Assessing Medical Menstrual Regulation in the United States
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ClinicalTrials.gov Identifier: NCT03972358 |
Recruitment Status :
Recruiting
First Posted : June 3, 2019
Last Update Posted : March 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Menstrual Regulation | Drug: Mifepristone Drug: Misoprostol | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 284 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Assessing Acceptability and Use of Medical Menstrual Regulation in the United States |
Actual Study Start Date : | February 12, 2020 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Medical menstrual regulation
Mifepristone 200 mg orally on day 1. Misoprostol 800 mcg buccally on day 2 (24 hours after mifepristone). |
Drug: Mifepristone
All participants will receive 200 mg mifepristone, to be taken orally on day 1. Drug: Misoprostol All participants will receive 800 mcg misoprostol, to be taken buccally 24 hours after mifepristone (day 2) |
- 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 ]Acceptability of MMR
- Number of participants not pregnant at follow-up [ Time Frame: Up to 28 days after mifepristone administration ]Efficacy
- Number of participants with adverse events and/or side effects [ Time Frame: Up to 28 days after mifepristone administration ]Safety and side effects
- Perceived advantages and disadvantages of MMR as reported by participants during the exit interview [ Time Frame: Up to 28 days after mifepristone administration ]Experiences, perceived advantages and disadvantages

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Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972358
Contact: Wendy R Sheldon, PhD | 212-448-1230 | wsheldon@gynuity.org |
United States, Illinois | |
Carafem Health Center | Not yet recruiting |
Skokie, Illinois, United States, 60076 | |
Contact: Melissa Grant 855-729-2272 | |
Principal Investigator: Melissa Grant | |
United States, Maryland | |
Carafem Health Center | Recruiting |
Chevy Chase, Maryland, United States, 20815 | |
Contact: Melissa Grant 855-729-2272 | |
Principal Investigator: Melissa Grant |
Principal Investigator: | Wendy R Sheldon, PhD | Gynuity Health Projects |
Responsible Party: | Gynuity Health Projects |
ClinicalTrials.gov Identifier: | NCT03972358 |
Other Study ID Numbers: |
8002 |
First Posted: | June 3, 2019 Key Record Dates |
Last Update Posted: | March 24, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Sharing de-identified data will be considered upon individual request. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Misoprostol Mifepristone Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Oxytocics Abortifacient Agents, Steroidal Contraceptives, Oral, Synthetic |
Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Contraceptive Agents, Hormonal Menstruation-Inducing Agents |