Actively Recruiting
Letrozole and Misoprostol for Early Pregnancy Loss Management: A Prospective Pilot Cohort Study
Led by University of Pennsylvania · Updated on 2025-08-05
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of a treatment combining letrozole and misoprostol for managing early pregnancy loss, including miscarriage in the first trimester. The study is a Phase 2 pilot cohort trial conducted in a US population to gather preliminary data on how well this treatment works, as well as its safety and patient acceptance. Participants will receive letrozole at a dose of 10 mg taken orally once daily for three consecutive days. Within 24 hours after the last dose of letrozole, they will use 800 mcg of misoprostol administered vaginally. This treatment regimen is being studied to understand its efficacy and any additional interventions that may be needed. During the study, participants will be monitored for treatment success around 10 to 11 days after starting the intervention. Researchers will also assess side effects, adverse events, and how acceptable the treatment is to patients over a 30-day period. The study includes follow-up visits to evaluate these outcomes and ensure participant safety throughout the trial.
CONDITIONS
Brief Title
Letrozole and Misoprostol for Early Pregnancy Loss Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to participate in the informed consent process and provide a signed and dated consent form
- Willing to comply with all study procedures and available for the duration of the study
- Access to a working mobile phone
- English-speaking
- Age 18 years or older
- Confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation by ultrasound showing a fetal pole without cardiac activity measuring between 5.3 and 40 mm or abnormal growth pattern diagnostic of early pregnancy failure
You will not qualify if you...
- Incomplete or inevitable abortion
- Allergy or contraindication to letrozole or misoprostol
- Unable to return for clinic-based follow-up
- Twin or multiple pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 days
Participants take letrozole orally once daily for three consecutive days followed by a vaginal dose of misoprostol within 24 hours after the last letrozole dose.
1 baseline visit and 1 follow-up visit
Duration - 30 days
Participants are monitored for treatment efficacy and acceptability after treatment administration.
1 visit at Days 10-11 and 1 visit at 30 days
Trial Site Locations
Total: 1 location
1
PEACE / Penn Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
A
Arden McAllister, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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