Contraception Guidance Clause Samples

Contraception Guidance. There is no known drug interaction between RIST4721 and hormonal contraception. Male subjects are eligible to participate if they agree to the following from informed consent through 5 days after the last dose of study treatment: • Be abstinent and agree to remain abstinent OR • Must agree to use contraception/barrier (a male condom) and spermicide • A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: − Is not a WOCBP OR − Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency (see table below), from consent through 5 days after the last dose of study treatment, and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment. − A WOCBP must have negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) at screening and a negative urine pregnancy test before first administration of study treatment. On-treatment urine pregnancy tests will be done routinely as specified in the SoA. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required and results must be negative. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for those participating in clinical studies. Highly Effective Methodsa That Have Low User Dependency • Implantable progestogen-only hormone contraception associated with inhibition of ovulationb • Intrauterine device (IUD) (hormonal and non-hormonal) • Surgical sterilization • Bilateral tubal occlusion or ligation • Vasectomized partner (Vasectomized partner is a highly effective contraceptive method provided that the partner is the sole sexual partner of the WOCBP. If not, an additional highly effective method of contraception should be used. Spermatogenesis cycle is approximately 90 days.) Highly Effective Methodsa That Are User-Dependent • Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation − oral − intravaginal − transdermal − injectable • Progestogen-only hormone contraception associated with inhibition of ovulationb − oral − injectable • Sexual abstinence (Sexual abstinence is ...
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Contraception Guidance. Women of childbearing potential must agree to use (or have their male partner use) a highly effective contraception method, unless any of the following apply: • Has reached natural menopause, defined as at least 12 months of spontaneous amenorrhea without an alternative medical cause; • Is permanently sterile, following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy. Highly effective methods of contraception include the following: • Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal or transdermal • Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • Bilateral tubal occlusion (including ligation and blockage methods such as Essure™ at least 6 months prior to the initial Screening Visit [subjects with Essure must have prior confirmation of tubal occlusion by hysterosalpingogram])‌ • Sexual partner(s) who was documented to be vasectomized at least 6 months prior to the Screening Visit • Sexual abstinence from heterosexual intercourse Subjects will be provided with information on acceptable methods of contraception as part of the informed consent process and will confirm when they sign an ICF that they understand the requirements for avoidance of pregnancy during the course of the study. These methods of contraception are only effective when used consistently, correctly, and in accordance with the product label. The Investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
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