year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
Post-menopausal defined as the absence of menses for at least one year (serum FSH ?20IU/L can also be measured according to local practice), OR
postmenopausal (defined as at least 1 year without menses) prior to screening or
INCLUSION - ENROLLMENT: Only postmenopausal women will be eligible. Subjects will be classified as being postmenopausal if they have had:\r\n* No spontaneous menses > 1 year, or\r\n* Bilateral surgical oophorectomy, or\r\n* No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
Postmenopausal with last natural menses > 24 months prior
Postmenopausal or premenopausal; \r\n* NOTE: Postmenopausal women, verified by: \r\n** Bilateral surgical oophorectomy, or \r\n** No spontaneous menses >= 1 year or \r\n** No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards; \r\n* Premenopausal women, verified by: \r\n** Regular menses, or \r\n** FSH and estradiol levels in premenopausal range, according to institutional standards
postmenopausal (defined as at least 1 year without any menses for which there is no other obvious pathological or physiological cause) prior to Screening, or
Patients may be premenopausal or postmenopausal at the time of randomization; for study purposes, postmenopausal is defined as:\r\n* Age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or\r\n* Age 55 or younger with no spontaneous menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or\r\n* Documented bilateral oophorectomy
post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
Sexually active female patients of childbearing potential and sexually active male patients must agree to use an effective method of birth control (e.g., barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study and for 4 months after final administration of study drug. Note that sterility in female patients must be confirmed in the patients' medical records and be defined as any of the following: surgical hysterectomy with bilateral oophorectomy, bilateral tubular ligation, natural menopause with last menses >1 year ago; radiation induced oophorectomy with last menses >1 year ago; chemotherapy induced menopause with last menses >1 year ago.
Be of non-childbearing potential: post-menopausal (defined as at least 1 year without any menses) prior to Screening, or documented surgically sterile or post-hysterectomy (at least 1 month prior to Screening)
Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
Only postmenopausal women will be eligible; subjects will be classified as being postmenopausal if they have had:\r\n* Bilateral surgical oophorectomy, or\r\n* No spontaneous menses > 1 year or\r\n* No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
Not of childbearing potential: postmenopausal (defined as no spontaneous menses for at least 12 consecutive months prior to Screening with follicle-stimulating hormone [FSH] > 40 IU/L for women < 55 years of age at Screening), or documented to be surgically sterile or status posthysterectomy (at least 1 month prior to Screening).
Patients must be postmenopausal women defined as: Age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or Age 55 or younger with no menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or Age greater than or equal to 18 with documented bilateral oophorectomy.
Postmenopausal defined as no menses for 12 or more months without an alternative medical cause OR
Post-menopausal women, as verified by:\r\n* Post bilateral surgical oophorectomy, or\r\n* No spontaneous menses >= 1 year, or\r\n* No menses for < 1 year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
Postmenopausal women; women are eligible if they are postmenopausal (older than 50 years of age with no spontaneous menses for at least 12 months; or 50 years of age or younger either with no spontaneous menses [amenorrheic] within 12 months of randomization [e.g., spontaneous or secondary to hysterectomy] and a follicle-stimulating hormone level within the postmenopausal range or with prior bilateral oophorectomy)
Premenopausal levels of estradiol, or ongoing menses
of non-childbearing potential (i.e., women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); or
Be of nonchildbearing potential: postmenopausal (defined as at least 1 year without any menses) prior to Screening, or documented surgically sterile
Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
Patient is postmenopausal or premenopausal\r\n* NOTE: postmenopausal women, verified by\r\n** Bilateral surgical oophorectomy, or\r\n** No spontaneous menses >= 1 year or\r\n** No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards or\r\n* Premenopausal women, verified by:\r\n** Regular menses or\r\n** FSH and estradiol levels in premenopausal range, according to institutional standards
Age >= 50 years and postmenopausal with no menses for at least one year prior to study enrollment
Be of nonchildbearing potential: postmenopausal (defined as at least 1 year without any menses) prior to screening, or documented surgically sterile
post-menopausal (defined as at least 1 year without any menses) prior to Screening,
Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
Postmenopausal women defined by either: natural menopause with at least one year since last menses, or chemotherapy-induced menopause with at least one year since last menses and follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal range
Eligible women are those who:\r\n* Are post-menopausal, verified by:\r\n** Post bilateral surgical oophorectomy; or\r\n** No spontaneous menses >= 1 year; or\r\n** No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
Natural menopause with last menses >1 year ago
Radiation induced oophorectomy with last menses >1 year ago
Chemotherapy induced menopause with last menses >1 year ago
Postmenopausal women, defined as:\r\n* Age > 45 with no menses for at least 2 years
Menopause as defined as no menses for 1 year and/or follicle-stimulating hormone (FSH) >= 25.8 mIU/ml
confirming the subject is post menopausal, with a minimum 1 year without menses
Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
Patient is postmenopausal\r\nFor study purposes, postmenopausal is defined as:\r\n* Age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or\r\n* Age 55 or younger with no spontaneous menses for at least 12 months prior to study entry (e.g. spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or\r\n* Documented bilateral oophorectomy
Use of other investigational agents from 30 days prior to the Screening Visit through discontinuation of study drug.
