Health TrialsbyHealthPanel

Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens

ConditionsPregnancy EarlyPregnancy Related
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Levonorgestrel

    Drug

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

  • Mifepristone

    Drug

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

Treatment groups

286 Participants
are divided into 2 treatment groups
Group A: Levonorgestrel plus mifepristoneExperimental treatment 2 interventions
Group B: Placebo plus mifepristoneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy of the missed period pills regimen

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

Time frame
Two weeks
2

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

Time frame
Two weeks

Secondary outcomes

1

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

Proportion of participants who experience menstrual bleeding after taking the study medications

Time frame
One to two weeks
2

Safety/side effects

Incidence of side effects and complications

Time frame
Two weeks
3

Acceptability

Proportion of participants who report that the missed period pills service was acceptable or highly acceptable

Time frame
Two weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gynuity Health Projects

Lead sponsor

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

Collaborator

Servicios de Salud Medieg, A. C

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: