Assessing Use Of Mifepristone After Progestin Priming For Use As "Missed Period Pills"

Gynuity Health Projects

Status and phase

Unknown

Phase 2

Conditions

Missed Menstrual Period

Treatments

Drug: Levonorgestrel

Drug: Mifepristone

Study type

Interventional

Funder types

Other

Identifiers

NCT04676776

8005

Details and patient eligibility

About

This study will assess the effectiveness and acceptability of a 3-day missed period pill regimen.

Full 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

Enrollment

139 estimated patients

Sex

Female

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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