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Hormone Therapy

Letrozole + Misoprostol for Miscarriage (LeMi Trial)

Phase 2
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Be older than 18 years old
Must not have
Contraindication of allergy to letrozole or misoprostol
Unable to return for clinic-based follow-up
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 2 (days 10-11)
Awards & highlights

Summary

This trial is looking at whether giving a specific medication for a few days before another medication can help in managing early pregnancy loss. Researchers will monitor the effectiveness of this treatment, any side effects, and how

Who is the study for?
This trial is for English-speaking adults over 18 who have had an early pregnancy loss, as confirmed by ultrasound. Participants must be willing to follow the study's procedures, have a working mobile phone, and can sign a consent form. It's not for those with incomplete abortion, allergies to the drugs being tested, unable to return for follow-up, or having multiple pregnancies.
What is being tested?
The study tests if taking letrozole (10 mg daily) for three days before using misoprostol (800 mcg vaginally) helps manage early pregnancy loss. Researchers will check how well this works and note any additional treatments needed, side effects or adverse events.
What are the potential side effects?
Possible side effects from letrozole may include hot flashes, joint pain and fatigue; while misoprostol could cause cramping, bleeding or gastrointestinal issues like nausea and diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not allergic to letrozole or misoprostol.
Select...
I cannot come back to the clinic for follow-up visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2 (days 10-11)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 2 (days 10-11) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment Efficacy
Secondary study objectives
Acceptability

Trial Design

1Treatment groups
Experimental Treatment
Group I: Letrozole & MisprostolExperimental Treatment2 Interventions
Letrozole 10 mg orally daily for three consecutive days followed by misoprostol 800 mcg vaginally within 24 hours of final letrozole dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
2002
Completed Phase 4
~3590
Misoprostol
2008
Completed Phase 4
~3340

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,053 Previous Clinical Trials
43,013,097 Total Patients Enrolled
~20 spots leftby Jul 2025
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