Assessing Use Of Mifepristone After Progestin Priming For Use As Missed Period Pills

Study Overview
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Brief Summary
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This study will assess the effectiveness and acceptability of a 3-day missed period pill regimen.

Detailed Description
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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

Official Title
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Assessing Use Of Mifepristone After Progestin Priming For Use As Missed Period Pills

Conditions
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Missed Menstrual Period

Intervention / Treatment
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* Drug: Levonorgestrel
* Drug: Mifepristone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Simon's two-stage design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Missed period pill regimen<br>1.5 mg levonorgestrel given on day 1 200 mg mifepristone given on day 3 | Drug: Levonorgestrel<br>* All participants receive 1.5 mg levonorgestrel on day 1<br>Drug: Mifepristone<br>* All participants receive 200 mg mifepristone on day 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of missed period pill regimen | Proportion of participants not pregnant at follow-up among those who were pregnant at enrollment | Up to 28 days after administration of levonorgestrel | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of missed period pill regimen | Proportion of all enrolled participants not pregnant at follow-up (among those who were and were not pregnant at enrollment) | Up to 28 days after administration of levonorgestrel | 
| Effectiveness at inducing return of menses within 10 days | Proportion of participants reporting return of missed menses within 10 days of initiating missed period pill regimen | Up to 10 days after administration of levonorgestrel | 
| Occurrence of treatment-emergent adverse events and/or side effects (safety and tolerability) | Proportion of participants who report adverse events and/or side effects | Up to 28 days after administration of levonorgestrel | 
| Acceptability of missed period pills | Proportion of participants who report that the missed period pill service was acceptable or highly acceptable to them | Up to 28 days after administration of levonorgestrel |