Weekly Mifepristone
- User: Female
- Hormonal: Non-Hormonal
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Delivery type:
- Oral
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Intended Duration:
- Short-Acting
- Development Stage: Phase III
- Developer(s)/researcher(s): Women on Waves, Karolinska Institute, Leiden University Medical Center
Details
- API: Mifepristone
- Target: Progesterone Receptor, Glucocorticoid Receptor
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Mechanism of Action:
- Ovulation Inhibition
- Inactive Materials: Not Yet Determined
- Regimen: 1 Pill/Week
- MPT: Not Potential MPT
- Promising Attributes: Mifepristone has broad regulatory approval for other indications, and advocates for its contraceptive use suggest it may have a more favorable side effect profile than hormonal oral contraceptives.
Product Status
Active Clinical Research
History
Mifepristone has been hypothesized as a viable continuous and on demand contraceptive since its development, with evaluation in the 1990s and 2000s as a monthly 200mg method, which would require precise dose timing. In 2006, the National Institute for Family Planning China publishes results of a double blind RCT comparing 25mg and 50mg mifepristone as a weekly contraception, which reported no method failures and low bleeding, particularly in the 50mg arm.
2022: Moldovan regulators approve clinical trial evaluating use of RA-approved mifepristone 50 mg as a weekly contraceptive. Enrollment begins in Aug. 2023 with likely expansion to the Netherlands.
2023: Phase II/III trial initiates in Moldova, with date of final enrollment scheduled for 2026.
2024: Developer announces positive interim results from ongoing clinical research and intent to pursue additional funds for further clinical evaluation following completion of Ph II/III research.
2025: Developers initiate Phase III trial in Netherlands, intending to enroll 1186 participants.