Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens

NCT06492889 | Not Yet Recruiting Phase 2

• 1 other identifier: 8007
• Study Type: interventional
• Target: 286
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Efficacy of the missed period pills regimen

  Proportion of women not pregnant at follow-up who were determined to be pregnant at enrollment

  Two weeks

• Effectiveness of the missed period pills regimen

  Proportion of women not pregnant at follow-up among all women enrolled, including those who were pregnant and not pregnant at enrollment

  Two weeks

Secondary Outcomes (3)

• Effectiveness at inducing return of menses within 10 days of missed menses

  One to two weeks

• Safety/side effects

  Two weeks

• Acceptability

  Two weeks

Study Arms (2)

Levonorgestrel plus mifepristone

EXPERIMENTAL

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

Drug: Levonorgestrel; Drug: Mifepristone

Placebo plus mifepristone

EXPERIMENTAL

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

Drug: Mifepristone

Interventions

Levonorgestrel DRUG

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

Levonorgestrel plus mifepristone

Mifepristone DRUG

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

Levonorgestrel plus mifepristone; Placebo plus mifepristone

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gynuity Health Projects: lead
• Cuidado Integral de la Mujer, Gineclinic, S.C.: collaborator
• Servicios de Salud Medieg, A. C: collaborator

MeSH Terms

Interventions

Levonorgestrel; Mifepristone

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrenes; Estranes

Study Officials

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Bousieguez

CONTACT

212-448-1230; mbousieguez@gynuity.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: July 22, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07