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

Phase 2

• Conditions: Missed Menstrual Period
• Interventions: Drug: Levonorgestrel; Drug: Mifepristone

• Registration Number: NCT04676776
• Lead Sponsor: Gynuity Health Projects

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 for individuals in a variety of settings. This study will collect data on the efficacy, safety, and acceptability of a 3-day missed period pill regimen among individuals with missed menses of 1-10 days

Study Timeline

• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-21
• Study Start: 2021-01-25
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-12
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 139

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Missed period pill regimen	Levonorgestrel	1.5 mg levonorgestrel given on day 1 200 mg mifepristone given on day 3
Missed period pill regimen	Mifepristone	1.5 mg levonorgestrel given on day 1 200 mg mifepristone given on day 3

Primary Outcome Measures

Name	Time	Method
Efficacy of missed period pill regimen	Up to 28 days after administration of levonorgestrel	Proportion of participants not pregnant at follow-up among those who were pregnant at enrollment

Secondary Outcome Measures

Name	Time	Method
Effectiveness of missed period pill regimen	Up to 28 days after administration of levonorgestrel	Proportion of all enrolled participants not pregnant at follow-up (among those who were and were not pregnant at enrollment)
Effectiveness at inducing return of menses within 10 days	Up to 10 days after administration of levonorgestrel	Proportion of participants reporting return of missed menses within 10 days of initiating missed period pill regimen
Occurrence of treatment-emergent adverse events and/or side effects (safety and tolerability)	Up to 28 days after administration of levonorgestrel	Proportion of participants who report adverse events and/or side effects
Acceptability of missed period pills	Up to 28 days after administration of levonorgestrel	Proportion of participants who report that the missed period pill service was acceptable or highly acceptable to them

Trial Locations

Locations (1)

Cuidado Integral de la Mujer, Gineclinic, S.C; 🇲🇽 Mexico City, Mexico