NCT06492889

Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens

Randomized Trial Comparing Progestin With Mifepristone Versus Mifepristone Alone for Use as Missed Period Pills

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The goal of this trial is to examine the efficacy and acceptability of two medication regimens at inducing a return of menses when used 2-8 days after a missed period. The first regimen consists of one dose of 1.5 mg levonorgestrel followed one to two days later by one dose of 200 mg mifepristone. The second regimen will consist of one dose of a placebo pill, followed one to two days later by one dose of 200 mg mifepristone. The investigators will assess and compare the efficacy of both regimens (proportion of women in each group not pregnant at follow-up who were determined to be pregnant at enrollment), and the effectiveness of both regimens (proportion of all participants not pregnant at follow-up among all participants enrolled)

Conditions

• Pregnancy Early
• Pregnancy Related

Interventions

Type	Name	Description
DRUG	Levonorgestrel	Participants in the levonorgestrel plus mifepristone group will receive one tablet of 1.5 mg levonorgestrel
DRUG	Mifepristone	Participants in both groups will receive one tablet of 200 mg mifepristone

Timeline

• Start date: 2024-07-22
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2024-07-09
• Last updated: 2024-07-18