drugset / Trial / NCT06492889
Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens
Phase 2/3
Not yet recruiting
286 enrolled
Gynuity Health Projects
Cuidado Integral de la Mujer, Gineclinic, S.C. · collabServicios de Salud Medieg, A. C · collab
RandomizedParallel-groupDouble-blindTreatment
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)
Timeline
- Start
- 2024-07-22
- Primary completion
- 2025-06-30
- Completion
- 2025-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levonorgestrel | Small molecule | 1.5 mg | — |
| Subject | Mifepristone | Small molecule | 200 mg | — |