[c09aa8]: / clusters / 9knumclustersv2 / clust_2829.txt

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a contraceptive implant
an oral contraceptive** (with additional barrier method) OR
Must be on a stable dose of the same oral hormonal contraceptive product for at least weeks before dosing with study drug and for the duration of the study
Use an approved contraceptive method.
Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within days of starting study drug; in addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; or barrier contraceptive with spermicide) while on study drug; WCBP must agree to have pregnancy tests every weeks while on study drug
Women of childbearing potential who are on stable oral contraceptive therapy or intrauterine or implant device for at least days prior to the study, or abstain from sexual intercourse as a way of living
Established hormonal contraceptive methods: oral, injectable, or implant. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least weeks prior to dosing and must continue to use the same contraceptive during the study and for days after study drug discontinuation. Female participants exempt from this requirement are participants who practice total abstinence or have a male partner who is vasectomized with confirmed azoospermia. If currently abstinent, the participant must agree to use a double barrier method as described above if they become sexually active during the Treatment Cycles, and for days after study drug discontinuation
Male or female not willing to use adequate contraceptive precautions during the study period. Females must either be surgically sterile, post-menopausal for months, or use a contraceptive approved by sponsor.
Had unprotected sexual intercourse within days before study entry and who do not agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for days after study drug discontinuation.
Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least weeks before dosing and who do not agree to use the same contraceptive during the study or for days after study drug discontinuation.
a contraceptive implant
an oral contraceptive (with additional barrier method) (Note: Participants must be on a stable dose of the same oral hormonal contraceptive product for at least weeks before dosing with study drug and for the duration of the study.) OR
The patient (male and female) agrees to use acceptable contraceptive methods for the duration of time on the study, and continue to use acceptable contraceptive methods for month after the last dose of SL-.
Male patients should be willing to use barrier contraceptive (ie, condoms) until months after last study drug is taken.
Physiologically incapable of becoming pregnant, postmenopausal, or negative pregnancy test and agree to use adequate contraception (e.g., oral contraceptive, double barrier method, intra-uterine device, intra-muscular contraceptive).
Agreement to use highly effective contraceptive methods as stated in protocol
Subjects must agree to use a condom and acceptable contraceptive method with their partner during the study and for one month after the last dose of vaccines
Not currently pregnant during the study; participants will be informed that the use of contraceptive pills is contraindicated because it may interfere with the study drug and it may be harmful to the woman who has been diagnosed with breast cancer
Male patients willing to use adequate contraceptive measures.
Sexually active men and their sexual partners must use effective contraceptive methods from the time of subject informed consent and until at least months after discontinuing study drug
Female subjects must, as appropriate to age and at the discretion of the study Investigator, either commit to true abstinence from heterosexual contact and/or agree to the use of two reliable forms of approved and effective contraceptive methods simultaneously. The two methods of reliable contraception must include one highly effective method (ie, oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; vasectomized partner) and one additional effective barrier method (ie, male condom, diaphragm, cervical cap) days prior to starting pomalidomide, throughout the entire duration of study treatment including dose interruptions and days after discontinuation of pomalidomide.
A contraceptive implant
An oral contraceptive OR
Had unprotected sexual intercourse within days before study entry and who do not agree to use a highly effective method of contraception (eg, true abstinence if it is their preferred and usual lifestyle [defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments], an intrauterine device, a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for months after study drug discontinuation;
Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least weeks before dosing and who do not agree to use the same contraceptive during the study or for months after study drug discontinuation.
Unwilling to use contraceptive methods for at least months after starting treatment
Pregnancy or lactation period; patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices) during study treatment
Use approved contraceptive methods.
If sexually active, patients must agree to use appropriate contraceptive measures for the duration of the study and for months afterwards as stated in the informed consent
For those patients who are sexually active, they must be willing to use barrier contraceptive methods during the period of treatment on this trial (and for four weeks after the last DNA immunization treatment for patients in Arm )
For male patients with a female partner of childbearing age, they may participate if they agree to either abstinence or effective contraceptive methods throughout the treatment period and up to days after discontinuing treatment
Male patients must use an effective contraceptive method during the study and for a minimum of weeks after study treatment
Pregnant or lactating patients; patients of childbearing potential must implement contraceptive measures during study treatment and for months after the last dose of the study drug
If sexually active, patients must agree to take contraceptive measures for the duration of the treatments
All patients of childbearing potential must be willing to use a contraceptive method before, during, and for at least two months after the T cell infusion
Patients capable of reproduction and male patients who have partners capable of reproduction must agree to use an effective contraceptive method during the course of the study and for months following the completion of their last treatment.
