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CompletedNCT06452719LeMiUpdated Aug 10, 2026

Letrozole and Misoprostol for Early Pregnancy Loss Management

A Phase 2 interventional study of Letrozole and Misoprostol in Early Pregnancy Loss, Miscarriage in First Trimester and Miscarriage, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Early Pregnancy Loss
  • Miscarriage in First Trimester
  • Miscarriage

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03

In context

Abortion, Spontaneous

320 studies on the registry are indexed under Abortion, Spontaneous; 53 are open to participants now.

This study's enrollment of 19 is below the median of 147 across 174 interventional studies indexed under Abortion, Spontaneous.

Browse Abortion, Spontaneous studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • 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 · Drug: Misoprostol

Interventions

  • DrugLetrozole

    Letrozole 10 mg orally daily for three consecutive days

  • DrugMisoprostol

    Misoprostol 800 mcg vaginally within 24 hours of final letrozole dose

06

What researchers measure

Primary outcomes

  1. Treatment Efficacy

    Absence of gestational sac on transvaginal ultraound

    Time frame: Visit 2 (Days 10-11)

Secondary outcomes

  1. Acceptability

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

    Time frame: 30 days

07

Study locations

1 site
  • PEACE / Penn Medicine
    Philadelphia, Pennsylvania 19104, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06452719
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Jun 11, 2024
Start date
Aug 22, 2024
Primary completion
Apr 16, 2026
Completion
May 14, 2026
Last update
Aug 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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