MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia

NCT ID: NCT03675139

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 471 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-26
• Study Completion Date: 2022-05-15

Brief Summary

To compare the efficacy of Medroxyprogesterone Acetate with dydrogesterone in patients having endometrial hyperplasia (EH) without atypia.

Detailed Description

Patients pathologically diagnosed with nonatypical simple or complex EH will be enrolled. Exclusion criteria include malignancy, liver disease or liver tumor (benign or malignant), kidney disease or kidney tumor (benign or malignant), any contradictions against progesterone, history of endometrial atypical hyperplasia or endometrial cancer, any progesterone-dependent tumors, ask for other treatment.

A detailed history including menstruation, fertility, other diseases and family history will be collected. Basic information including age, waist circumstances, hip circumstances and blood pressure will also be collected. Blood tests including fasting blood glucose (FBG), postprandial blood glucose (PBG), fasting insulin (FINS), SHBG, sex hormone levels, blood lipids, liver and kidney functions will be performed before taking progesterone orally.

All enrolled and consent informed patients will be randomized into two groups, A and B, using computer-generated random numbers. Patients in group A will orally take MPA (Medroxyprogesterone Acetate) (angonghuangtitong, Xianju pharmaceuticals, China)10mg daily from tenth day of menstruation for 15 days for 3-6months. While patients in group B will take dydrogesterone (duphaston; Abbott Healthcare Products B.V, the Netherlands) 10 mg, 2 tablets twice daily from fifth day of menstruation for 20 days for 3-6 months. Endometrial Biopsy (Pipelle) will be performed every 3 months to examine the endometrium.

Complete response (CR) is defined as the reversion of EH to proliferative or secretory endometrium; partial response (PR) is defined as regression to disordered proliferative endometrium (DPE) or simple hyperplasia without atypic (only for complex hyperplasia); no response (NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as the progression of endometrial lesions.

Another 3-month therapy will be continued if the patients get NR. The longest treatment periods will be 6 months. If the patient gets PD or NR after 6 months therapy, new options must be put.

At least 3-month maintenance therapy will be recommended for patients get CR. And all of the enrolled patients will be followed up for 2 years. All data of the therapy, reverse events, side effects, pregnancy and long-term outcomes will be collected.

Conditions

Endometrial Hyperplasia Without Atypia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Medroxyprogesterone Acetate

EH patients will take MPA (Medroxyprogesterone Acetate) 10mg daily from tenth day of menstruation for 15 days for 3months. Endometrial Biopsy (Pipelle) will be performed every 3 months to examine the endometrium. All of the findings will be recorded.

Group Type: EXPERIMENTAL

Medroxyprogesterone Acetate

Intervention Type: DRUG

At a dosage of 10mg/day

dydrogesterone

EH patients will take dydrogesterone 10 mg, 2 tablets twice daily from tenth day of menstruation for 15 days for 3-6 months. Endometrial Biopsy (Pipelle) will be performed every 3-month to examine the endometrium. All of the findings will be recorded.

Group Type: EXPERIMENTAL

Dydrogesterone 10 MG

Intervention Type: DRUG

At a dosage of 20 mg/day

Interventions

Medroxyprogesterone Acetate

At a dosage of 10mg/day

Intervention Type: DRUG

Dydrogesterone 10 MG

At a dosage of 20 mg/day

Intervention Type: DRUG

Other Intervention Names

Provera; Duphaston

Eligibility Criteria

Inclusion Criteria

• Pathologically confirmed diagnosis of endometrial hyperplasia without atypia;
• Consent informed and signed;
• Able to follow treatment and take therapy in Obstetrics and Gynecology of Fudan University

Exclusion Criteria

• Liver disease or liver tumor (benign or malignant)
• Kidney disease or kidney tumor (benign or malignant)
• Other malignancies in reproductive organs
• Breast cancer or other progesterone-dependent tumors
• History of endometrial atypical hyperplasia or endometrial cancer
• Any contradictions against progesterone
• Under treatment of progestin therapy or oral conceptive drugs one month before enrollment.
• Pregnancy or suspicion of pregnancy
• Ask for other treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Xiaojun Chen

OTHER

Sponsor Role: lead

Responsible Party

Xiaojun Chen

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiaojun Chen, PhD

Role: STUDY_CHAIR

Obstetrics & Gynecology Hospital of Fudan University

Locations

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

53201014

Identifier Type: -

Identifier Source: org_study_id