Subjects with primary liver cancer or hepatic metastasis are eligible to enroll, provided that, at the Screening Visit, the following criteria are met:
documented as surgically sterilized (at least 1 month prior to the screening visit)
Are postmenopausal for at least 1 year before the screening visit, OR
Platelets >= 75 x 10^9/L, at the screening visit
Are postmenopausal for at least 1 year before the screening visit, OR
Creatinine (Cr) > 2 mg/dL at the screening visit
Hemoglobin < 9 g/dL at the screening visit at the screening visit
Creatinine (Cr) > 2 mg/dL at the screening visit
Withdrawal from the OPN-305-106 study prior to the final EOT visit
Subjects with a platelet count of at least 100 x 10^9 at the screening visit
Are postmenopausal for at least 1 year before the screening visit, OR
Age ?18 years at the screening visit.
Subjects with clinically apparent arrhythmia, or arrhythmias that are not stable on medical management within 2 weeks of the screening/enrollment visit
Are postmenopausal for at least 1 year before the screening visit, or
Are at least age 18 at screening (Visit 1)
Locoregional treatment within 4 weeks prior to the Baseline Visit.
INCLUSION CRITERIA\n\n          1. Patient is ambulatory male or female 16 to 70 years of age at the Screening Visit.\n\n          2. Patient has SCD, including HbSS, HbSC, HbS?0-thalassemia, or HbS?+-thalassemia,\n             documented in their medical history.\n\n          3. If patient is on medication(s) for SCD, such as hydroxyurea (HU), are on a stable\n             regimen.\n\n          4. Per medical history and/or patient recall, patient has had at least 1 and no more than\n             10 sickle cell-related pain crises in the 12 months before the Screening Visit and\n             none occurring in the 4 weeks before the Randomization Visit.\n\n          5. Patient completes daily eDiary entries for at least 10 days during the last 14 days of\n             the Run in Period as assessed at the Randomization Visit.\n\n          6. Women of childbearing potential must have a negative pregnancy test prior to\n             randomization and must agree to use protocol-specified contraception from the\n             Screening Visit through 90 days after the final dose of study drug.\n\n          7. Male patients must be surgically sterile by vasectomy (conducted ?60 days before the\n             Screening Visit or confirmed via sperm analysis) or must agree to use\n             protocol-specified contraception and agree to refrain from sperm donation from the\n             Screening Visit through 90 days after the final dose of study drug.\n\n        EXCLUSION CRITERIA\n\n          1. Patient requires a program of prescheduled, regularly administered chronic blood\n             transfusion therapy.\n\n          2. Patient has been hospitalized for an SCD-related complication in the 4 weeks before\n             the Randomization Visit.\n\n          3. Patient has taken opioid(s) >200 morphine mg equivalent/day within the 4 weeks before\n             the Randomization Visit.\n\n          4. Patient is taking aspirin ?325 mg daily, P2Y12 inhibitors, any anticoagulant\n             medication, specific inhibitors of phosphodiesterase 5 (PDE5), nonspecific inhibitors\n             of PDE5, moderate or strong cytochrome P450 3A (CYP3A) inhibitors, any supplements for\n             the treatment of erectile dysfunction, riociguat, or nitrates or nitric oxide donors\n             in any form.\n\n          5. Patient has major concurrent illness or medical condition that in the opinion of the\n             Investigator would preclude participation in a clinical study.\n\n        NOTE: Other inclusion and exclusion criteria apply, per protocol
Age ?18 years at the screening visit.
Haematologic and biochemical indices within the ranges shown below at the screening visit
Good health with adequate hematologic, renal, hepatic, and cardiac function, as determined by the Investigator, based upon medical history, physical examination, and laboratory test results at the screening visit (Visit 1):
Group 3 - patients must have pathologically documented, definitively diagnosed advanced MTC that has progressed within 14 months prior to the Screening Visit.
