Recruiting
Phase 2

Observational Study

Sponsor:

Gynuity Health Projects

Code:

NCT03972358

Conditions

Menstrual Regulation

Eligibility Criteria

Sex: Female

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

Mifepristone

Misoprostol

Study Details

Brief summary:

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

Conditions

Menstrual Regulation

Study ID

NCT03972358

Start date

Feb 12, 2020

Status verified date

Mar, 2021

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 49

Healthy Volunteers: Accepted

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

Study Design

Enrollment

284 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Medical menstrual regulation

Mifepristone 200 mg orally on day 1.

Misoprostol 800 mcg buccally on day 2 (24 hours after mifepristone).

Interventions

Mifepristone

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

Misoprostol

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

Primary outcome measure

  • Number of participants who report that MMR was acceptable or highly acceptable during the exit interview [ Time Frame: Up to 28 days after mifepristone administration ]

Central Contacts and Locations

Central contacts

Wendy R Sheldon, PhD

212-448-1230wsheldon@gynuity.org

Locations

Carafem Health Center

Recruiting

Chevy Chase, Maryland, United States, 20815

Contacts

Melissa Grant

855-729-2272

Principal Investigator:

Melissa Grant

More Information

Sponsor

Gynuity Health Projects

Last update posted

Mar 24, 2021

Last verified

Mar, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gynuity Health Projects on 2021-03-24.