> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-evaluate-contraceptive-efficacy-and-safety-of-a-f68f62a6-c961-4da8-b2ef-a507b4dad875 > Record changed: 2026-10-13 # Study to Evaluate Contraceptive Efficacy and Safety of a Progestin Only Patch in Women of Childbearing Potential NCT06672016 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) Participants 1,630 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) Lead sponsor Mylan Pharmaceuticals Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) Start date 2025-01-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) Number of sites 56 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Short title** Study to Evaluate Contraceptive Efficacy and Safety of a Progestin Only Patch in Women of Childbearing Potential Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Official title** A Phase 3, Multicenter, Open-Label, Single-Arm Study of MR-130A-01 in Women of Childbearing Potential to Evaluate Contraceptive Efficacy and Safety Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) ## Dates **Completion date** 2027-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **First posted** 2024-11-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Registry last updated** 2026-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Primary completion date** 2027-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Start date** 2025-01-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) ## Size and sites **Participants** 1,630 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Planned participants** 1,630 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Number of sites** 56 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Lead sponsor** Mylan Pharmaceuticals Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) ## Identifiers **Registry ID** NCT06672016 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **ClinicalTrials.gov ID** NCT06672016 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Prevention **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) ## Outcomes ### Primary outcomes 1. To determine the contraceptive efficacy of progestin only patch when used over 13 cycles Timeframe: 13 cycles \[of 4 weeks (28 days) The primary efficacy endpoint will be pregnancy rate described by Pearl Index (PI). PI is defined as the number of pregnancies per 100 women-years. ### Secondary outcomes 1. To determine the efficacy in obese population (Body mass index (BMI) ≥30.0 kg/m2) Timeframe: 13 cycles \[of 4 weeks (28 days) Assessment of PI in obese population (Body mass index (BMI) ≥30.0 kg/m2). 2. To determine the efficacy in non-obese population (Body mass index (BMI) <30.0 kg/m2) Timeframe: 13 cycles \[of 4 weeks (28 days) Assessment of PI in non-obese population (BMI \\<30.0 kg/m2). 3. Cycle-wise and cumulative pregnancy rates over 1 year Timeframe: 13 cycles \[of 4 weeks (28 days) Assessment of cycle-wise and cumulative pregnancy rates over 1 year using life table analysis. 4. Method failure PI Timeframe: 13 cycles \[of 4 weeks (28 days) Assessment of method failure PI. 5. Incidence of adverse events and serious adverse events Timeframe: 13 cycles \[of 4 weeks (28 days) Assessment of adverse events and serious adverse events. 6. Incidence of application site reactions Timeframe: 13 cycles \[of 4 weeks (28 days) Assessment of application site reactions. 7. Unscheduled bleeding Timeframe: 13 cycles \[of 4 weeks (28 days) Assessment of number of episode and days of unscheduled bleeding, proportion of participants reporting unscheduled bleeding. 8. Adhesion performance Timeframe: 13 cycles \[of 4 weeks (28 days) Assessment of patch adhesion performance as measured by 'Self-Reported Scoring System of Patch Adhesion Assessment Scale' Scores range from 0 to 4 where score 0 indicates the patch has essentially no lift off the skin and score 4 indicates the patch is detached and is completely off the skin. 9. progestin plasma concentrations Timeframe: 5 cycles \[of 4 weeks (28 days) Evaluation of progestin exposure in the subset of participants. PK samples for evaluation of progestin concentrations will be collected during cycles 2 and 5, for population PK and exposure-response analysis. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) ## Eligibility **Sex** Female **Age groups** Children, Adults, Older adults **Minimum age** 16 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) ## Sites - Alabama Clinical Therapeutics, LLCBirmingham, United States - SEC Clinical ResearchDothan, United States - AMR MobileMobile, United States - Velocity Clinical ResearchMobile, United States - Velocity Clinical ResearchPhoenix, United States - Precision TrialsPhoenix, United States - Velocity Clinical Research Santa AnaHuntington Park, United States - Essential Access HealthLos Angeles, United States - Women's Health Care Research CorpSan Diego, United States - WR-Medical Center For Clinical ResearchSan Diego, United States - Altus ResearchLake Worth, United States - OB GYN Associates of Mid Florida P.A.Leesburg, United States - Genoma Research GroupMiami, United States - Spotlight Research CenterMiami, United States - New Age Med Research CorpMiami, United States - Sensible Healthcare, LLCOcoee, United States - Innovation Medical Research CenterPalmetto Bay, United States - Clinical Research Center of FloridaPompano Beach, United States - CenExel iResearch LLCDecatur, United States - CenExel SavannahSavannah, United States - Javarra and Privia MedSavannah, United States - Leavitt ClinResearchIdaho Falls, United States - Women's Healthcare Associates P.A.Idaho Falls, United States - AMR NewtonNewton, United States - AMR LexingtonLexington, United States And 31 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06672016) ## Related records ### Drugs (1) - [Carrageenan](https://trialight.com/data/asset/carrageenan-0552340c-094a-45ba-80ce-f6d0ef6e2f37.md) ### Lead sponsors (1) - [Mylan Pharmaceuticals Inc](https://trialight.com/data/company/mylan-pharmaceuticals-inc-1941ed6f-fc8c-495d-8d5d-56af81f02690.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. Registries lag, and so can we. - Trialight puts clinical, regulatory, genetic and commercial data for biotech and pharma in one place, with every value linked to its source. 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