Study to Evaluate Contraceptive Efficacy and Safety of a Progestin Only Patch in Women of Childbearing Potential

Exclusion Criteria

• •1. Known or suspected pregnancy or planning pregnancy during next 12 months.
• •2. Participants with known hypersensitivity or intolerance to progestins, or any components of the progestin patch.
• •3. History or presence of dermal sensitivity to medicated patches or to topical applications including bandages, surgical tape.
• •4. Known infertility (current or known history) or history of sterilization in either partner.
• •5. Received injectable hormonal contraceptive therapy within 10 months of study enrollment.
• •6. Current use of hormonal contraceptive implants.
• •7. Has non-hormonal or hormonal intrauterine device (IUD) in place; or has had a recent IUD removal without one spontaneous menses after removal prior to the date of enrollment.
• •8. Recent surgical or medical abortion, miscarriage, ectopic pregnancy, or vaginal or cesarean delivery.
• •9. Participants lactating at the time of screening into the study or has occurrence of less than 3 regular menstrual cycles after cessation of lactation.
• •10. Anticipates routine use of condoms or any other form of back-up contraception for protection from sexually transmitted infections during the study or for emergency contraception.
• •11. Participants having a known contraindication to progestin-only contraception.
• •12. Known or suspected progestin sensitive malignant or premalignant conditions including but not limited to carcinoma of endometrium, ovary, or fallopian tubes.
• •13. Skin abnormality (e.g., tattoo or scar) at all possible application sites.
• •14. Long-term treatment with drugs or herbal products that are moderate/strong inducers or inhibitors of CYP3A4.
• •15. Has uncontrolled thyroid disorder (thyrotoxicosis or myxedema).
• •16. Has diagnosis of hereditary angioedema.
• •17. Participants with abnormal significant liver function tests as measured by liver function tests
• •18. Has a significantly abnormal cervical cancer screening test.
• •19. Participants with chlamydial or gonorrheal infection at screening.
• •20. Has unexplained vaginal bleeding within the past 6 months or any abnormal bleeding which is expected to recur during the study.