Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma

NCT01968317 | Completed Phase 2 Results DMC

• 1 other identifier: 134119a4500
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to see if megestrol acetate plus metformin will be more effective in returning the endometrial tissue to a normal state than megestrol acetate alone in patients with endometrial atypical hyperplasia or early stage endometrial adenocarcinoma.

Conditions

Endometrial Atypical Hyperplasia; Endometrial Adenocarcinoma

Keywords

Endometrial Atypical Hyperplasia; Endometrial Adenocarcinoma; Conservative Medication

Outcome Measures

Primary Outcomes (1)

• Cumulative CR Rates Within 16 Weeks

  The primary objective was to determine whether metformin plus MA would be associated with a higher CR rate at 3 months of treatment compared with MA alone. However, for patients who eventually underwent the first and second hysteroscopies for endometrium evaluation within 16 weeks of the treatment, the cumulative CR rates within 16 weeks (16w-CR) were analysed as first end point instead of the CR rate at 3 months. Complete response was defined as the reversion of AEH/EEC to proliferative or secretory endometrium in pathology.

  16 weeks after initial treatment

Secondary Outcomes (3)

• Cumulative CR Rates Within 32 Weeks

  32 weeks after initial treatment

• Recurrence Rate

  through study completion, a median time of 33 months

• Pregnancy Rate

  through study completion, a median time of 33 months

Study Arms (2)

Megestrol acetate and metformin

EXPERIMENTAL

Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months.Then an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.

Drug: Megestrol acetate and metformin

Megestrol acetate

EXPERIMENTAL

Patients will receive megestrol acetate 160 mg by mouth daily for 3 months.Then an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.

Drug: Megestrol acetate

Interventions

Megestrol acetate and metformin DRUG

Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months.

Also known as: Megestrol acetate: Megace, Metformin: Fortamet, Glucophage

Megestrol acetate and metformin

Megestrol acetate DRUG

Patients will receive megestrol acetate 160 mg by mouth daily for 3 months.

Also known as: Megestrol acetate: Megace

Megestrol acetate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be between the ages of 18-45 years old
• Primarily have a confirmed diagnosis of endometrial atypical hyperplasia based upon D\&C or hysteroscopy
• OR primarily have a confirmed diagnosis of endometrial adenocarcinoma(G1, low tumor grade), based upon D\&C or hysteroscopy, and three MRI parameters shows there's no myometrial invasion, extension beyond corpus, or enlarged lymph nodes
• Have a desire for remaining reproductive function or uterus
• Need to be able to undergo correlative treatment and follow-up

You may not qualify if:

• Have a history of serious liver or renal dysfunction
• Have a confirmed diagnosis of malignant tumor in genital system
• Have taken oral contraceptive or other medicine for the treatment of endometrial hyperplasia in the past 6 months
• Ask for removal of the uterus or other conservative treatment
• serum CA-125 \> 35 Um/L

Sponsors & Collaborators

• Xiaojun Chen: lead
• Fudan University: collaborator
• Shanghai 6th People's Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator
• Shanghai Changning Maternity & Infant Health Hospital: collaborator

Study Sites (5)

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai Changning Maternity & Infant Health Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Endometrial Hyperplasia

Interventions

Megestrol Acetate; Metformin

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Xiaojun Chen
• Organization: Obstetrics and Gynecology Hospital of Fudan University

xiaojunchen2013@sina.com

33189900

Study Officials

• Xiaojun Chen, PhD

  Obstetrics & Gynecology Hospital of Fudan University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Secretary of the Party committee

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 24, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 14, 2021
• Results First Posted: September 13, 2021

Record last verified: 2021-09

Locations

CN (5)