Metformin Plus Megestrol Acetate As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia

NCT04607252 | Terminated Phase 2

• 1 other identifier: V01 2020-10
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

To verify whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH).

Conditions

Atypical Endometrial Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Complete response within 16 weeks of treatment

  reversion of AEH The reversion of AEH to proliferative or secretory endometrium

  16 weeks

Secondary Outcomes (5)

• Complete response within 32 weeks of treatment

  32 weeks

• Adverse events

  32 weeks

• 2-year recurrence rate

  2 years

• 2-year pregnancy rate

  2 years

• 2-year live-birth rate

  2 years

Study Arms (2)

Metformin plus megestrol acetate

EXPERIMENTAL

Metformin 1500mg per day plus megestrol acetate 160mg per day.

Drug: Metformin plus Megestrol acetate

Megestrol acetate

ACTIVE COMPARATOR

Megestrol acetate 160mg per day.

Drug: Megestrol Acetate

Interventions

Metformin plus Megestrol acetate DRUG

metformin 1500mg, per day, oral; megestrol acetate 160mg per day, oral

Metformin plus megestrol acetate

Megestrol Acetate DRUG

megestrol acetate 160mg per day, oral

Megestrol acetate

Eligibility Criteria

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

You may qualify if:

• years old;
• pathologically diagnosed with AEH for the first time;
• desire to preserve their fertility;
• no signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS);
• no contraindication for metformin, megestrol acetate or pregnancy;
• no hormone or metformin treatment within 6 months before entering the trial;
• not pregnant when participating in the trial;
• willing to follow the trial arrangement after being fully informed of all the risks and inconveniences caused by the trial.

You may not qualify if:

• Patients who had one or more of the following conditions:
• allergy history or contraindications for megestrol acetate or metformin;
• pregnant when initiating the study;
• alcoholism, severe infection, severe chronical diseases (dysfunction of heart, liver, lung or kidney);
• high risk of thrombosis;
• recurrent AEH;
• endometrial cancer;
• other malignancy history.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Endometrial Hyperplasia

Interventions

Metformin; Megestrol Acetate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Xiaojun Chen, PHD

  Obstetrics & Gynecology Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 29, 2020
• Study Start: January 11, 2021
• Primary Completion: June 3, 2021
• Study Completion: June 3, 2021
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)