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

NCT ID: NCT05207644

Last Updated: 2022-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-09

Study Completion Date

2022-04-30

Brief Summary

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

Detailed Description

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Conditions

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Pregnancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Letrozole followed by misoprostol

There is only one arm in this study.

Group Type OTHER

30 mg letrozole followed by 800 mcg misoprostol

Intervention Type DRUG

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

Interventions

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30 mg letrozole followed by 800 mcg misoprostol

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tara Shochet, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Beverly Winikoff, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

David Turok, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Utah

Locations

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Planned Parenthood Salt Lake Health Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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1048

Identifier Type: -

Identifier Source: org_study_id

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