Hemoglobin level at least 6.5 g/dL at Screening visit
Any prostate related investigational therapy within 6 months of Visit 1
Cryoablation should be performed within 14 days of screening visit
Prior radiation therapy of the index tumor <3 weeks prior to the screening visit
Are postmenopausal for at least 1 year before the screening visit, OR
Are postmenopausal for at least 1 year before the Screening visit , or
Exposure to other investigational products within 28 days prior to Screening Visit
Uncontrolled angina within 6 months before the Day 1 visit.
Subject has used any of the following within 28 days before the Day 1 visit:
Use of an investigational agent within 4 weeks before the screening visit;
Prior systemic treatment with an azole drug within four weeks of screening visit
Thromboembolism within 6 months of screening visit
Major surgery or radiation therapy within 30 days of screening visit
Are postmenopausal for at least 1 year before the screening visit, OR
Phase 1b subject has a positive drug or alcohol urine test at screening visit.
Are postmenopausal for at least 1 year before the screening visit, OR
Treatment with a systemic investigational agent within 28 days before the screening visit.
Were postmenopausal for at least 24 months before the screening visit, OR
The patient has pathologically documented AML and is in CR1 at the time of the screening visit
The patient achieved CR1 within 10 weeks of the screening visit; the patient may have received post-remission consolidation therapy (except for transplant) prior to the screening visit
The patient has not received an investigational chemotherapy within the last 28 days prior to the screening visit and has never received investigational immunotherapy. In addition, the patient must not receive treatment for AML (including treatment with IL-2 or IFN?) in the interval of time between the screening visit and initiation of pre-infusion preparative therapy
Subject has positive test result at the screening visit for one or more of the following:
Ability to adhere to dose and visit schedules.
Progression should have occurred within the immediate prior 2 months of the time of screening visit, with no intervening anti-cancer therapy
The presence of TAM as per below diagnostic criteria at baseline (or screening if baseline visit is skipped). All the criteria have to be met for the patients included in the study:
Any active, severe local or systemic infection at the screening visit
All subjects must be >/= 18 years at the first screening examination / visit
Active bleeding within 4 weeks prior to screening visit
Are postmenopausal for at least 1 year before the screening visit, OR
Are postmenopausal for at least 1 year before the screening visit, OR
Subjects taking immunosuppressive medications at the screening visit
Received AT treatment within the last 3 months prior to Screening visit.
Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments.
Are post-menopausal for at least 1 year before the screening visit, OR
Are postmenopausal for at least 1 year before the screening visit, OR
Any active, severe local or systemic infection at the screening visit
Undergone a therapeutic surgical procedure within 30 days from the screening visit.
Uncontrolled angina within 3 months of Screening visit;
History of GI bleeding within 6 months of Screening visit
All subjects must be ? 18 years at the first screening examination / visit
Other investigational therapy received within 8 weeks prior to screening visit
Are postmenopausal for at least 1 year before the screening visit, or
Have a documented visit with an oncologist during the previous 6-months
Participated in an investigational study for radiation dermatitis within 3 months of the screening visit
Severe illness at the time of the clinic visit
Subjects with a platelet count of at least 75 x 10^9/L at the screening visit
Other (non-cancer) disease not stabilized within 1 month before the Screening Visit
Screening visit 2 must occur within 8 weeks prior to administration of the first dose of Polyphenon E
Positive urine drug test at screening visit
History of 3 or more biopsy confirmed BCCs in the preceding 2 years, calculated from 2 years prior to the screening visit; the number of BCCs found at the screening visit will not be included in the number of BCCs that qualify the subject for the study; if the subject after signing the consent form is found to not have had 3 BCCs prior to the screening visit then they will be a screen failure and will not enter the study
Subjects taking immunosuppressive medications at the screening visit (day 0)
Year 3 visit can not exceed 3 years and 6 months from the baseline visit
Subjects agree to be contacted 4-6 weeks after each study visit
Known pregnancy at study Visit 1.
Presenting for colposcopy at study Visit 1.
