Assessing Medical Menstrual Regulation in the United States

Study Overview
=================
Brief Summary
-----------------
This study will assess the acceptability and use of medical menstrual regulation among women in the United States.

Detailed Description
-----------------
Medical menstrual regulation (MMR) entails the use of uterine evacuation medications by women with late menses without confirming pregnancy status. Provision of MMR in the United States could expand reproductive choice and service options for women. This study will collect data on the acceptability, efficacy, safety and feasibility of MMR among women with missed menses of 1-21 days

Official Title
-----------------
Assessing Acceptability and Use of Medical Menstrual Regulation in the United States

Conditions
-----------------
Menstrual Regulation

Intervention / Treatment
-----------------
* Drug: Mifepristone
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-49 years General good health Does not want to be pregnant Does not want to verify pregnancy status at the study site History of regular monthly menstrual cycles Missed menses of 1-21 days Sexual activity in the past 2 months Willing and able to sign consent forms Willing to provide urine sample at enrollment Willing to return for a follow-up visit Exclusion Criteria: Known allergies or contraindications to mifepristone and/or misoprostol Symptoms of or risk factors for ectopic pregnancy Current use of an IUD, contraceptive implant or injectable

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

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical menstrual regulation<br>Mifepristone 200 mg orally on day 1. Misoprostol 800 mcg buccally on day 2 (24 hours after mifepristone). | Drug: Mifepristone<br>* All participants will receive 200 mg mifepristone, to be taken orally on day 1.<br>Drug: Misoprostol<br>* All participants will receive 800 mcg misoprostol, to be taken buccally 24 hours after mifepristone (day 2)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who report that MMR was acceptable or highly acceptable during the exit interview | Acceptability of MMR | Up to 28 days after mifepristone administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants not pregnant at follow-up | Efficacy | Up to 28 days after mifepristone administration | 
| Number of participants with adverse events and/or side effects | Safety and side effects | Up to 28 days after mifepristone administration | 
| Perceived advantages and disadvantages of MMR as reported by participants during the exit interview | Experiences, perceived advantages and disadvantages | Up to 28 days after mifepristone administration |