Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens

NCT ID: NCT06492889

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-22
• Study Completion Date: 2025-06-30

Brief Summary

The goal of this trial is to examine the efficacy and acceptability of two medication regimens at inducing a return of menses when used 2-8 days after a missed period. The first regimen consists of one dose of 1.5 mg levonorgestrel followed one to two days later by one dose of 200 mg mifepristone. The second regimen will consist of one dose of a placebo pill, followed one to two days later by one dose of 200 mg mifepristone.

The investigators will assess and compare the efficacy of both regimens (proportion of women in each group not pregnant at follow-up who were determined to be pregnant at enrollment), and the effectiveness of both regimens (proportion of all participants not pregnant at follow-up among all participants enrolled)

Conditions

Pregnancy Early; Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Levonorgestrel plus mifepristone

Women randomized to take one pill containing 1.5 mg levonorgestrel followed one to two days later by 200 mg mifepristone.

Group Type: EXPERIMENTAL

Levonorgestrel

Intervention Type: DRUG

Participants in the levonorgestrel plus mifepristone group will receive one tablet of 1.5 mg levonorgestrel

Mifepristone

Intervention Type: DRUG

Participants in both groups will receive one tablet of 200 mg mifepristone

Placebo plus mifepristone

Women randomized to take one placebo pill followed one to two days later by 200 mg mifepristone.

Group Type: EXPERIMENTAL

Mifepristone

Intervention Type: DRUG

Participants in both groups will receive one tablet of 200 mg mifepristone

Interventions

Levonorgestrel

Participants in the levonorgestrel plus mifepristone group will receive one tablet of 1.5 mg levonorgestrel

Intervention Type: DRUG

Mifepristone

Participants in both groups will receive one tablet of 200 mg mifepristone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 15-49 years
• General good health
• Does not want to be pregnant
• History of regular monthly menstrual cycles (+/- 3 days)
• Missed menses of 2 to 8 days
• Sexual activity in the past month
• Willing and able to sign consent forms
• Willing to return for a follow-up visit
• Willing to provide urine sample at enrollment and follow-up

Exclusion Criteria

• Known allergies or contraindications to either study drug
• Symptoms or risk factors for ectopic pregnancy
• Current use of an IUD, contraceptive implant or injectable

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cuidado Integral de la Mujer, Gineclinic, S.C.

UNKNOWN

Sponsor Role: collaborator

Servicios de Salud Medieg, A. C

UNKNOWN

Sponsor Role: collaborator

Gynuity Health Projects

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beverly Winikoff, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Central Contacts

Manuel Bousieguez

Role: CONTACT

mbousieguez@gynuity.org

212-448-1230

Other Identifiers

8007

Identifier Type: -

Identifier Source: org_study_id