Assessing Use Of Mifepristone After Progestin Priming For Use As "Missed Period Pills"
1 other identifier
interventional
139
1 country
1
Brief Summary
This study will assess the effectiveness and acceptability of a 3-day missed period pill regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2021
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2020
CompletedFirst Posted
Study publicly available on registry
December 21, 2020
CompletedStudy Start
First participant enrolled
January 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedAugust 12, 2021
August 1, 2021
10 months
December 15, 2020
August 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of missed period pill regimen
Proportion of participants not pregnant at follow-up among those who were pregnant at enrollment
Up to 28 days after administration of levonorgestrel
Secondary Outcomes (4)
Effectiveness of missed period pill regimen
Up to 28 days after administration of levonorgestrel
Effectiveness at inducing return of menses within 10 days
Up to 10 days after administration of levonorgestrel
Occurrence of treatment-emergent adverse events and/or side effects (safety and tolerability)
Up to 28 days after administration of levonorgestrel
Acceptability of missed period pills
Up to 28 days after administration of levonorgestrel
Study Arms (1)
Missed period pill regimen
EXPERIMENTAL1.5 mg levonorgestrel given on day 1 200 mg mifepristone given on day 3
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cuidado Integral de la Mujer, Gineclinic, S.C
Mexico City, Mexico
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beverly H Winikoff, MD
Gynuity Health Projects
- STUDY DIRECTOR
Holly A Anger
Gynuity Health Projects
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2020
First Posted
December 21, 2020
Study Start
January 25, 2021
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
August 12, 2021
Record last verified: 2021-08