MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia
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- STATUS
- Recruiting
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- End date
- Feb 25, 2024
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- participants needed
- 1112
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- sponsor
- Xiaojun Chen
Summary
To compare the efficacy of Medroxyprogesterone Acetate with dydrogesterone in patients having endometrial hyperplasia (EH) without atypia.
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.
Details
| Condition | Endometrial Hyperplasia Without Atypia |
|---|---|
| Treatment | Medroxyprogesterone Acetate, Dydrogesterone 10 mg |
| Clinical Study Identifier | NCT03675139 |
| Sponsor | Xiaojun Chen |
| Last Modified on | 20 June 2022 |
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