Metformin for the Treatment of Endometrial Hyperplasia

Status Completed

Clinical Trial Summary

The purpose of this study is to see if metformin will be effective in making endometrial hyperplasia without atypia better by returning the tissue to a normal state.

Clinical Trial Description

This is a multi-institutional pilot clinical trial designed to estimate the response rate and safety of metformin for the treatment of simple and complex endometrial hyperplasia (EH) without atypia. Enrollment of patients will occur at UNC-Chapel Hill and Southern Pines Women's Health Center. Fifteen patients will be enrolled over the course of 1 year. Metformin will be initiated at 850 mg orally once daily, and titrated up to twice daily over a minimum of 1 months time. Treatment will last 12 weeks and then patients will undergo repeat endometrial biopsy to assess for regression or persistence of EH. ;

Study Design

Related Conditions & MeSH terms

Endometrial Hyperplasia
Endometrial Hyperplasia Without Atypia
Hyperplasia

Clinical Trial Details

NCT number	NCT01685762
Study type	Interventional
Source	UNC Lineberger Comprehensive Cancer Center
Contact
Status	Completed
Phase	Early Phase 1
Start date	January 10, 2013
Completion date	December 1, 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05378152` - Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity	N/A
Withdrawn	`NCT00123175` - Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)	Phase 1/Phase 2
Completed	`NCT02100137` - Women With Asymptomatic Endometrial Hyperplasia	N/A
Completed	`NCT00242710` - Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women	Phase 3
Not yet recruiting	`NCT04191603` - TWO DİFFERENT ELECTROSURGERY DEVICES AS MONOPOLAR HOOC AND PLASMAKINETIC BIPOLAR SPATULA EFFECTIVENESS DURING COLPOTOMY	N/A
Completed	`NCT03032848` - Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients	Phase 4
Completed	`NCT00339651` - Preliminary Study of Endometrial Hyperplasia Groundwork for a Study to Define Precursors of Endometrial Cancer
Recruiting	`NCT01234818` - Management of Endometrial Hyperplasia With a LNG-IUS: Multicenter Study: KGOG2006	Phase 2
Recruiting	`NCT04362046` - Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia	N/A
Active, not recruiting	`NCT05257057` - Frequency of Endometrial Cancer Precursors Associated With Lynch Syndrome
Completed	`NCT00883662` - Mirena Observational Program	N/A
Completed	`NCT01499602` - Efficacy of LNG-IUS for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women	N/A
Completed	`NCT01074892` - A Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia	Phase 4
Not yet recruiting	`NCT05829460` - Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia	Phase 2
Not yet recruiting	`NCT05903131` - A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia	Phase 2
Withdrawn	`NCT04897217` - Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia	Phase 3
Recruiting	`NCT03176992` - Surgicel® & Endometrial Ablation in the Management of Perimenpausal Heavy Menstrual Bleeding	Phase 2
Not yet recruiting	`NCT00919919` - Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen	Phase 2
Recruiting	`NCT03207126` - Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy?	N/A
Recruiting	`NCT03207061` - Can 3D Ultrasound be Used as an Alternative to MRI to Assess Myometrial Invasion in Endometrial Cancer?	N/A