Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorGynuity Health Projects

About this trial

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)

Eligibility criteria

Qualifiers

Age 15-49 years

General good health

Does not want to be pregnant

History of regular monthly menstrual cycles (+/- 3 days)

Disqualifiers

Known allergies or contraindications to either study drug

Symptoms or risk factors for ectopic pregnancy

Current use of an IUD, contraceptive implant or injectable

Trial design

Treatments tested in this trial

  • Levonorgestrel
  • Mifepristone

Treatment groups

286 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Gynuity Health Projects

Lead sponsor

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

Collaborator

Servicios de Salud Medieg, A. C

Collaborator