[c09aa8]: / clusters / 9knumclustersv2 / clust_1472.txt

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Women of child-bearing potential (WOCBP) comprises women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal (see definition below)\r\n* Post-menopause is defined as:\r\n** Women who have had amenorrhea for >= consecutive months (without another cause) and who have a documented serum follicle stimulating hormone (FSH) level > mIU/mL\r\n** Women who have irregular menstrual periods and a documented serum FSH level > mIU/mL\r\n** Women who are taking hormone replacement therapy (HRT)
Females of childbearing potential and their male partners are advised to practice a highly effective method of contraception during treatment with rucaparib and for month following the last dose for females and months following the last dose for males; a woman is considered to be of childbearing potential unless one of the following applies:\r\n* Is considered to be permanently sterile; permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy\r\n* Is postmenopausal, defined as no menses for months without an alternative medical cause; a high follicle-stimulating hormone (FSH) level consistently in the postmenopausal range ( mIU/mL or higher) may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of months of amenorrhea, a single FSH measurement is insufficient to confirm a postmenopausal state\r\n* Highly effective contraception is considered to be a method with a < % per year failure rate; recommendations for highly effective contraception while taking rucaparib include:\r\n** Ongoing use of injectable or implantable progesterone\r\n** Placement of an intrauterine device or intrauterine system\r\n** Bilateral tubal occlusion\r\n** Complete (as opposed to periodic) abstinence\r\n** Male sterilization, with appropriate post-vasectomy documentation of absence of sperm in ejaculate
WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), and who is not postmenopausal; post menopause is defined as:\r\n* Amenorrhea >= consecutive months without another cause, and a documented serum follicle stimulating hormone (FSH) level > mIU/mL or\r\n* Women with irregular menstrual periods and a documented serum follicle stimulating hormone (FSH) level > mIU/mL or NOTE: FSH level testing is not required for women >= years old with amenorrhea of >= year\r\n* Women on hormone replacement therapy (HRT)
For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > mIU/mL
Pregnancy or lactation period; note: a negative pregnancy test is required for women of childbearing potential; women who are postmenopausal (age-related amenorrhea >= consecutive months or follicle-stimulating hormone [FSH] > milli international units per milliliter [mIU/ml]), or who had undergone hysterectomy or bilateral oophorectomy are exempt from pregnancy testing; if necessary to confirm postmenopausal status a FSH level will be included at screening; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with avelumab; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with avelumab
Women who are pregnant or lactating. NOTE: Women of childbearing potential (WOCBP) must have a \negative\ serum pregnancy test within one week prior to treatment. a) Women not OCBP defined as any of the following: i) Postmenopausal with > year since last menses and: () If younger than years old, with a follicle-stimulating hormone (FSH) > mIU/mL () If older than years old and not on hormone replacement therapy (HRT), with a FSH > mIU/mL () If older than years old and on HRT, the FSH requirement in not applicable. Postmenopausal females on HRT will be allowed if the treatment is stable for at least months prior to dosing of study drug(s) () Written medical documentation of being sterilized (e.g. hysterectomy, double oophorectomy, bilateral salpingectomy) with the procedure performed at least months prior to dosing study drug(s). Note: Tubal ligation is not considered a form of permanent sterilization () Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Negative serum or urine pregnancy test done =< days prior to registration and repeated prior to dosing on day of each cycle, for individuals of childbearing potential only; NOTE: Individuals are considered to be of childbearing potential unless one of the following applies:\r\n* Is postmenopausal, defined as no menses for at least months without an alternative medical cause; a high follicle-stimulating hormone (FSH) level consistently in the postmenopausal range ( mIU/mL or higher) may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of months of amenorrhea, a single FSH measurement is insufficient to confirm a postmenopausal state: or\r\n* Considered to be permanently sterile; permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy
For female subjects to be considered as not having childbearing potential, they must meet or more of the following criteria: \r\n* Postmenopausal for at least consecutive months; \r\n* Surgically sterile (ie, have had a hysterectomy or bilateral oophorectomy); \t\r\n* Females with irregular menstrual periods and/or on hormone replacement therapy must have a documented serum follicle stimulating hormone level > mIU/mL
For female subjects to be considered as not having childbearing potential, they must meet or more of the following criteria: \r\n* Postmenopausal for at least consecutive months\r\n* Surgically sterile (ie, have had a hysterectomy or bilateral oophorectomy) \r\n* Females with irregular menstrual periods and/or on hormone replacement therapy must have a documented serum follicle stimulating hormone level > mIU/mL
For female subjects to be considered as not having childbearing potential, they must meet or more of the following criteria:\r\n* Postmenopausal for at least consecutive months\r\n* Surgically sterile (ie, have had a hysterectomy or bilateral oophorectomy)\r\n* Females with irregular menstrual periods and/or on hormone replacement therapy must have a documented serum follicle stimulating hormone level > mIU/mL
Women of non-childbearing potential may be included if they are either surgically sterile or considered postmenopausal; women who have documentation of at least months of spontaneous amenorrhea and have an follicle stimulating hormone (FSH) level > mIU/mL will be considered postmenopausal
For women: Negative pregnancy test during screening (Day to Day ) before CD and compliant with a medically-approved contraceptive regimen during and for months after the treatment period or documented to be surgically sterile (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for ? consecutive months; or receiving hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > mIU/mL).
