Assessing Use Of Mifepristone After Progestin Priming For Use As "Missed Period Pills"

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will assess the effectiveness and acceptability of a 3-day missed period pill regimen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gynuity Health Projects
• Collaborator: Cuidado Integral de la Mujer, Gineclinic, S.C.
• Treatments: Levonorgestrel; Mifepristone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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