Clinical Trial

Efficacy, Safety, and Acceptability of Mifepristone 50 mg Once-weekly as a Contraceptive

Study acronym: WOMEN&More
Active, Not Recruiting Phase 3
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Summary
Participants in the study will use mifepristone 50 mg once-a-week for one year as a contraceptive. With this, we want to confirm that the chances of getting pregnant while using this contraceptive are very small. We also want to demonstrate that the use of mifepristone is safe, and it does not lead to any severe health problems. We expect fewer side effects compared to other frequently used contraceptives with hormones. Mifepristone does not contain these hormones. It is important to know how people experience that use of one tablet a week.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-04-29; most recent amendment 2026-06-04.
Status change: Recruiting → Active, Not Recruiting 2026-06-04
Status change: Not Yet Recruiting → Recruiting 2025-09-15
Trial Details
NCT Number NCT06394999
Lead Sponsor Leiden University Medical Center
Collaborators: Karolinska Institutet, Women on Waves, Children's Investment Fund Foundation
Conditions Female Contraception
Enrollment 615 participants
Start Date 2025-05-02
Primary Completion 2027-06-01 (estimated)
Study Completion 2028-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-08