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

Atypical Endometrial Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04607252
• Other study ID #: V01 2020-10
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: January 11, 2021
• Est. completion date: June 3, 2021

Study information

• Verified date: March 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 3, 2021
• Est. primary completion date: June 3, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atypical Endometrial Hyperplasia
• Endometrial Hyperplasia
• Hyperplasia

Intervention

Drug:
• Metformin plus Megestrol acetate
metformin 1500mg, per day, oral; megestrol acetate 160mg per day, oral
• Megestrol Acetate
megestrol acetate 160mg per day, oral

Locations

Country	Name	City	State
China	Obstetrics and Gynecology Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response within 16 weeks of treatment	reversion of AEH The reversion of AEH to proliferative or secretory endometrium	16 weeks
Secondary	Complete response within 32 weeks of treatment	The reversion of AEH to proliferative or secretory endometrium	32 weeks
Secondary	Adverse events	Adverse events during the treatment of metformin plus megestrol acetate or megestrol acetate alone	32 weeks
Secondary	2-year recurrence rate	recurrence rate within 2 years after the treatment	2 years
Secondary	2-year pregnancy rate	Pregnancy rate within 2 years after the treatment	2 years
Secondary	2-year live-birth rate	Live-birth rate within 2 years after the treatment	2 years