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Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens
Sponsor: Gynuity Health Projects
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
Conditions
Interventions
Levonorgestrel
Participants in the levonorgestrel plus mifepristone group will receive one tablet of 1.5 mg levonorgestrel
Mifepristone
Participants in both groups will receive one tablet of 200 mg mifepristone