A contraceptive implant;
An oral contraceptive (must be on a stable dose of the same oral hormonal contraceptive product for at least weeks before dosing with study drug and for the duration of the study and for months after study drug discontinuation); or
Must be using at least effective contraceptive method at screening and agree to practice effective contraceptive methods for study duration, starting Screening through days after stopping study drug
Agrees to contraceptive use while on study if sexually active
Agree to use of the birth control methods listed: an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g., Norplant), or an injectable contraceptive (e.g., Depo-Provera) for at least one month prior to entering the study and will continue its use through at least days after the last dose of the study medication. A barrier method of contraception (e.g., condom or diaphragm with spermicide) while participating in the study and days after the last dose of study medication.
Azoospermic males should also use double barrier contraceptive methods to avoid contamination of the non-treatment sexual partner.
Female and male patients must use an effective contraceptive method during the study and for at least months thereafter
Subjects must use effective contraceptive methods during the study and for three months following the last dose of study product, if of reproductive age and still retain fertility potential.
For men and women of reproductive potential, agreement to use an effective contraceptive method from the time of screening and throughout their time on study; effective contraceptive methods consist of prior sterilization, intra-uterine device, oral or injectable contraceptives, and/or barrier methods; abstinence alone is not considered an adequate contraceptive measure for the purposes of this study
Concurrent hormonal contraceptive use
No concurrent hormonal oral contraceptive use
Female subjects must, as appropriate to age and at the discretion of the study Investigator, either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis) and/or agree to the use of two reliable forms of approved and effective contraceptive methods simultaneously. The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) without interruption, days prior to starting lenalidomide treatment, throughout the entire duration of study treatment including dose interruptions and days after the end of study treatment.
Male patients (except those with prior surgical contraceptive procedures) with female partners who are of childbearing potential: Recommendation is for male and partner to use effective contraceptive methods, such as latex condoms, during the study
The patient (male and female) agrees to use acceptable contraceptive methods for the duration of time on the study, and continue to use acceptable contraceptive methods for months after the last infusion of SL-.
Do not agree to use a highly effective method of contraception (ie, total abstinence, [if it is their preferred and usual lifestyle], an intrauterine device or intrauterine system, a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) within days before study entry and throughout the entire study period and for days after study drug discontinuation.
Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least weeks before dosing and who do not agree to use the same contraceptive during the study and for days after study drug discontinuation.
If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use at least one highly effective or two effective contraceptive methods during the dosing period and for three months after last LV injection. If enrolled on the arm that includes pembrolizumab, agrees to use highly effective contraceptive methods during the dosing period and for days after last injection of study drug.
Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis) or agree to the use of a physician-approved contraceptive method (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner) without interruption, while on CC- (including dose interruptions); and for months following the last dose of IP; and
Agree to use at least two effective contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) or agree to practice true abstinence throughout the study, and for months following the last dose of IP; and
do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for days after study drug discontinuation,
Females of childbearing potential must not have had unprotected sexual intercourse within days before study entry and must agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for days after study drug discontinuation. If currently abstinent, the subject must agree to use a double barrier method as described above if she becomes sexually active during the study period or for days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least weeks before dosing and must continue to use the same contraceptive during the study and for days after study drug discontinuation.
The patient (men and WOCBP) agrees to use acceptable contraceptive methods for the duration of time on the study, and continue to use acceptable contraceptive methods for month after the last dose of study therapy. Patients receiving combination therapy must agree to use acceptable contraceptive methods for the duration of time on the study and continue to use acceptable contraceptive methods for months after the last dose of study therapy.
Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
Sexually active participants (men and women) must agree to use highly effective contraceptive methods during the course of the study and for months after completing treatment with radium-
For men: Compliant with a medically-approved contraceptive regimen during and for months after the treatment period or documented to be surgically sterile. Men whose sexual partners are of child-bearing potential must agree to use a medically-approved contraceptive regimen during the study and for months after the treatment period.
Agreement to use highly effective contraceptive methods per protocol
Appropriate contraceptive measures must be taken
Sexually active men and their sexual partners must use effective contraceptive methods from the time of participant informed consent and until at least months after discontinuing study drug
Females of childbearing potential must not have had unprotected sexual intercourse within days before study entry and must agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for days after study drug discontinuation. If currently abstinent, the subject must agree to use a double barrier method as described above if she becomes sexually active during the study period or for days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least weeks before dosing and must continue to use the same contraceptive during the study and for days after study drug discontinuation.
Male and female patients must use an effective contraceptive method during the study and for at least months after study treatment
If a female of childbearing potential, a negative pregnancy test must be confirmed before enrolment and use of double-barrier contraception, oral contraceptive plus barrier contraceptive, or confirmation of having undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation.
