Assessing Use Of Mifepristone After Progestin Priming For Use As "Missed Period Pills"
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 139
- Locations
- 1
- Primary Endpoint
- Efficacy of missed period pill regimen
Study Overview
Brief Summary
This study will assess the effectiveness and acceptability of a 3-day missed period pill regimen.
Detailed Description
Missed period pills (MPPs) are medications used for uterine evacuation among women with late menses who have not confirmed pregnancy status. Provision of MPPs could expand reproductive service options for individuals in a variety of settings. This study will collect data on the efficacy, safety, and acceptability of a 3-day missed period pill regimen among individuals with missed menses of 1-10 days
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 18-49 years
- •General good health
- •Does not want to be pregnant
- •History of regular monthly menstrual cycles (±3 days)
- •Missed menses of 1 to 10 days as verified by report of last menstrual period
- •Sexual activity in the past month
- •Willing and able to sign consent forms
- •Willing to return for a follow-up visit
- •Willing to provide a urine sample at enrollment and at follow-up
Exclusion Criteria
- •Known allergies or contraindications to mifepristone
- •Symptoms of or risk factors for ectopic pregnancy, such as vaginal bleeding or spotting within the past week; unilateral pelvic pain or significant bilateral pelvic pain within the past week; prior ectopic pregnancy; prior permanent contraception or other tubal surgery
- •Current use of an IUD, contraceptive implant or injectable
Arms & Interventions
Missed period pill regimen
1.5 mg levonorgestrel given on day 1 200 mg mifepristone given on day 3
Intervention: Levonorgestrel (Drug)
Missed period pill regimen
1.5 mg levonorgestrel given on day 1 200 mg mifepristone given on day 3
Intervention: Mifepristone (Drug)
Outcomes
Primary Outcomes
Efficacy of missed period pill regimen
Time Frame: Up to 28 days after administration of levonorgestrel
Proportion of participants not pregnant at follow-up among those who were pregnant at enrollment
Secondary Outcomes
- Effectiveness of missed period pill regimen(Up to 28 days after administration of levonorgestrel)
- Effectiveness at inducing return of menses within 10 days(Up to 10 days after administration of levonorgestrel)
- Occurrence of treatment-emergent adverse events and/or side effects (safety and tolerability)(Up to 28 days after administration of levonorgestrel)
- Acceptability of missed period pills(Up to 28 days after administration of levonorgestrel)