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

Phase 2

Completed

• Conditions: Pregnancy
• Interventions: Drug: 30 mg letrozole followed by 800 mcg misoprostol

• Registration Number: NCT05207644
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-09
• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-26
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Letrozole followed by misoprostol	30 mg letrozole followed by 800 mcg misoprostol	There is only one arm in this study.

Primary Outcome Measures

Name	Time	Method
Safety Profile of medical abortion regimen	2 weeks	To evaluate the safety profile of a user-friendly letrozole-misoprostol regimen.

Trial Locations

Locations (1)

Planned Parenthood Salt Lake Health Center; 🇺🇸 Salt Lake City, Utah, United States