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 — DRUG
    Letrozole 10 mg orally daily for three consecutive days
  • Misoprostol — DRUG
    Misoprostol 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 & Misprostol
    Letrozole 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

Locations (1)

FacilityCityStateZIPSite coordinators
PEACE / Penn MedicinePhiladelphiaPennsylvania19104
Arden McAllister, MPH
Courtney A Schreiber, MD MPH (PRINCIPAL_INVESTIGATOR)

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