Assessing Medical Menstrual Regulation in the United States

Gynuity Health Projects

Status and phase: Unknown; Phase 2

Conditions: Menstrual Regulation

Treatments: Drug: Misoprostol; Drug: Mifepristone

Study type: Interventional

Funder types: Other

Identifiers

NCT03972358

8002

Details and patient eligibility

About

This study will assess the acceptability and use of medical menstrual regulation among women in the United States.

Full 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

Enrollment: 284 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18-49 years
2. General good health
3. Does not want to be pregnant
4. Does not want to verify pregnancy status at the study site
5. History of regular monthly menstrual cycles
6. Missed menses of 1-21 days
7. Sexual activity in the past 2 months
8. Willing and able to sign consent forms
9. Willing to provide urine sample at enrollment
10. Willing to return for a follow-up visit

Exclusion criteria

1. Known allergies or contraindications to mifepristone and/or misoprostol
2. Symptoms of or risk factors for ectopic pregnancy
3. Current use of an IUD, contraceptive implant or injectable

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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284 participants in 1 patient group

Medical menstrual regulation

Experimental group

Description:

Mifepristone 200 mg orally on day 1. Misoprostol 800 mcg buccally on day 2 (24 hours after mifepristone).

Treatment:

Drug: Misoprostol

Drug: Mifepristone