NCT06672016

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

A Phase 3, Multicenter, Open-Label, Single-Arm Study of MR-130A-01 in Women of Childbearing Potential to Evaluate Contraceptive Efficacy and Safety

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Unintended pregnancy continues to be a significant reproductive health problem worldwide. Although the increase in the availability of longer-acting contraceptive methods has improved the situation, the continuing development of newer safe and effective contraception is crucial for women's health. The development of a progestin-only contraceptive with more convenient dosing may provide women with additional options. The investigational patch is intended to provide an option for women who may not be able to use estrogen-containing combined hormonal contraceptives

Conditions

• Female Contraception

Interventions

Type	Name	Description
DRUG	Transdermal system containing progestin	MR-130A-01 transdermal system, patch to be used for female contraception

Timeline

• Start date: 2025-01-13
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2024-11-04
• Last updated: 2026-02-24

Locations

57 sites across 1 country: United States

Regulatory

• FDA-regulated drug study