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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

Phase 2
Not Enrolling
Endometrial Cancer

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Trial Information

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


- Determine the joint occurrence of atypical hyperplasia and adenocarcinoma in patients
diagnosed at initial biopsy to have complex atypical hyperplasia.

- Compare the histologic response rates in patients with atypical endometrial hyperplasia
treated with oral medroxyprogesterone acetate (Provera) vs intramuscular
medroxyprogesterone acetate suspension (Depo-Provera) .

OUTLINE: This is a randomized, two-part study.

- Part A: Patients undergo immediate hysterectomy.

- Part B: Patients are randomized to 1 of 2 arms.

- Arm I: Patients receive oral medroxyprogesterone acetate (Provera) once daily for
3 months.

- Arm II: Patients receive medroxyprogesterone acetate suspension (Depo- Provera)
intramuscularly once monthly for 3 months (days 1, 31, and 62).

Patients undergo hysterectomy at the end of the third month.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A minimum of 360 patients for part A and 140 patients (70 per arm) for
part B will be accrued for this study.

Inclusion Criteria


- 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



- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified


- WBC at least 3,000/mm^3

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

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


- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal

- Alkaline phosphatase no greater than 3 times normal


- Creatinine no greater than 2 times normal


- No prior thrombophlebitis or thromboembolic phenomena

- No prior cerebrovascular disorders


- 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


Biologic therapy:

- Not specified


- Not specified

Endocrine therapy:

- See Disease Characteristics


- Not specified


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Principal Investigator

John P. Curtin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

November 1998

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • endometrial cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Endometrial Hyperplasia
  • Adenoma



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