NCT06452719

Letrozole and Misoprostol for Early Pregnancy Loss Management

Letrozole and Misoprostol for Early Pregnancy Loss Management: A Prospective Pilot Cohort Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Pregnancy Loss
• Miscarriage in First Trimester
• Miscarriage

Interventions

Type	Name	Description
DRUG	Letrozole	Letrozole 10 mg orally daily for three consecutive days
DRUG	Misoprostol	Misoprostol 800 mcg vaginally within 24 hours of final letrozole dose

Timeline

• Start date: 2024-08-22
• Primary completion: 2026-07-15
• Completion: 2026-07-15
• First posted: 2024-06-11
• Last updated: 2025-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study