MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia

NCT03675139 | Completed Phase 3

• 1 other identifier: 53201014
• Study Type: interventional
• Target: 471
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometrial Hyperplasia Without Atypia

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (CR) rates

  The CR rates will be calculated after 3 and 6-month therapy based on the following formula: (Number of participants who got CR)/(All enrolled participants). The CR rates will be compared between two therapies (MPA VS dydrogesterone), also between two lesions (SH VS CH).

  From date of randomization until the date of CR, assessed up to 6 months

Secondary Outcomes (6)

• Median time of pathological complete response (CR)

  From date of randomization until the date of CR, assessed up to 6 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  up to 2 years after the treatment for each patient

• Relapse rates

  up to 2 years after the treatment for each patient

• Rate of pregnancy

  up to 2 years after the treatment for each patient

• Compliance

  up to 2 years after the treatment for each patient

Study Arms (2)

Medroxyprogesterone Acetate

EXPERIMENTAL

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.

Drug: Medroxyprogesterone Acetate

dydrogesterone

EXPERIMENTAL

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.

Drug: Dydrogesterone 10 MG

Interventions

Medroxyprogesterone Acetate DRUG

At a dosage of 10mg/day

Also known as: Provera

Medroxyprogesterone Acetate

Dydrogesterone 10 MG DRUG

At a dosage of 20 mg/day

Also known as: Duphaston

dydrogesterone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiaojun Chen: lead

Study Sites (1)

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Interventions

Medroxyprogesterone Acetate; Dydrogesterone

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienes

Study Officials

• Xiaojun Chen, PhD

  Obstetrics & Gynecology Hospital of Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 18, 2018
• Study Start: February 26, 2019
• Primary Completion: May 14, 2022
• Study Completion: May 15, 2022
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

CN (1)