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Clinical Trials in the USA / NCT06672016
Active, not recruiting Phase 3

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

NCT06672016 · tracked via the Priya Life Science USA tracker
Sponsor
Mylan Pharmaceuticals Inc
Phase
Phase 3
Started
2025-01-13
Last updated
2026-05-06

Condition(s) studied

Female Contraception

Investigational drug(s) / intervention(s)

Transdermal system containing progestin

Transdermal system containing progestin: MR-130A-01 transdermal system, patch to be used for female contraception

Study summary

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.

Eligibility

Sex
FEMALE
Min age
16 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (56)

FacilityCityRegionStatus
Alabama Clinical Therapeutics, LLC Birmingham Alabama
SEC Clinical Research Dothan Alabama
AMR Mobile Mobile Alabama
Velocity Clinical Research Mobile Alabama
Velocity Clinical Research Phoenix Arizona
Precision Trials Phoenix Arizona
Velocity Clinical Research Santa Ana Huntington Park California
Essential Access Health Los Angeles California
Women's Health Care Research Corp San Diego California
WR-Medical Center For Clinical Research San Diego California
Altus Research Lake Worth Florida
OB GYN Associates of Mid Florida P.A. Leesburg Florida
Genoma Research Group Miami Florida
Spotlight Research Center Miami Florida
New Age Med Research Corp Miami Florida
Sensible Healthcare, LLC Ocoee Florida
Innovation Medical Research Center Palmetto Bay Florida
Clinical Research Center of Florida Pompano Beach Florida
CenExel iResearch LLC Decatur Georgia
CenExel Savannah Savannah Georgia
Javarra and Privia Med Savannah Georgia
Leavitt ClinResearch Idaho Falls Idaho
Women's Healthcare Associates P.A. Idaho Falls Idaho
AMR Newton Newton Kansas
AMR Lexington Lexington Kentucky
Clinical Trials Management, LLC Covington Louisiana
Velocity Clinical Research Covington Louisiana
Velocity Clinical Research Lafayette Louisiana
PraetorianPharmaResearch LLC Marrero Louisiana
Southern Clinical Research Associates Metairie Louisiana
Velocity Clinical Research New Orleans New Orleans Louisiana
Valley OBGYN Clinic PC Saginaw Michigan
Velocity Clinical Research Gulfport Mississippi
Alliance for Multispecialty Research Kansas City Missouri
M3 Wake Research Inc Las Vegas Nevada
Excel Clinical Research Las Vegas Nevada
Essential Women's Health Las Vegas Nevada
CenExel Hassman Research Institute Marlton New Jersey
Albuquerque Clinic Trials Inc Albuquerque New Mexico
Bosque Women's Care Albuquerque New Mexico

+ 16 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06672016 on ClinicalTrials.gov ↗ ← All trials in the USA