Total bilirubin within the normal range at the screening visit
Creatinine < (1.5 mg/dL) at the screening visit
Albumin > 30 g/L (3.0 g/dL) at the screening visit
Any Parkland outpatient visit during study period
Patients must have been seen for a visit for cancer surveillance between 2009 and 2013
Are postmenopausal for at least 1 year before the Screening visit, or
Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40pg/mL (< 140 pmol/L)
Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT
Individuals of non-childbearing potential, or individual of childbearing potential with negative serum pregnancy test =< 7 days prior to randomization and willing to practice total abstinence or use a highly effective method of contraception, as outlined below:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female individual who has had the following:\r\n** A hysterectomy\r\n** A bilateral oophorectomy (ovariectomy)\r\n** A bilateral tubal ligation\r\n** Is post-menopausal\r\n** NOTE: Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L); subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any individual who has had a negative serum pregnancy test, =< 7 days prior to randomization\r\n* Agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product\r\n** Oral contraceptive, either combined or progestogen alone\r\n** Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year\r\n** Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases, a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 milli-International units per milliliter and estradiol < 40 picograms per milliliter (< 140 picomole per liter) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods defined in protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least two to four weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; Child-bearing potential and agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until at least 7 months after the last dose of study medication; Negative serum pregnancy test <= 7 days prior to first study drug dose; Female subjects who are lactating must discontinue nursing prior to the first dose of study treatment and must refrain from nursing throughout the treatment period and for 5 half-lives of GSK525762 or at least 28 days (whichever is longer) following the last dose of study treatment.
Women are eligible to participate if: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/mL and estradiol < 40 pg/mL (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
Female patients who have been on hormone replacement therapy (HRT) for menopausal symptoms for a period of at least 2 months will not be excluded from the study provided the HRT regimen remains unchanged during the conduct of the study.
Female subjects are eligible to enter the study if they are either:\r\n* Of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any woman who:\r\n** Has had a hysterectomy, or\r\n** Has had a bilateral oophorectomy, or\r\n** Has had a bilateral tubal ligation, or\r\n** Is post-menopausal (demonstrates total cessation of menses for greater than or equal to 1 year) OR\r\n* Of childbearing potential, has a negative serum pregnancy test at screening, and agrees to one of the following contraceptives:\r\n** An intrauterine device (IUD) with a documented failure rate of less than 1% per year\r\n** Vasectomized partner who is sterile prior to the subject’s entry and is the sole sexual partner for that woman\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, during the clinical trial, and for at least 14 days after the last dose of investigational product\r\n** Double barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; OR diaphragm with spermicide; OR male condom and diaphragm
Women of childbearing potential must have a negative B-Human chorionic gonadotropin (HCG) documented within 7 days prior to registration and must agree to practice adequate contraception as defined below. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), includes any female who has had:\r\n* A hysterectomy\r\n* A bilateral oophorectomy\r\n* A bilateral tubal ligation\r\n* Is post-menopausal: Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L).
Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT.
Reproductive criteria: 1. A male subject with female partner of child bearing potential must agree to use one of the methods of contraception for the duration specified in protocol. 2. A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test), not nursing, and at least one of the following conditions apply: Reproductive potential: subject must agree to follow one of the options and the duration specified in protocol; Non-reproductive potential defined as i) Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy; ii) Postmenopausal defined as 12 months of spontaneous amenorrhea with an appropriate clinical profile or females over 60 years of age. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
A female subject is eligible to participate if she is of: a) non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] > 40 MlU/mL and estradiol < 40 pg/mL [< 140 pmol/L] is confirmatory); females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods listed below if they wish to continue their HRT during the study; otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment; for most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT; following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; b) child-bearing potential and agrees to use one of the contraception methods listed below for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point; female subjects must agree to use contraception until 4 weeks after the last dose of study medication, and must have a negative serum or urine pregnancy test within 14 days prior to the start of dosing
Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L)
Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT
Male and female. Males: Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication for a cycle of spermatogenesis following five terminal half-lives after the last dose of study medication. Vasectomy with documentation of azoospermia. Male condom plus partner use of one of the contraceptive options below: Contraceptive subdermal implant, Intrauterine device or intrauterine system, Combined Oral Contraceptive or Injectable progestogen, Contraceptive vaginal ring, Percutaneous contraceptive patches . This is an all-inclusive list of those methods that meet the following GlaxoSmithKline (GSK) definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (e.g., male sterility), the investigator determines what is consistent and correct use. The GSK definition is based on the definition provided by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. Females A female subject is eligible to participate if she is not pregnant (as confirmed by a negative Urine human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: • Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy. Postmenopausal defined as: 60 years old; Twelve(12) months of spontaneous amenorrhea with an appropriate clinical profile, e.g. age appropriate, > 45 years, in the absence of hormone replacement therapy (HRT) or medical suppression of the menstrual cycle (e.g. leuprolide treatment) in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and oestradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels). Females on HRT and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. • Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) (As mentioned in study protocol) from 30 days prior to the first dose of study medication and until 3 months after the last dose of study medication. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception
A female is eligible to enter and participate in this study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:\r\n** A hysterectomy\r\n** A bilateral oophorectomy (ovariectomy)\r\n** A bilateral tubal ligation\r\n** Is post-menopausal\r\n** Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L)\r\n** Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any female who has had a negative serum pregnancy test, =< 7 days prior to registration\r\n* Agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product\r\n** Oral contraceptive, either combined or progesterone alone\r\n** Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year\r\n** Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 milli international unit/mL and estradiol less than 40 pg/mL (less than 140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; Child-bearing potential and agrees to use one of the contraception methods (described in the protocol) for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 7 months after the last dose of study medication; Negative serum pregnancy test <=7 days prior to first study drug dose; Female subjects who are lactating must discontinue nursing prior to the first dose of study treatment and must refrain from nursing throughout the treatment period and for 5 half-lives of GSK525762 or at least 28 days (whichever is longer) following the last dose of study treatment.
