Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens

Gynuity Health Projects

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Pregnancy Related; Pregnancy Early

Treatments: Drug: Mifepristone; Drug: Levonorgestrel

Study type: Interventional

Funder types: Other

Identifiers

NCT06492889

8007 (Registry Identifier)

Details and patient eligibility

About

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)

Enrollment: 286 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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286 participants in 2 patient groups

Levonorgestrel plus mifepristone

Experimental group

Description:

Women randomized to take one pill containing 1.5 mg levonorgestrel followed one to two days later by 200 mg mifepristone.

Treatment:

Drug: Levonorgestrel

Drug: Mifepristone

Placebo plus mifepristone

Experimental group

Description:

Women randomized to take one placebo pill followed one to two days later by 200 mg mifepristone.

Treatment:

Drug: Mifepristone