MedTrace Logo

Effect of Metformin on Endometrial Thickness in Postmenopausal Breast Cancer Patients Receiving Tamoxifen

NCT07145827 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-12

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if metformin can reduce the increase in endometrial thickness caused by tamoxifen in women with estrogen-positive breast cancer taking tamoxifen for more than 1 year. It will also learn about the safety of taking metformin with tamoxifen. The main questions it aims to answer are:

1. Does metformin decrease endometrial thickness in women receiving tamoxifen?
2. What medical problems do participants have when taking metformin with tamoxifen?

Researchers will compare tamoxifen plus metformin to tamoxifen plus placebo to see if metformin works to reduce endometrial thickness compared to placebo patients.

Participants will:

1. Take metformin daily along with tamoxifen, or take tamoxifen with placebo.
2. Acquire baseline assessment and then visit the clinic at 3 months, 6 months, 9 months and 12 months for checkups and trans abdominal ultrasound test for endometrial thickness, and to be monitored for any side effects or complications.

Conditions

Interventions

DRUG

Metfomin

Metformin Tab. 500mg twice daily for 12 months (titrated to tolerance if needed).

DRUG

tamoxifen

Standard prescribed oncological dose.

DRUG

Placebo matching Metformin

An inert, film-coated tablet identical in appearance and packaging to metformin 500 mg (same size, shape, color, coating, weight, and dosing schedule), manufactured without active ingredient using standard excipients (e.g., microcrystalline cellulose, starch/croscarmellose, povidone, magnesium stearate) and identical film coat (e.g., hypromellose, polyethylene glycol, titanium dioxide). Packaged in sealed blisters to minimize odor/taste cues. Dispensed by the investigational pharmacy per randomization; to be taken twice daily"

Sponsors & Collaborators

  • Uruk University

    lead OTHER

Principal Investigators

  • Ghasak Kais Abdulhussain, BSc, MSc, PhD (Pharmacology) · Uruk University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2025-07-01
Completion
2025-07-01

Countries

  • Iraq

Study Locations

More Related Trials

Entities

Diseases

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 NCT07145827 on ClinicalTrials.gov