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

NCT06394999 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1186

Last updated 2025-09-16

No results posted yet for this study

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.

Conditions

  • Female Contraception

Interventions

DRUG

Mifepristone 50 mg

Once-weekly oral mifepristone 50 mg

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Women on Waves

    collaborator UNKNOWN

  • Children's Investment Fund Foundation

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Rebecca Gomperts, PhD · Leiden University Medical Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-02
Primary Completion
2029-04-30
Completion
2030-04-30

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06394999 on ClinicalTrials.gov