MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia
Condition: Endometrial Hyperplasia Without Atypia
MeSH terms: Endometrial Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Medroxyprogesterone Acetate; Dydrogesterone 10 MG
Intervention type(s): Drug; Drug
Intervention description(s): At a dosage of 10mg/day; At a dosage of 20 mg/day
Other intervention name(s): Provera; Duphaston
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone; Dydrogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment