Menstrual Regulation
Conditions
Brief summary
This study will assess the acceptability and use of medical menstrual regulation among women in the United States.
Detailed 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
Interventions
DRUGMifepristone
All participants will receive 200 mg mifepristone, to be taken orally on day 1.
DRUGMisoprostol
All participants will receive 800 mcg misoprostol, to be taken buccally 24 hours after mifepristone (day 2)
Sponsors
Gynuity Health Projects
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who report that MMR was acceptable or highly acceptable during the exit interview | Up to 28 days after mifepristone administration | Acceptability of MMR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants not pregnant at follow-up | Up to 28 days after mifepristone administration | Efficacy |
| Number of participants with adverse events and/or side effects | 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 | Up to 28 days after mifepristone administration | Experiences, perceived advantages and disadvantages |
Countries
United States
Contacts
Primary ContactWendy R Sheldon, PhD
Outcome results
None listed