MedTrace Logo

Letrozole Plus Misoprostol Versus Misoprostol Alone for Treating Women With Missed Miscarriage

NCT07160855 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-09-08

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether adding the medicine letrozole to Misoprostol helps women have a complete abortion more often than using Misoprostol alone for the treatment of missed miscarriage (when a pregnancy has stopped developing but has not yet passed naturally).

The main questions this study aims to answer are:

1. Does taking letrozole for 3 days before misoprostol increase the chance of a complete abortion compared to misoprostol alone?
2. Does the use of letrozole affect the time it takes for abortion to occur? Who can Join? i. Women up to 13 weeks of pregnancy (based on last menstrual period and confirmed by ultrasound) who have a missed miscarriage.

ii. Only those with a single pregnancy are eligible. iii. Women with a previous cesarean section or uterine scar are not included.

What Will Happen in the Study A total of 92 women will take part.

Participants will be randomly assigned to one of two groups:

Group A: Letrozole tablets once daily for 3 days, followed by one dose of vaginal misoprostol.

Group B: Placebo tablets for maximum of 3 days, followed by one dose of vaginal misoprostol.

Doctors will monitor whether the abortion is complete within 24 hours. If it is not, other medical procedures will be offered as needed.

Products of conception will be examined to confirm abortion.

Conditions

  • Miscarriage in First Trimester
  • Missed Miscarriage

Interventions

DRUG

Misoprostol (given vaginally)

800 micrograms of a single dose of vaginal misoprostol will be given

DRUG

Letrozole 5 mg

10 mg oral letrozole for 3 days will be given

DRUG

Placebo

oral placebo for three days will be given

Sponsors & Collaborators

  • Nishtar Medical University

    lead OTHER

Principal Investigators

  • Rabia R Assistant Professor, FCPS · Nishtar Medical University and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-13
Primary Completion
2025-11-12
Completion
2025-11-12

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07160855 on ClinicalTrials.gov