Assessing Medical Menstrual Regulation in the United States

Gynuity Health Projects284 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

284

Conditions

Menstrual Regulation

Interventions

MifepristoneDRUG

All participants will receive 200 mg mifepristone, to be taken orally on day 1.

MisoprostolDRUG

All participants will receive 800 mcg misoprostol, to be taken buccally 24 hours after mifepristone (day 2)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Carafem Health Center

Skokie, Illinois, United States

NOT_YET_RECRUITING

Carafem Health Center

Chevy Chase, Maryland, United States

RECRUITING

Outcomes

Primary Outcomes

Number of participants who report that MMR was acceptable or highly acceptable during the exit interview

Acceptability of MMR

Time frame: Up to 28 days after mifepristone administration

Secondary Outcomes

Number of participants not pregnant at follow-up

Efficacy

Time frame: Up to 28 days after mifepristone administration

Number of participants with adverse events and/or side effects

Safety and side effects

Time frame: 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

Time frame: Up to 28 days after mifepristone administration

Central Contacts

Wendy R Sheldon, PhD

CONTACT

212-448-1230 wsheldon@gynuity.org

Data from ClinicalTrials.gov

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