RecruitingPhase 2

Letrozole and Misoprostol for Early Pregnancy Loss Management

United States30 participantsStarted 2024-08-22

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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

What they're measuring

Treatment Efficacy

Timeframe: Visit 2 (Days 10-11)

Trial details

NCT IDNCT06452719

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-15

Contact for this trial

Arden McAllister, MPH

215-785-8030 arden.mcallister@pennmedicine.upenn.edu

View on ClinicalTrials.gov More Early Pregnancy Loss trials