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

Gynuity Health Projects139 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

139

Conditions

Missed Menstrual Period

Interventions

LevonorgestrelDRUG

All participants receive 1.5 mg levonorgestrel on day 1

MifepristoneDRUG

All participants receive 200 mg mifepristone on day 3

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cuidado Integral de la Mujer, Gineclinic, S.C

Mexico City, Mexico

RECRUITING

Outcomes

Primary Outcomes

Efficacy of missed period pill regimen

Proportion of participants not pregnant at follow-up among those who were pregnant at enrollment

Time frame: Up to 28 days after administration of levonorgestrel

Secondary Outcomes

Effectiveness of missed period pill regimen

Proportion of all enrolled participants not pregnant at follow-up (among those who were and were not pregnant at enrollment)

Time frame: Up to 28 days after administration of levonorgestrel

Effectiveness at inducing return of menses within 10 days

Proportion of participants reporting return of missed menses within 10 days of initiating missed period pill regimen

Time frame: Up to 10 days after administration of levonorgestrel

Occurrence of treatment-emergent adverse events and/or side effects (safety and tolerability)

Proportion of participants who report adverse events and/or side effects

Time frame: Up to 28 days after administration of levonorgestrel

Acceptability of missed period pills

Proportion of participants who report that the missed period pill service was acceptable or highly acceptable to them

Time frame: Up to 28 days after administration of levonorgestrel

Central Contacts

Holly A Anger

CONTACT

2124481230 hanger@gynuity.org

Manuel Bousieguez

CONTACT

2124481230 mbousieguez@gynuity.org

Data from ClinicalTrials.gov

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