Assessing Medical Menstrual Regulation in the United States

Last updated: March 22, 2021
Sponsor: Gynuity Health Projects
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03972358
8002
  • Ages 18-49
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 284
Study Start date:
February 12, 2020
Estimated Completion Date:
December 31, 2021

Study 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

Connect with a study center

  • Carafem Health Center

    Skokie, Illinois 60076
    United States

    Site Not Available

  • Carafem Health Center

    Chevy Chase, Maryland 20815
    United States

    Active - Recruiting

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