Pregnancy Early, Pregnancy Related
Conditions
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)
Interventions
DRUGLevonorgestrel
Participants in the levonorgestrel plus mifepristone group will receive one tablet of 1.5 mg levonorgestrel
DRUGMifepristone
Participants in both groups will receive one tablet of 200 mg mifepristone
Sponsors
Cuidado Integral de la Mujer, Gineclinic, S.C.
Servicios de Salud Medieg, A. C
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Known allergies or contraindications to either study drug * Symptoms or risk factors for ectopic pregnancy * Current use of an IUD, contraceptive implant or injectable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the missed period pills regimen | Two weeks | Proportion of women not pregnant at follow-up who were determined to be pregnant at enrollment |
| Effectiveness of the missed period pills regimen | Two weeks | Proportion of women not pregnant at follow-up among all women enrolled, including those who were pregnant and not pregnant at enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness at inducing return of menses within 10 days of missed menses | One to two weeks | Proportion of participants who experience menstrual bleeding after taking the study medications |
| Safety/side effects | Two weeks | Incidence of side effects and complications |
| Acceptability | Two weeks | Proportion of participants who report that the missed period pills service was acceptable or highly acceptable |
Contacts
Primary ContactManuel Bousieguez
Outcome results
None listed