Missed Menstrual Period
Conditions
Brief summary
This study will assess the effectiveness and acceptability of a 3-day missed period pill regimen.
Detailed description
Missed period pills (MPPs) are medications used for uterine evacuation among women with late menses who have not confirmed pregnancy status. Provision of MPPs could expand reproductive service options for individuals in a variety of settings. This study will collect data on the efficacy, safety, and acceptability of a 3-day missed period pill regimen among individuals with missed menses of 1-10 days
Interventions
DRUGLevonorgestrel
All participants receive 1.5 mg levonorgestrel on day 1
DRUGMifepristone
All participants receive 200 mg mifepristone on day 3
Sponsors
Cuidado Integral de la Mujer, Gineclinic, S.C.
Gynuity Health Projects
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Simon's two-stage design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of missed period pill regimen | Up to 28 days after administration of levonorgestrel | Proportion of participants not pregnant at follow-up among those who were pregnant at enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of missed period pill regimen | Up to 28 days after administration of levonorgestrel | Proportion of all enrolled participants not pregnant at follow-up (among those who were and were not pregnant at enrollment) |
| Effectiveness at inducing return of menses within 10 days | Up to 10 days after administration of levonorgestrel | Proportion of participants reporting return of missed menses within 10 days of initiating missed period pill regimen |
| Occurrence of treatment-emergent adverse events and/or side effects (safety and tolerability) | Up to 28 days after administration of levonorgestrel | Proportion of participants who report adverse events and/or side effects |
| Acceptability of missed period pills | Up to 28 days after administration of levonorgestrel | Proportion of participants who report that the missed period pill service was acceptable or highly acceptable to them |
Countries
Mexico
Contacts
Primary ContactHolly A Anger
Backup ContactManuel Bousieguez
Outcome results
None listed