Longitudinal Follow-up in Women With Endometrial Hyperplasia Without Atypia

NCT05292573 | Unknown Phase 3

• 1 other identifier: 107-2314-B-182A-166-MY3
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study will prospectively enroll a total of 1000 patients (200 per year) simple hyperplasia/complex hyperplasia (SH/CH) without atypia. All subjects will receive education for exercise and weight control and be randomized 1:1 to with or without metformin intervention. At the end of this 3-year project, an interim analysis will be performed. Since long-term follow-up is intended, therefore for the 4th to 6th year a new grant support will be looked for. The long-term occurrence of endometrial cancer (up to15 years) data will be acquired from national cancer registry, which permission is addressed in the informed sent.

Conditions

Female

Keywords

simple hyperplasia; Metformain

Outcome Measures

Primary Outcomes (1)

• The area under the receiver operating characteristic curve (ROC curve) (AUC) of the prediction miR panel of the 3 miRs.

  The primary endpoint of the randomized prospective study is to evaluate the ROC of the prediction miR panel of the 3 miRs.

  5 years

Secondary Outcomes (2)

• Time to progression among groups

  3 years

• Subgroup analysis in body-weight control

  3 years

Study Arms (2)

metformin group

EXPERIMENTAL

1. During the intervention period, metformin is given 500 mg tablet b.i.d. 2. We will deliver education for exercise and weight control to all eligible participants

Drug: Metformin

Observation group

NO INTERVENTION

only exercise and weight control to all eligible participants

Interventions

Metformin DRUG

During the intervention period, metformin is given 500 mg tablet b.i.d. Those who stopped taking metformin will remain in the study not counting as protocol violation.

Also known as: Uformin Tablet 500mg

metformin group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged ≧ 20 years
• Histological diagnosis of SH/CH without atypia
• Not taking Metformin for diabetes mellitus currently
• Adequate kidney function
• Provided informed consent within 3 months of diagnosis
• No previous history of breast cancer with tamoxifen use
• Willing to be followed for 5 years

You may not qualify if:

• Atypical hyperplasia or EC found within 3 months after enrollment
• History or concurrent gynecologic cancers or cervical intraepithelial neoplasia
• Pregnancy test positive
• History of intolerance to Metformin
• Family history of HNPCC

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Linkou Branch

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

CHYONG-HUEY LAI, M.D.

CONTACT

+88633281200; laich46@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: March 23, 2022
• Study Start: August 1, 2018
• Primary Completion: October 1, 2022
• Study Completion: January 29, 2026
• Last Updated: March 23, 2022

Record last verified: 2021-07

Locations

TW (1)