Letrozole and Misoprostol for Early Pregnancy Loss Management
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- University of Pennsylvania
- Study ID
- NCT06452719
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Early Pregnancy Loss
- Miscarriage
- Miscarriage in First Trimester
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Letrozole — DRUGLetrozole 10 mg orally daily for three consecutive days
- Misoprostol — DRUGMisoprostol 800 mcg vaginally within 24 hours of final letrozole dose
Study Details
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 Dates
- Start date
- Aug 22, 2024
- Status verified
- Jul 2025
- Primary completion
- Jul 15, 2026
- Completion
- Jul 15, 2026
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Letrozole & MisprostolLetrozole 10 mg orally daily for three consecutive days followed by misoprostol 800 mcg vaginally within 24 hours of final letrozole dose
Primary Outcome Measure
Treatment Efficacy [ Time Frame: Visit 2 (Days 10-11) ]
Central Contacts
- Arden McAllister, MPH215-785-8030
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| PEACE / Penn Medicine | Philadelphia | Pennsylvania | 19104 | Arden McAllister, MPH Courtney A Schreiber, MD MPH (PRINCIPAL_INVESTIGATOR) |
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