Letrozole and Misoprostol for Early Pregnancy Loss Management

NCT ID: NCT06452719

Last Updated: 2025-08-05

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

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-22

Study Completion Date

2026-07-15

Brief Summary

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A pilot cohort study to preliminarily investigate the efficacy of pretreatment with letrozole 10 mg daily for three consecutive days followed by treatment with misoprostol 800 mcg vaginally for medical management of early pregnancy loss in a US population. Patients will be followed to assess efficacy of this treatment regimen, as well as additional interventions needed, side effects, adverse events, and patient acceptability.

Detailed Description

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Conditions

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Early Pregnancy Loss Miscarriage in First Trimester Miscarriage

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 & Misprostol

Letrozole 10 mg orally daily for three consecutive days followed by misoprostol 800 mcg vaginally within 24 hours of final letrozole dose

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

Letrozole 10 mg orally daily for three consecutive days

Misoprostol

Intervention Type DRUG

Misoprostol 800 mcg vaginally within 24 hours of final letrozole dose

Interventions

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Letrozole

Letrozole 10 mg orally daily for three consecutive days

Intervention Type DRUG

Misoprostol

Misoprostol 800 mcg vaginally within 24 hours of final letrozole dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Able to participate in the informed consent process and provide a signed and dated consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Access to working mobile phone
* English-speaking
* Age 18 years or older
* Confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation (ultrasound examination demonstrates a fetal pole without cardiac activity measuring between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy failure)

Exclusion Criteria

* Incomplete or inevitable abortion
* Contraindication of allergy to letrozole or misoprostol
* Unable to return for clinic-based follow-up
* Twin or multiple pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PEACE / Penn Medicine

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Arden McAllister, MPH

Role: CONTACT

215-785-8030

Facility Contacts

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Arden McAllister, MPH

Role: primary

Other Identifiers

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855835

Identifier Type: -

Identifier Source: org_study_id

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