Methods of Contraception Sample Clauses

Methods of Contraception. Women of childbearing potential must agree to use highly effective contraceptive method(s) while on study drug and for at least 3 months after the last dose of MIRV. A woman of childbearing potential is a woman who is considered fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. The following birth control methods may be considered highly effective (failure rate of less than 1% per year): • Combined (estrogen and progesterone) hormonal contraception associated with inhibition of ovulation − Oral − Intravaginal − Transdermal • Progesterone-only hormonal contraception associated with inhibition of ovulation: − Oral − Injectable − Implantable • Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • Bilateral tubal occlusion • Vasectomized partner • Sexual abstinence Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the patient’s preferred and usual lifestyle and if considered acceptable by local regulatory agencies and Institutional Review Board/Independent Ethics Committee (IECs /IRBs). Periodic abstinence (eg, calendar, ovulation, symptom-thermal, post- ovulation methods, etc) and withdrawal are not acceptable methods of contraception. If a contraceptive method listed above is restricted by local regulations/guidelines, then it does not qualify as an acceptable method of contraception for patients participating at sites in this country/region. Patients should be informed that taking the study medication may involve unknown risks to the fetus (unborn baby) if pregnancy were to occur during the study. To participate in the study WCBP must adhere to the contraception requirement (described above) from the day of study medication initiation (or 14 days before the initiation of study medication for oral contraception) through the duration of study treatment and for at least 3 months after the last dose of MIRV. If there is any question that a WCBP will not reliably comply with the requirements for contraception, that patient should not be entered into the study.
Sample 1
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