Status:

COMPLETED

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

Lead Sponsor:

Gynuity Health Projects

Conditions:

Pregnancy

Eligibility:

FEMALE

18-50 years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 9 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 30 2022

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT05207644

Start Date

December 9 2021

End Date

April 30 2022

Last Update

June 15 2022

Active Locations (1)

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1

Planned Parenthood Salt Lake Health Center

Salt Lake City, Utah, United States, 84102