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

Study acronym: WOMEN&More
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Apr 2029 to Jun 1, 2027 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 1186 to confirmed 615 · Completion date: Apr 2030 to Jan 1, 2028 · 1 morev5 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1186 to confirmed 615
    • Completion date: Apr 2030 to Jan 1, 2028
    • Site details revised at 14 of 14 sites
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 2025 to May 2, 2025 · Eligibility criteria expanded, about 37 words · Site details revised at 14 of 14 sitesv4 Show 3 more changesShow less
    • Start date changed from estimate of Apr 2025 to May 2, 2025
    • Eligibility criteria expanded, about 37 words
    • Site details revised at 14 of 14 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria shortened, about 4 wordsv3 See this version in full on ClinicalTrials.gov ↗
  4. Primary completion date: Sep 2028 to Apr 2029 Start date: Sep 2024 to Apr 2025 · Primary endpoints: 2 to 3 · Study sites: 6 to 14 · 3 morev2 Show 6 more changesShow less
    • Start date: Sep 2024 to Apr 2025
    • Primary endpoints: 2 to 3
    • Study sites: 6 to 14
    • Completion date: Sep 2029 to Apr 2030
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: 3 to 9

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov