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

Launched by MYLAN PHARMACEUTICALS INC · Nov 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new contraceptive patch that contains a hormone called progestin, which is designed to help prevent pregnancy. The main goals of the study are to evaluate how safe the patch is, how effective it is in preventing pregnancy, and how well women tolerate using it. Women who are healthy, between 16 and 43 years old, and want to avoid pregnancy while using hormonal birth control for at least a year may be eligible to participate. They should have regular menstrual cycles and agree not to use other forms of contraception during the study.

If you join the study, you will receive the contraceptive patch and will be monitored to see how well it works for you. It's important to know that certain conditions, like pregnancy or known allergies to progestin, may prevent someone from participating. This trial is currently recruiting participants, so if you are interested in learning more about it, you should speak with your healthcare provider for additional information.

Gender

FEMALE

Eligibility criteria

• Inclusion 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.
• 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.