Clinical trial NCT03675139: MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia
Official title: Medroxyprogesterone Acetate (MPA) Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometrial Hyperplasia Without Atypia
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 471
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pathological complete response (CR) rates
timeFrame: From date of randomization until the date of CR, assessed up to 6 months
Secondary outcomes:
measure: Median time of pathological complete response (CR)
timeFrame: From date of randomization until the date of CR, assessed up to 6 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: up to 2 years after the treatment for each patient
measure: Relapse rates
timeFrame: up to 2 years after the treatment for each patient
measure: Rate of pregnancy
timeFrame: up to 2 years after the treatment for each patient
measure: Compliance
timeFrame: up to 2 years after the treatment for each patient
measure: cost
timeFrame: From date of randomization until the date of CR, assessed up to 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Obstetrics & Gynecology Hospital of Fudan University
name: Xiaojun Chen, PhD
role: STUDY_CHAIR
References: