Assessing Medical Menstrual Regulation in the United States

Menstrual Regulation Clinical Trial

Official title:

Assessing Acceptability and Use of Medical Menstrual Regulation in the United States

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03972358
• Other study ID #: 8002
• Status: Recruiting
• Phase: Phase 2
• Start date: February 12, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Gynuity Health Projects
• Contact: Wendy R Sheldon, PhD
• Phone: 212-448-1230
• Email: wsheldon[@]gynuity.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 284
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Menstrual Regulation

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
United States	Carafem Health Center	Chevy Chase	Maryland
United States	Carafem Health Center	Skokie	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who report that MMR was acceptable or highly acceptable during the exit interview	Acceptability of MMR	Up to 28 days after mifepristone administration
Secondary	Number of participants not pregnant at follow-up	Efficacy	Up to 28 days after mifepristone administration
Secondary	Number of participants with adverse events and/or side effects	Safety and side effects	Up to 28 days after mifepristone administration
Secondary	Perceived advantages and disadvantages of MMR as reported by participants during the exit interview	Experiences, perceived advantages and disadvantages	Up to 28 days after mifepristone administration