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Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens

NCT06492889 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2024-07-18

No results posted yet for this study

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

Interventions

DRUG

Levonorgestrel

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

DRUG

Mifepristone

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

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • Servicios de Salud Medieg, A. C

    collaborator UNKNOWN

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Beverly Winikoff, MD, MPH · Gynuity Health Projects

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-22
Primary Completion
2025-06-30
Completion
2025-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06492889 on ClinicalTrials.gov