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

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

Study Overview

• Status: Recruiting
• Conditions: Missed Menstrual Period
• Intervention / Treatment: Drug: Levonorgestrel; Drug: Mifepristone

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 Type: Interventional
• Enrollment (Anticipated): 139
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Holly A Anger; Phone Number: 2124481230; Email: hanger@gynuity.org
• Study Contact Backup: Name: Manuel Bousieguez; Phone Number: 2124481230; Email: mbousieguez@gynuity.org

Study Locations

• Mexico
  • Mexico City, Mexico
    • Recruiting
    • Cuidado Integral de la Mujer, Gineclinic, S.C
    • Contact: Karla Figueroa Flores, MD
    • Principal Investigator: Karla Figueroa Flores, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Missed period pill regimen; 1.5 mg levonorgestrel given on day 1 200 mg mifepristone given on day 3	Drug: Levonorgestrel; All participants receive 1.5 mg levonorgestrel on day 1; Drug: Mifepristone; All participants receive 200 mg mifepristone on day 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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	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	Up to 28 days after administration of levonorgestrel

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: Cuidado Integral de la Mujer, Gineclinic, S.C.
• Investigators: Principal Investigator: Beverly H Winikoff, MD, Gynuity Health Projects; Study Director: Holly A Anger, Gynuity Health Projects

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Abortifacient Agents; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Levonorgestrel; Mifepristone
• Other Study ID Numbers: 8005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No