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OpenTrials
Completed

NCT Number: NCT05207644

Letrozole and Misoprostol for Termination of Pregnancy up to 63 Days' Gestation

Study to determine if a user-friendly medical abortion regimen using letrozole and misoprostol is safe and acceptable.

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Key information

Conditions

Pregnancy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Planned Parenthood Salt Lake Health Center

Salt Lake City, Utah, 84102, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnancy ≤ 63 days gestational age by ultrasound seeking termination of pregnancy
  • Pregnancy visible on ultrasound
  • Speaks English or Spanish
  • Willing and able to return for follow-up appointment

Exclusion criteria

  • People with gestations > 63 days gestational age
  • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
  • Pregnancy of unknown location
  • IUD or contraceptive implant in place
  • History of allergy to letrozole or misoprostol
  • Unable to return for clinic-based follow-up
  • Currently breastfeeding
  • Twin or multiple pregnancy
  • History of liver disease or abnormal liver function

Treatment and study plan

30 mg letrozole followed by 800 mcg misoprostol

Drug

30 mg letrozole on day 1 followed by 800 mcg misoprostol on day 3

Primary outcomes

  1. Safety Profile of medical abortion regimen

    Time frame: 2 weeks

    To evaluate the safety profile of a user-friendly letrozole-misoprostol regimen.

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

Letrozole and Misoprostol for Termination of Pregnancy up to 63 Days' Gestation: A Pilot Study to Evaluate the Safety and Acceptably of a User-friendly Regimen

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2022
Registry last updated
Jun 15, 2022

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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