A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, hysterectomy, or documented bilateral tubal oophorectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 units (U)/mL and estradiol <40 picograms (pg)/mL (<140 picomoles (pmol)/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. Child-bearing potential and agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 7 months after the last dose of study medication. Negative serum pregnancy test <=7 days prior to first study drug dose. Female subjects who are lactating must discontinue nursing prior to the first dose of study treatment and must refrain from nursing throughout the treatment period and for 5 half-lives of GSK2820151 or at least 28 days (whichever is longer) following the last dose of study treatment.
Women are eligible to participate if: non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] > 40 MlU/mL and estradiol < 40 pg/mL [< 140 pmol/L] is confirmatory); females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study; otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment; for most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT
A female is eligible to enter and participate in this study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:\r\n** A hysterectomy\r\n** A bilateral oophorectomy (ovariectomy)\r\n** A bilateral tubal ligation\r\n** Is post-menopausal:\r\n*** Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L)\r\n*** Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; Novartis acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product; oral contraceptive, either combined or progestogen alone\r\n** Injectable progestogen\r\n** Implants of levonorgestrel\r\n** Estrogenic vaginal ring\r\n** Percutaneous contraceptive patches\r\n** Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year\r\n** Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)\r\n* Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
A female is eligible to enter and participate in this study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had: \r\n** A hysterectomy\r\n** A bilateral oophorectomy (ovariectomy)\r\n** A bilateral tubal ligation \r\n** Is post-menopausal\r\n*** Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L)\r\n*** Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within 7 days of registration, and agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product\r\n** Oral contraceptive, either combined or progestogen alone\r\n** Injectable progestogen\r\n** Implants of levonorgestrel\r\n** Estrogenic vaginal ring \r\n** Percutaneous contraceptive patches \r\n** Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year\r\n** Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
A female is eligible to enter and participate in this study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:\r\n** A hysterectomy\r\n** A bilateral oophorectomy (ovariectomy)\r\n** A bilateral tubal ligation\r\n** Is post-menopausal\r\n** Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L); subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; Novartis Pharmaceuticals acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product \r\n** Oral contraceptive, either combined or progestogen alone\r\n** Injectable progestogen\r\n** Estrogenic vaginal ring\r\n** Percutaneous contraceptive patches\r\n** Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year\r\n** Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository); female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
A female is eligible to enter and participate in this study if she is of: non-childbearing potential including \r\n* Any female who has had a surgical procedure rendering her incapable of becoming pregnant\r\n* Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L)\r\n* Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT; childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception GlaxoSmithKline (GSK) acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows: \r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product\r\n** Oral contraceptive \r\n** Injectable progestogen\r\n** Implants of levonorgestrel\r\n** Estrogenic vaginal ring \r\n** Percutaneous contraceptive patches \r\n** Intrauterine device (IUD) \r\n** Male partner sterilization\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository); female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
A female patient is eligible to enter and participate in the study if she is:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any woman who:\r\n ** Has had a hysterectomy, or\r\n ** Has had a bilateral oophorectomy (ovariectomy), or\r\n ** Has had a bilateral tubal ligation, or\r\n ** Is post-menopausal\r\n*** Patients not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L)\r\n*** Patients using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any female who has a negative serum or urine pregnancy test within 14 days prior to the first dose of study treatment and agrees to one of the following:\r\n ** An intrauterine device with a documented failure rate of less than 1% per year.\r\n ** Vasectomized partner who is sterile prior to the patient’s entry and is the sole sexual partner for that woman.\r\n ** Complete abstinence from sexual intercourse for 14 days before exposure to investigation product, throughout the clinical trial, and for at least 21 days after the last dose of investigational product.\r\n ** Double barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; or diaphragm with spermicide; or male condom and diaphragm.\r\n ** Oral contraceptive, either combined or progestogen alone\r\n ** Injectable progestogen\r\n ** Implants of levonorgestrel\r\n ** Estrogenic vaginal ring\r\n ** Percutaneous contraceptive patches
