A Two-Part Study of the Treatment of Atypical Endometrial Hyperplasia: Part A: A Prospective Study of Immediate Hysterectomy; Part B: A Randomized Phase II Study of Medroxyprogesterone Acetate Versus Depoprovera

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed atypical endometrial hyperplasia with recommended treatment
with either:

- An immediate hysterectomy (Part A) OR

- A three-month delay prior to hysterectomy and a randomized choice of treatment
with oral medroxyprogesterone acetate (Provera) or medroxyprogesterone acetate
suspension (Depo-Provera) during the 3 months (Part B with arms I and II)

- Diagnosed by dilation and curettage, Novak curettage, Vabra aspirate or Pipelle
endometrial biopsy

- No recognized endometrial carcinoma

- Must not be considered inoperable

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

- Granulocyte count at least 1,500/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal

- Alkaline phosphatase no greater than 3 times normal

Renal:

- Creatinine no greater than 2 times normal

Cardiovascular

- No prior thrombophlebitis or thromboembolic phenomena

- No prior cerebrovascular disorders

Other:

- No prior or concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ
of the uterine cervix

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- See Disease Characteristics

Radiotherapy:

- Not specified

Surgery:

- See Disease Characteristics