Letrozole and Misoprostol for Early Pregnancy Loss Management

NCT06452719 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 855835
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Treatment Efficacy

  Absence of gestational sac on transvaginal ultraound

  Visit 2 (Days 10-11)

Secondary Outcomes (1)

• Acceptability

  30 days

Study Arms (1)

Letrozole & Misprostol

EXPERIMENTAL

Letrozole 10 mg orally daily for three consecutive days followed by misoprostol 800 mcg vaginally within 24 hours of final letrozole dose

Drug: Letrozole; Drug: Misoprostol

Interventions

Letrozole DRUG

Letrozole 10 mg orally daily for three consecutive days

Letrozole & Misprostol

Misoprostol DRUG

Misoprostol 800 mcg vaginally within 24 hours of final letrozole dose

Letrozole & Misprostol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to participate in the informed consent process and provide a signed and dated consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Access to working mobile phone
• English-speaking
• Age 18 years or older
• Confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation (ultrasound examination demonstrates a fetal pole without cardiac activity measuring between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy failure)

You may not qualify if:

• Incomplete or inevitable abortion
• Contraindication of allergy to letrozole or misoprostol
• Unable to return for clinic-based follow-up
• Twin or multiple pregnancy

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

PEACE / Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Letrozole; Misoprostol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Arden McAllister, MPH

CONTACT

215-785-8030; arden.mcallister@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: August 22, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)