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

NCT07160855 | Recruiting Phase 4

• 1 other identifier: U1111-1327-5077
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does taking letrozole for 3 days before misoprostol increase the chance of a complete abortion compared to misoprostol alone?
2. 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.

Conditions

Miscarriage in First Trimester; Missed Miscarriage

Keywords

Abortion, missed; Abortion, induced; Letrozole; Misoprostol; first trimester

Outcome Measures

Primary Outcomes (1)

• Complete abortion

  The expulsion of both fetus and placenta without operative intervention and no retained products of conception confirmed on ultrasound.

  From start of study medication after randomization to within 24-hours

Other Outcomes (1)

• Induction-abortion interval

  From start of study medication to abortion, within 24-hours

Study Arms (2)

Misoprostol with placebo

ACTIVE COMPARATOR

Vaginal Misoprostol will be instituted after oral placebo

Drug: Misoprostol (given vaginally); Drug: Placebo

Misoprostol with Letrozole

EXPERIMENTAL

After oral letrozole, vaginal Misoprostol will be instituted

Drug: Misoprostol (given vaginally); Drug: Letrozole 5 mg

Interventions

Misoprostol (given vaginally) DRUG

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

Also known as: Cytotec, Arthrotec

Misoprostol with Letrozole; Misoprostol with placebo

Letrozole 5 mg DRUG

10 mg oral letrozole for 3 days will be given

Also known as: femara

Misoprostol with Letrozole

Placebo DRUG

oral placebo for three days will be given

Misoprostol with placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women up till 13th weeks of gestation according to last menstrual period (LMP) dates, confirmed on ultrasound
• Single intrauterine pregnancy
• Planned for termination due to missed miscarriage

You may not qualify if:

• Previous history of cesarean section
• Uterine scar due to previous procedure like myomectomy

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Nishtar Medical University and Hospital

Multan, Punjab Province, 60000, Pakistan

RECRUITING

Related Publications (1)

• Abbasalizadeh F, Sahhaf F, Sadeghi-Shabestari P, Mirza-Aghazadeh-Attari M, Naghavi-Behzad M. Comparison Between Effect of Letrozole Plus Misoprostol and Misoprostol Alone in Terminating Non-Viable First Trimester Pregnancies: A Single Blind Randomized Trial. J Family Reprod Health. 2018 Mar;12(1):27-33.

  PMID: 30647756 BACKGROUND

MeSH Terms

Conditions

Abortion, Incomplete; Abortion, Missed

Interventions

Misoprostol; Arthrotec; Letrozole

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rabia R Assistant Professor, FCPS

  Nishtar Medical University and Hospital

  STUDY CHAIR

Central Study Contacts

Afrayshum T Principal Investigator, MBBS

CONTACT

+92 3336239197; afrayshumtariq@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: May 13, 2025
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)