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

Gynuity Health Projects

Status and phase: Completed; Phase 2

Conditions: Pregnancy

Treatments: Drug: 30 mg letrozole followed by 800 mcg misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT05207644

1048

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Letrozole followed by misoprostol

Other group

Description:

There is only one arm in this study.

Treatment:

Drug: 30 mg letrozole followed by 800 mcg misoprostol