Pregnancy or breast feeding at the time of study enrollment. Eligible subjects of reproductive potential (both sexes) must agree to use adequate contraceptive methods during study therapy.
Male and female participants must use an effective contraceptive method during the study and for a minimum of months after study treatment
Unless practicing complete abstinence from heterosexual intercourse, sexually active FCBP must agree to use adequate contraceptive methods as specified in Pregnancy Prevention Risk Minimization Plan.
Agreement to use adequate contraceptive methods per protocol
Male patients willing to use adequate contraceptive measures.
Meets contraceptive requirements defined in the protocol
Females of childbearing potential must not have had unprotected sexual intercourse within days before study entry and must agree to use a highly effective method of contraception (example, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, a combination oral contraceptive (estrogen/progesterone), or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for days after study drug discontinuation. If currently abstinent, the participant must agree to use a double barrier method as described above if she becomes sexually active during the study period or for days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least days before dosing and must continue to use the same contraceptive during the study and for days after study drug discontinuation.
Unless practicing complete abstinence from heterosexual intercourse, sexually active FCBP must agree to use adequate contraceptive methods as specified in the PPRMP. *For Arm C, subjects must agree to use adequate contraceptive methods for months (please refer to the obinutuzumab IB, PI, and SmPC).
Patients if sexually active and able to father children, will agree to use adequate contraceptive methods (barrier contraceptive with spermicide; vasectomy; abstinence) prior to study entry and for the duration of study participation
Females who are pregnant, nursing, or not inclined to use adequate contraceptive methods if necessary to prevent pregnancy during the study
Male patients willing to use adequate contraceptive. (See Appendix B)
For males, participants must agree to use adequate contraceptive measures including at least barrier method, and abstain from sperm donation throughout the course of the study and for at least days after the last administration of investigational product.
The patient (male and female) agrees to use acceptable contraceptive methods for the duration of time on the study, and continue to use acceptable contraceptive methods for months after the last infusion of SL-.
Established hormonal contraceptive methods: oral, injectable or implant. Female subjects who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product from the last menstrual period prior to randomization, and must continue to use the same hormonal contraceptive product during study treatment, and for months after the first dose of study treatment.
Male or female patients who are sexually active and unwilling to take contraceptive measures for the duration of the treatments and for months following discontinuation of ACIV
Had unprotected sexual intercourse within days before study entry and who do not agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as a condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for days after study drug discontinuation
Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least weeks before dosing and who do not agree to use the same contraceptive during the study or for days after study drug discontinuation
If sexually active, patients will take contraceptive measures for the duration of protocol treatment and continue until two months after treatment; the effectiveness of hormonal contraceptives containing levonorgestrel has been shown to be reduced by perampanel at a mg dose; therefore, alternative or back-up methods of contraception are recommended
If sexually active, patients will take contraceptive measures for the duration of protocol treatment and continue until one month after treatment; the efficacy of hormonal contraceptives during and for days following the last dose of aprepitant may be reduced; alternative or back-up methods of contraception must be used
Females of child-bearing potential, who are not using adequate contraceptive measures (including condoms, birth control pills, intrauterine devices, contraceptive implants, or other United States [US] Food and Drug Administration [FDA]-approved contraceptives)
Subjects must agree to read patient instructions regarding use of barrier contraceptive devices while on treatment with fluocinonide cream in the informed consent
Use of an effective contraceptive method during the course of the study and for months following the last administration of Investigational Product
Agreement to utilize effective contraceptive methods during the study (for one year)
For participants of childbearing potential, not pregnant, and use of effective contraceptive methods during the trial and within months following radiotracer injection
Female subjects of childbearing potential must agree to the use of two physician-approved contraceptive methods simultaneously or practice complete abstinence while on study
NORMAL GROUP: If subject is presently using oral contraceptives at the beginning of the study, does not plan to stop oral contraceptive use for the duration of the study
NORMAL GROUP: If subject is not using oral contraceptives at the beginning of the study, does not plan to begin oral contraceptive use during the duration of the study
For men of childbearing potential, the use of effective contraceptive methods during the trial and within months following radiotracer injection
If of child-bearing potential, agree to continued use of two reliable methods of contraceptive from study entry (time of informed consent) through days after BLZ- administration. Male subjects with vasectomy do not need to use a second form of contraceptive.
Females of childbearing potential should avoid becoming pregnant and use highly effective contraception while on treatment with lenvatinib and for at least month after finishing treatment. Females of childbearing potential must not have had unprotected sexual intercourse within days before study entry and must agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least weeks before dosing and must continue to use the same contraceptive during the study and for days after study drug discontinuation. Women using oral hormonal contraceptives should add a barrier method.