NCT00483327

Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate

Prospective Trial of Conservative Management of Atypical Endometrial Hyperplasia and Well to Moderately Differentiated Endometrial Carcinoma Using Megestrol Acetate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to study the efficacy, toxicity, and tolerability of a standard hormonal regimen of Megestrol Acetate (Megace) in the treatment of Atypical Endometrial Hyperplasia or well to moderately differentiated endometrial carcinoma.

Detailed description

The trial's objectives are to study the efficacy, defined as complete pathologic resolution of disease, of a standard hormonal regimen with the progestin Megace for the treatment of atypical endometrial hyperplasia or well or moderately differentiated endometrial carcinoma in women desiring conservative medical management of these conditions in the Women's Cancer Program at the NYU School of Medicine and at the Bellevue Gynecologic Oncology clinics. The major endpoint is pathologic complete response (pCR). For the purposes of this study, patients will be reevaluated for response every 12 weeks until complete response. Response will be assessed within 4 weeks of completion of 12 weeks of Megace, by endometrial biopsy or dilation and curettage (D\&C)/hysteroscopy. An endometrial biopsy is sufficient to document progressive, stable disease or partial response. A D\&C is necessary to confirm complete response. Patients whose disease has completely responded will discontinue treatment and be encouraged to pursue fertility. Those not desiring immediate fertility will be placed on low dose oral contraceptive pills for at least 6 months. Patients who have had either a partial response or stable disease will be recounseled and offered continued medical management or surgical therapy. Patients whose disease has progressed will be offered definitive surgical management. Those patients declining surgery will still be followed on study.

Conditions

• Atypical Endometrial Hyperplasia
• Endometrial Carcinoma

Interventions

Type	Name	Description
DRUG	Megestrol Acetate

Timeline

• Start date: 2007-06-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2007-06-07
• Last updated: 2018-04-04
• Results posted: 2016-07-01

Locations

2 sites across 1 country: United States