Letrozole and Misoprostol for Early Pregnancy Loss Management

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06452719

Acronym

LeMi

Enrollment

Registered

2024-06-11

Start date

2024-08-22

Completion date

2026-05-14

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Pregnancy Loss, Miscarriage, Miscarriage in First Trimester

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.

Interventions

DRUGLetrozole

Letrozole 10 mg orally daily for three consecutive days

DRUGMisoprostol

Misoprostol 800 mcg vaginally within 24 hours of final letrozole dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026