Metformin Plus Megestrol Acetate as a Fertility-sparing Treatment in Patients With Atypical Endometrial Hyperplasia

• Sponsor: Fudan University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04607252
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.7
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atypical Endometrial Hyperplasia	Drug: Metformin plus Megestrol acetate; Drug: Megestrol Acetate	Phase 2/Phase 3

Detailed Description

Whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH) is still not clear. Our previous finding from subgroup analysis in a phase II randomized controlled trial showed that 39.6% of AEH patients in metformin plus megestrol acetate group achieved complete response, compared with 20.4% in group of megestrol acetate alone. This trial aim to fully testify the effect of metformin in fertility-sparing treatment for AEH patients with adequate sample size.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparing Metformin Plus Megestrol Acetate With Megestrol Acetate Alone as a Fertility-sparing Treatment in Patients With Atypical Endometrial Hyperplasia
• Actual Study Start Date: Jan 11, 2021
• Actual Primary Completion Date: Jun 3, 2021
• Actual Study Completion Date: Jun 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Metformin plus megestrol acetate Metformin 1500mg per day plus megestrol acetate 160mg per day.	Drug: Metformin plus Megestrol acetate; metformin 1500mg, per day, oral; megestrol acetate 160mg per day, oral
Active Comparator: Megestrol acetate Megestrol acetate 160mg per day.	Drug: Megestrol Acetate; megestrol acetate 160mg per day, oral

Outcome Measures

Primary Outcome Measures

1. Complete response within 16 weeks of treatment [16 weeks]

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

Secondary Outcome Measures

1. Complete response within 32 weeks of treatment [32 weeks]

   The reversion of AEH to proliferative or secretory endometrium

2. Adverse events [32 weeks]

   Adverse events during the treatment of metformin plus megestrol acetate or megestrol acetate alone

3. 2-year recurrence rate [2 years]

   recurrence rate within 2 years after the treatment

4. 2-year pregnancy rate [2 years]

   Pregnancy rate within 2 years after the treatment

5. 2-year live-birth rate [2 years]

   Live-birth rate within 2 years after the treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 18-45 years old;

2. pathologically diagnosed with AEH for the first time;

3. desire to preserve their fertility;

4. no signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS);

5. no contraindication for metformin, megestrol acetate or pregnancy;

6. no hormone or metformin treatment within 6 months before entering the trial;

7. not pregnant when participating in the trial;

8. willing to follow the trial arrangement after being fully informed of all the risks and inconveniences caused by the trial.

Exclusion Criteria:

Patients who had one or more of the following conditions:

1. allergy history or contraindications for megestrol acetate or metformin;

2. pregnant when initiating the study;

3. alcoholism, severe infection, severe chronical diseases (dysfunction of heart, liver, lung or kidney);

4. high risk of thrombosis;

5. recurrent AEH;

6. endometrial cancer;

7. other malignancy history.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Obstetrics and Gynecology Hospital, Fudan University	Shanghai	Shanghai	China	200011

Sponsors and Collaborators

• Fudan University

Investigators

• Principal Investigator: Xiaojun Chen, PHD, Obstetrics & Gynecology Hospital of Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaojun Chen, Prof.Dr, Fudan University
• ClinicalTrials.gov Identifier: NCT04607252
• Other Study ID Numbers: V01 2020-10
• First Posted: Oct 29, 2020
• Last Update Posted: Apr 5, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Endometrial Hyperplasia; Hyperplasia; Metformin; Megestrol; Megestrol Acetate

Study Results

No Results Posted as of Apr 5, 2022