A female is eligible to enter and participate in this study if she is of: \r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had: \r\n** A hysterectomy \r\n** A bilateral oophorectomy (ovariectomy) \r\n** A bilateral tubal ligation, or \r\n** Is post-menopausal \r\n* Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L) \r\n* Subjects must discontinue HRT prior to study enrollment due to the potential for inhibition of cytochrome P450 (CYP) enzymes that metabolize estrogens and progestins; for most forms of HRT, at least 2-4 weeks must elapse between the cessation of HRT and determination of menopausal status; length of this interval depends on the type and dosage of HRT; if a female subject is determined not to be postmenopausal, they must use adequate contraception as defined immediately below during the trial and for 8 weeks after the last dose \r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows: an intrauterine device with a documented failure rate of less than 1% per year, vasectomized partner who is sterile prior to the female subject’s entry and is the sole sexual partner for that female, double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide); Note: Oral contraceptives are not reliable \r\n* Female subjects who are lactating should not be in the trial\r\n* A male with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study
EXPANSION COHORT ONLY: A female is eligible to enter and participate in this study if she is of: \r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had: \r\n** A hysterectomy \r\n** A bilateral oophorectomy (ovariectomy) \r\n** A bilateral tubal ligation, or \r\n** Is post-menopausal \r\n* Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40  pg/mL (< 140 pmol/L) \r\n* Subjects must discontinue HRT prior to study enrollment due to the potential for inhibition of cytochrome P450 (CYP) enzymes that metabolize estrogens and progestins; for most forms of HRT, at least 2-4 weeks must elapse between the cessation of HRT and determination of menopausal status; length of this interval depends on the type and dosage of HRT; if a female subject is determined not to be postmenopausal, they must use adequate contraception as defined immediately below during the trial and for 8 weeks after the last dose \r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows: an intrauterine device with a documented failure rate of less than 1% per year, vasectomized partner who is sterile prior to the female subject’s entry and is the sole sexual partner for that female, double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide); Note: Oral contraceptives are not reliable \r\n* Female subjects who are lactating not be included in the trial \r\n* A male with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study
Female subjects are eligible to enter the study if they are either:\r\n* Of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any woman who:\r\n** Has had a hysterectomy, or\r\n** Has had a bilateral oophorectomy (ovariectomy), or\r\n** Has had a bilateral tubal ligation, or\r\n** Is post-menopausal (demonstrates total cessation of menses for greater than or equal to 1 year)\r\nOR\r\n* Of childbearing potential, has a negative serum pregnancy test at screening, and agrees to one of the following contraceptives\r\n** An intrauterine device (IUD) with a documented failure rate of less than 1% per year\r\n** Vasectomized partner who is sterile prior to the subject’s entry and is the sole sexual partner for that woman\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, during the clinical trial, and for at least 14 days after the last dose of investigational product\r\n** Double barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; OR diaphragm with spermicide; OR male condom and diaphragm
Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L); subjects must discontinue HRT prior to study enrollment; for most forms of HRT, at least 2-4 weeks must elapse between the cessation of HRT and determination of menopausal status; length of this interval depends on the type and dosage of HRT; if a female subject is determined not to be post-menopausal, they must use adequate contraception
Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods stated in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least two to four weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
Females are eligible to enter and participate in this study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:\r\n** A hysterectomy\r\n** A bilateral oophorectomy (ovariectomy)\r\n** A bilateral tubal ligation\r\n** Is post-menopausal\r\n** Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40pg/mL (< 140 pmol/L)\r\n** Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; GlaxoSmithKline (GSK) acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:\r\n** An intrauterine device with a documented failure rate of less than 1% per year \r\n** Vasectomized partner who is sterile prior to the female subject’s entry and is the sole sexual partner for that female\r\n** Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product\r\n** Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide)\r\n** Oral contraceptives