Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer

This study has been terminated.
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group Identifier:
First received: November 1, 1999
Last updated: June 7, 2013
Last verified: July 2006

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of surgery with or without medroxyprogesterone may be an effective way to prevent the development of endometrial cancer in patients who have endometrial hyperplasia.

PURPOSE: Phase II trial to compare the effectiveness of surgery alone with that of medroxyprogesterone followed by surgery in preventing endometrial cancer in patients who have endometrial hyperplasia.

Condition Intervention Phase
Endometrial Cancer
Drug: medroxyprogesterone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Gynecologic Oncology Group:

Estimated Enrollment: 360
Study Start Date: November 1998
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003179

  Show 31 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: John P. Curtin, MD Memorial Sloan Kettering Cancer Center
Investigator: George L. Mutter, MD Dana-Farber/Brigham and Women's Cancer Center
Investigator: Francisco A. R. Garcia, MD, MPH University of Arizona
Investigator: Richard Zaino, MD Milton S. Hershey Medical Center
  More Information

Publications: Identifier: NCT00003179     History of Changes
Other Study ID Numbers: CDR0000065999, GOG-0167
Study First Received: November 1, 1999
Last Updated: June 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
endometrial cancer

Additional relevant MeSH terms:
Medroxyprogesterone Acetate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on November 27, 2015