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NCT Number: NCT06492889

Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens

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)

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Key information

Conditions

Pregnancy Early Pregnancy Related

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levonorgestrel

Drug

Participants in the levonorgestrel plus mifepristone group will receive one tablet of 1.5 mg levonorgestrel

Mifepristone

Drug

Participants in both groups will receive one tablet of 200 mg mifepristone

Primary outcomes

  1. Efficacy of the missed period pills regimen

    Time frame: Two weeks

    Proportion of women not pregnant at follow-up who were determined to be pregnant at enrollment

  2. Effectiveness of the missed period pills regimen

    Time frame: 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 outcomes

  1. Effectiveness at inducing return of menses within 10 days of missed menses

    Time frame: One to two weeks

    Proportion of participants who experience menstrual bleeding after taking the study medications

  2. Safety/side effects

    Time frame: Two weeks

    Incidence of side effects and complications

  3. Acceptability

    Time frame: Two weeks

    Proportion of participants who report that the missed period pills service was acceptable or highly acceptable

Study contacts

Contact information is provided by the study sponsor or research team.

Manuel Bousieguez

CONTACT

[email protected]

212-448-1230

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Cuidado Integral de la Mujer, Gineclinic, S.C.
  • Servicios de Salud Medieg, A. C

Registry information

Official study title

Randomized Trial Comparing Progestin With Mifepristone Versus Mifepristone Alone for Use as Missed Period Pills

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2024
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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