Trials / Completed
CompletedNCT05139121
Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles
A Phase 3, Multicenter, Open-Label, Single Arm Study of MR-100A-01 in Women of Childbearing Potential to Evaluate Contraceptive Efficacy and Safety
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,319 (actual)
- Sponsor
- Mylan Technologies Inc. · Industry
- Sex
- Female
- Age
- 16 Years
- Healthy volunteers
- Accepted
Summary
Study of the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01 in approxmiately 1200 women for up to 13 cycles
Detailed description
MR-100A-01 is a TDS of norelgestromin 4.86 mg/ethinyl estradiol 0.264 mg. This study will evaluate the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MR-100A-01 | Transdermal contraceptive delivery system |
Timeline
- Start date
- 2021-10-26
- Primary completion
- 2025-01-15
- Completion
- 2025-01-15
- First posted
- 2021-12-01
- Last updated
- 2025-01-28
Locations
100 sites across 3 countries: United States, Canada, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05139121. Inclusion in this directory is not an endorsement.