Letrozole and Misoprostol for Early Pregnancy Loss Management

Phase 2

Recruiting

• Conditions: Miscarriage in First Trimester; Early Pregnancy Loss; Miscarriage
• Interventions: Drug: Letrozole; Drug: Misoprostol

• Registration Number: NCT06452719
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-05
• Study First Posted: 2024-06-11
• Status Verified: 2024-08
• Study Start: 2024-08-22
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-29
• Primary Completion: 2025-07-15
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Letrozole & Misprostol	Letrozole	Letrozole 10 mg orally daily for three consecutive days followed by misoprostol 800 mcg vaginally within 24 hours of final letrozole dose
Letrozole & Misprostol	Misoprostol	Letrozole 10 mg orally daily for three consecutive days followed by misoprostol 800 mcg vaginally within 24 hours of final letrozole dose

Primary Outcome Measures

Name	Time	Method
Treatment Efficacy	Visit 2 (Days 10-11)	Absence of gestational sac on transvaginal ultraound

Secondary Outcome Measures

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

Trial Locations

Locations (1)

PEACE / Penn Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States