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

Miscarriage Clinical Trial

— LeMi  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452719
• Other study ID #: 855835
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 15, 2024
• Est. completion date: July 15, 2025

Study information

• Verified date: June 2024
• Source: University of Pennsylvania
• Contact: Arden McAllister, MPH
• Phone: 215-785-8030
• Email: arden.mcallister[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 15, 2025
• Est. primary completion date: July 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Early Pregnancy Loss
• Fetal Death
• Miscarriage
• Miscarriage in First Trimester

Intervention

Drug:
• Letrozole
Letrozole 10 mg orally daily for three consecutive days
• Misoprostol
Misoprostol 800 mcg vaginally within 24 hours of final letrozole dose

Locations

Country	Name	City	State
United States	PEACE / Penn Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Efficacy	Absence of gestational sac on transvaginal ultraound	Visit 2 (Days 10-11)
Secondary	Acceptability	Participant assessment of treatment (Positive / Neutral / Negative), Likelihood to recommend this method of treatment to a friend (Yes / No)	30 days