Letrozole Plus Misoprostol Versus Misoprostol Only in Induction of Missed Abortion

Letrozole Plus Misoprostol Versus Misoprostol Only in Induction of Missed Abortion: A Randomized Controlled Trial

This study aimed to evaluate the effect of letrozole plus misoprostol to terminate non-viable pregnancies in first trimester compared with the use of misoprostol alone.

Study Overview

• Status: Completed
• Conditions: Missed Abortion; Letrozole; Misoprostol; Induction
• Intervention / Treatment: Drug: Letrozole + Misoprostol; Drug: Misoprostol

Detailed Description

Inducing abortion by drugs is an alternative for surgery intervention, which has economic benefits with lower side effects and its rate of success is 60 to 95%.

Letrozole is also one of aromatase inhibitors, which is used to stimulate ovulation in infertile women suffering ovulatory dysfunction. This drug is one of the main drugs for inhibiting aromatase, with a relatively short 45-hour half life, which is active orally and inhibits aromatase enzyme reversibly.

Misoprostol is a relatively safe drug and of its side effects it is possible to mention to gestational effects, feeling of warmth, and shivering. Severe side effects of misoprostol consumption are severe bleeding and endometritis, with less than 1% prevalence based on studies.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82511
    • Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age from 18 to 45 years.
• Women with nonviable pregnancies undergoing 1st-trimester abortion.

Exclusion Criteria:

• Medical diseases like renal or liver disease.
• Severe bleeding and shocked patients.
• Inevitable abortion.
• Hypersensitivity to any of the drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Patients received 10 mg of Letrozole daily for three days, subsequently receiving 800 µg of Misoprostol every three hours via vaginal or sublingual routes.	Drug: Letrozole + Misoprostol; Patients received 10 mg of Letrozole daily for three days, subsequently receiving 800 µg of Misoprostol every three hours via vaginal or sublingual routes.
Active Comparator: Group 2; Patients received only 800 µg of Misoprostol.	Drug: Misoprostol; Patients received only 800 µg of Misoprostol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bleeding	Incidence of bleeding was recorded.	7 days following the Misoprostol dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of dosages of prostaglandins	Number of dosages of prostaglandins was recorded.	7 days following the Misoprostol dose
Duration required for abortion	Duration required for abortion was recorded.	7 days following the Misoprostol dose
Incidence of adverse effects	Incidence of adverse effects such as nausea, vomiting, gastric distress, headache, fever, and shivers were recorded.	7 days following the Misoprostol dose

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2025
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Abortion, Spontaneous; Abortion, Missed; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Azoles; Biological Factors; Nitriles; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Triazoles; Prostaglandins E, Synthetic; Letrozole; Misoprostol
• Other Study ID Numbers: Soh-Med-24-6-8PD.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No