Dysautonomia International

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

Purpose

The Sponsor is developing a progestin-only contraceptive transdermal system (patch). The main purpose of this study is to look at how safe the study patch is and how well it works in preventing pregnancy. The study will also look at how well the study patch is tolerated. The study patch is a transdermal system that contains the active ingredient, progestin.

Condition

Female Contraception

Eligibility

Eligible Ages: Over 16 Years
Eligible Sex: Female
Accepts Healthy Volunteers: No

Inclusion Criteria

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.

Exclusion Criteria

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.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Prevention
Masking: None (Open Label)