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

Eligibility Criteria

• 1. Healthy, post-menarcheal and premenopausal women at risk of pregnancy who are at least 16 years of age.
• 2. Desires to avoid pregnancy, is seeking to use hormonal contraception for at least 1 year.
• 3. Has negative UPT results at screening and at enrollment visits.
• 4. Has normal, regular menstrual cycles that are between 21 and 35 days in duration over the last 6 months.
• 5. Engages in regular heterosexual vaginal intercourse (at least once per cycle), with a partner who is not known to be sub fertile or infertile.
• 6. Agrees not to use other contraceptives or other methodology to prevent pregnancy during the study.
• 7. Able to understand and voluntarily provide written informed consent or assent (if the participant is adolescent prior to undergoing any trial related procedure) to participate in the study.
• 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.