NCT06452719PHASE2Recruiting

Letrozole and Misoprostol for Early Pregnancy Loss Management

University of Pennsylvania

Start Date

8/22/2024

Completion Date

7/15/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Letrozole

DRUG

Misoprostol

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Conditions

Early Pregnancy LossMiscarriage in First TrimesterMiscarriage

Locations

PEACE / Penn Medicine

Philadelphia, Pennsylvania 19104

United States