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Completed

NCT Number: NCT06452719

Letrozole and Misoprostol for Early Pregnancy Loss Management

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.

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Key information

Conditions

Early Pregnancy Loss Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Miscarriage Miscarriage in First Trimester Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

PEACE / Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

letrozole

Drug

Letrozole 10 mg orally daily for three consecutive days

Misoprostol

Drug

Misoprostol 800 mcg vaginally within 24 hours of final letrozole dose

Primary outcomes

  1. Treatment Efficacy

    Time frame: Visit 2 (Days 10-11)

    Absence of gestational sac on transvaginal ultraound

Secondary outcomes

  1. Acceptability

    Time frame: 30 days

    Participant assessment of treatment (Positive / Neutral / Negative), Likelihood to recommend this method of treatment to a friend (Yes / No)

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: LeMi

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2024
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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