Letrozole and Misoprostol for Early Pregnancy Loss Management

Completed · Phase 2

Conditions studied: Early Pregnancy Loss, Miscarriage in First Trimester, Miscarriage

In brief

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.

Key facts

Study ID

NCT06452719

Run by

University of Pennsylvania

People needed

19

Starts

2024-08-22

Expected to finish

2026-05-14

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

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

Where it is running

• PEACE / Penn Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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