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NCT05207644 Clinical Trial

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

Pregnancy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05207644
Other study ID # 1048
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 9, 2021
Est. completion date April 30, 2022

Study information
Verified date June 2022
Source Gynuity Health Projects
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Planned Parenthood Salt Lake Health Center Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety Profile of medical abortion regimen To evaluate the safety profile of a user-friendly letrozole-misoprostol regimen. 2 weeks
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