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NOT YET RECRUITING
NCT06492889
PHASE2/PHASE3

Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens

Sponsor: Gynuity Health Projects

View on ClinicalTrials.gov

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)

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

Key Details

Gender

FEMALE

Age Range

18 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

286

Start Date

2024-07-22

Completion Date

2025-06-30

Last Updated

2024-07-18

Healthy Volunteers

Yes

Interventions

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