NCT07145827

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Uruk University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

• Breast Cancer
• Endometrial Hyperplasia and Endometrial Cancers

Interventions

Type	Name	Description
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"

Timeline

• Start date: 2024-01-02
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2025-08-28
• Last updated: 2025-09-12

Locations

1 site across 1 country: Iraq