Letrozole and Misoprostol for Early Pregnancy Loss Management (LeMi)

Letrozole and Misoprostol for Early Pregnancy Loss Management: A Prospective Pilot Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Miscarriage; Early Pregnancy Loss; Miscarriage in First Trimester
• Intervention / Treatment: Drug: Letrozole; Drug: Misoprostol

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Arden McAllister, MPH; Phone Number: 215-785-8030; Email: arden.mcallister@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • PEACE / Penn Medicine
      • Contact: Arden McAllister, MPH
      • Principal Investigator: Courtney A Schreiber, MD MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Letrozole; Letrozole 10 mg orally daily for three consecutive days; Drug: Misoprostol; Misoprostol 800 mcg vaginally within 24 hours of final letrozole dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Efficacy	Absence of gestational sac on transvaginal ultraound	Visit 2 (Days 10-11)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Participant assessment of treatment (Positive / Neutral / Negative), Likelihood to recommend this method of treatment to a friend (Yes / No)	30 days

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Death; Abortion, Spontaneous; Fetal Death; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents; Steroid Synthesis Inhibitors; Hormone Antagonists; Estrogen Antagonists; Aromatase Inhibitors; Oxytocics; Anti-Ulcer Agents; Letrozole; Misoprostol
• Other Study ID Numbers: 855835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes