Missed Menstrual Period Clinical Trial
Official title:
Assessing Use Of Mifepristone After Progestin Priming For Use As "Missed Period Pills"
This study will assess the effectiveness and acceptability of a 3-day missed period pill regimen.
| Status | Recruiting |
| Enrollment | 139 |
| Est. completion date | December 2021 |
| Est. primary completion date | December 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 49 Years |
| Eligibility | Inclusion Criteria: - Age 18-49 years - General good health - Does not want to be pregnant - History of regular monthly menstrual cycles (±3 days) - Missed menses of 1 to 10 days as verified by report of last menstrual period - Sexual activity in the past month - Willing and able to sign consent forms - Willing to return for a follow-up visit - Willing to provide a urine sample at enrollment and at follow-up Exclusion Criteria: - Known allergies or contraindications to mifepristone - Symptoms of or risk factors for ectopic pregnancy, such as vaginal bleeding or spotting within the past week; unilateral pelvic pain or significant bilateral pelvic pain within the past week; prior ectopic pregnancy; prior permanent contraception or other tubal surgery - Current use of an IUD, contraceptive implant or injectable |
| Country | Name | City | State |
|---|---|---|---|
| Mexico | Cuidado Integral de la Mujer, Gineclinic, S.C | Mexico City |
| Lead Sponsor | Collaborator |
|---|---|
| Gynuity Health Projects | Cuidado Integral de la Mujer, Gineclinic, S.C. |
Mexico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy of missed period pill regimen | Proportion of participants not pregnant at follow-up among those who were pregnant at enrollment | Up to 28 days after administration of levonorgestrel | |
| Secondary | Effectiveness of missed period pill regimen | Proportion of all enrolled participants not pregnant at follow-up (among those who were and were not pregnant at enrollment) | Up to 28 days after administration of levonorgestrel | |
| Secondary | Effectiveness at inducing return of menses within 10 days | Proportion of participants reporting return of missed menses within 10 days of initiating missed period pill regimen | Up to 10 days after administration of levonorgestrel | |
| Secondary | Occurrence of treatment-emergent adverse events and/or side effects (safety and tolerability) | Proportion of participants who report adverse events and/or side effects | Up to 28 days after administration of levonorgestrel | |
| Secondary | Acceptability of missed period pills | Proportion of participants who report that the missed period pill service was acceptable or highly acceptable to them | Up to 28 days after administration of levonorgestrel |