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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
286
Participants in the levonorgestrel plus mifepristone group will receive one tablet of 1.5 mg levonorgestrel
Participants in both groups will receive one tablet of 200 mg mifepristone
Efficacy of the missed period pills regimen
Proportion of women not pregnant at follow-up who were determined to be pregnant at enrollment
Time frame: Two weeks
Effectiveness of the missed period pills regimen
Proportion of women not pregnant at follow-up among all women enrolled, including those who were pregnant and not pregnant at enrollment
Time frame: Two weeks
Effectiveness at inducing return of menses within 10 days of missed menses
Proportion of participants who experience menstrual bleeding after taking the study medications
Time frame: One to two weeks
Safety/side effects
Incidence of side effects and complications
Time frame: Two weeks
Acceptability
Proportion of participants who report that the missed period pills service was acceptable or highly acceptable
Time frame: Two weeks
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