Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Gynecologic Oncology Group
With
OBJECTIVES: * 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.
Age
Any age
Sex
FEMALE
Healthy volunteers
Not accepted
