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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05207644

Enrollment

Registered

2022-01-26

Start date

2021-12-09

Completion date

2022-04-30

Last updated

2022-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Brief summary

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

Interventions

DRUG30 mg letrozole followed by 800 mcg misoprostol

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026