Status:
UNKNOWN
Assessing Use Of Mifepristone After Progestin Priming For Use As "Missed Period Pills"
Lead Sponsor:
Gynuity Health Projects
Collaborating Sponsors:
Cuidado Integral de la Mujer, Gineclinic, S.C.
Conditions:
Missed Menstrual Period
Eligibility:
FEMALE
18-49 years
Phase:
PHASE2
Brief Summary
This study will assess the effectiveness and acceptability of a 3-day missed period pill regimen.
Detailed Description
Missed period pills (MPPs) are medications used for uterine evacuation among women with late menses who have not confirmed pregnancy status. Provision of MPPs could expand reproductive service options...
Eligibility Criteria
Inclusion
- Age 18-49 years
- General good health
- Does not want to be pregnant
- History of regular monthly menstrual cycles (±3 days)
- Missed menses of 1 to 10 days as verified by report of last menstrual period
- Sexual activity in the past month
- Willing and able to sign consent forms
- Willing to return for a follow-up visit
- Willing to provide a urine sample at enrollment and at follow-up
Exclusion
- Known allergies or contraindications to mifepristone
- Symptoms of or risk factors for ectopic pregnancy, such as vaginal bleeding or spotting within the past week; unilateral pelvic pain or significant bilateral pelvic pain within the past week; prior ectopic pregnancy; prior permanent contraception or other tubal surgery
- Current use of an IUD, contraceptive implant or injectable
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT04676776
Start Date
January 25 2021
End Date
December 1 2021
Last Update
August 12 2021
Active Locations (1)
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1
Cuidado Integral de la Mujer, Gineclinic, S.C
Mexico City, Mexico