Both pre- and postmenopausal women will be included in this study; premenopausal will be defined as < months since last menstrual period, no prior bilateral oophorectomy, and no use of hormone replacement therapy; postmenopausal status will be defined as the absence of menses for > months, serum follicle-stimulating hormone (FSH) > mIU/ml, or history of bilateral oophorectomy; perimenopausal women will be excluded, defined as menstrual cycle irregularity (variable cycle length that differs from normal by more than days) and an FSH > mIU/ml
Is a surgically sterile male or female, or is postmenopausal for at least year, at least years of age, with a follicle-stimulating hormone level > milli-International units per mL (mIU/mL)
Females of childbearing potential must have a negative pregnancy test =< days prior to registration, unless they are surgically sterile for at least months (i.e., hysterectomy), OR postmenopausal for at least months (follicle-stimulating hormone [FSH] > U/mL)
Please note, pre-menopausal will be defined as women meeting the following criteria:\r\n* Patients not currently on hormonal contraception with the presence of menses in the past months\r\n* If no menstruation in the past months, without hormonal manipulation, then confirmed follicle-stimulating hormone (FSH) < mlU/mL\r\n* If age < years and on hormonal contraception then patient will be eligible regardless of menstrual history\r\n* If age >= years and on hormonal contraception then FSH confirmed < mIU/mL
Both pre- and postmenopausal women will be included in this study; postmenopausal status will be defined as the absence of menses for > months, serum follicle-stimulating hormone (FSH) > mIU/ml, or history of bilateral oophorectomy
Ovarian insufficiency defined as an elevated follicle-stimulating hormone (FSH) over
Postmenopausal (confirmed by self-report on the Health History Questionnaire; menopausal status could also be confirmed by a recent [< months from enrollment] laboratory report documenting serum follicle-stimulating hormone [FSH] > mIU/ml and/or serum estradiol < pg/ml)
Postmenopausal as defined by ) no menstrual period in the past months; ) no menstrual period in the past months and an FSH level greater than ; or ) women who have had a bilateral oophorectomy
Pre-menopausal women as defined as four menstrual cycles within the last six months prior to pre-registration; women with less than menses within months prior to pre-registration, or women who have had a hysterectomy with ovaries intact will be considered premenopausal if follicle-stimulating hormone (FSH) level is < ; women who are using hormonal contraceptives that cause amenorrhea (e.g. injectable and extended oral contraceptives, hormone containing contraceptive ring, or hormone containing intrauterine device) will be considered eligible if they had a minimum of menstrual cycles within the last six months prior to starting on the contraceptive
Women with vasomotor symptoms with a uterus who are postmenopausal (no menstrual period for months) or in late menopause transition (no period for months and elevated follicle stimulating hormone [FSH])
Participants must be premenopausal (defined as < months since last menstrual period OR serum follicle-stimulating hormone [FSH] < mIU/mL)
Menopause as defined as no menses for year and/or follicle-stimulating hormone (FSH) >= . mIU/ml