Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Medroxyprogesterone Acetate (MPA) Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia

ID
Name
53201014
Description
To compare the efficacy of Medroxyprogesterone Acetate with dydrogesterone in patients having endometrial hyperplasia (EH) without atypia.
Trial arms
Trial start
2019-02-26
Estimated PCD
2022-05-14
Trial end
2022-05-15
Status
Completed
Phase
Early phase I
Treatment
Medroxyprogesterone Acetate
At a dosage of 10mg/day
Arms:
Medroxyprogesterone Acetate
Other names:
Provera
Dydrogesterone 10 MG
At a dosage of 20 mg/day
Arms:
dydrogesterone
Other names:
Duphaston
Size
471
Primary endpoint
Pathological complete response (CR) rates
From date of randomization until the date of CR, assessed up to 6 months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 471, 'type': 'ACTUAL'}}
Updated at
2023-02-17

1 organization

2 products

1 indication

Organization
Xiaojun Chen
Product
Medroxyprogesterone
Indication
Endometrial Hyperplasia
Product
Dydrogesterone