Randomized Trial Comparing Progestin With Mifepristone Versus Mifepristone Alone for Use as Missed Period Pills
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 286
- Primary Endpoint
- Effectiveness of the missed period pills regimen
Study Overview
Brief 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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 15-49 years
- •General good health
- •Does not want to be pregnant
- •History of regular monthly menstrual cycles (+/- 3 days)
- •Missed menses of 2 to 8 days
- •Sexual activity in the past month
- •Willing and able to sign consent forms
- •Willing to return for a follow-up visit
- •Willing to provide urine sample at enrollment and follow-up
Exclusion Criteria
- •Known allergies or contraindications to either study drug
- •Symptoms or risk factors for ectopic pregnancy
- •Current use of an IUD, contraceptive implant or injectable
Arms & Interventions
Levonorgestrel plus mifepristone
Women randomized to take one pill containing 1.5 mg levonorgestrel followed one to two days later by 200 mg mifepristone.
Intervention: Levonorgestrel (Drug)
Levonorgestrel plus mifepristone
Women randomized to take one pill containing 1.5 mg levonorgestrel followed one to two days later by 200 mg mifepristone.
Intervention: Mifepristone (Drug)
Placebo plus mifepristone
Women randomized to take one placebo pill followed one to two days later by 200 mg mifepristone.
Intervention: Mifepristone (Drug)
Outcomes
Primary Outcomes
Effectiveness of the missed period pills regimen
Time Frame: Two weeks
Proportion of women not pregnant at follow-up among all women enrolled, including those who were pregnant and not pregnant at enrollment
Efficacy of the missed period pills regimen
Time Frame: Two weeks
Proportion of women not pregnant at follow-up who were determined to be pregnant at enrollment
Secondary Outcomes
- Effectiveness at inducing return of menses within 10 days of missed menses(One to two weeks)
- Safety/side effects(Two weeks)
- Acceptability(Two weeks)