Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00483327
First received: June 5, 2007
Last updated: July 6, 2016
Last verified: July 2016
Results First Received: July 30, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Atypical Endometrial Hyperplasia
Endometrial Carcinoma
Intervention: Drug: Megestrol Acetate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From May 2007 to April 2012, total 31 patients were recruited to the study from New York University medical center and its affiliated hospitals.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient withdrew before the start of the treatment; ony 30 patients started the treatment.

Reporting Groups
  Description
Megestrol Acetate 80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.

Participant Flow:   Overall Study
    Megestrol Acetate  
STARTED     30  
COMPLETED     20  
NOT COMPLETED     10  
Adverse Event                 1  
Withdrawal by Subject                 3  
Lost to Follow-up                 4  
Patient Non Compliance                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All the patients enrolled to the study (including one who withdrew before the start of treatment)

Reporting Groups
  Description
Megestrol Acetate 80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.

Baseline Measures
    Megestrol Acetate  
Number of Participants  
[units: participants]
  31  
Age, Customized  
[units: participants]
 
18-24 years     1  
25-34 years     12  
35-44 years     12  
45-54 years     4  
55-64 yeras     2  
Gender  
[units: participants]
 
Female     31  
Male     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     6  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     18  
More than one race     0  
Unknown or Not Reported     3  
Region of Enrollment  
[units: participants]
 
United States     31  
Histological Diagnosis  
[units: participants]
 
Atypical endometrial hyperplasia     20  
FIGO Grade 1 endometrioid carcinoma     9  
FIGO Grade 2 endometrioid carcinoma     2  



  Outcome Measures
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1.  Primary:   Best Pathologic Responses   [ Time Frame: up to 24 months ]

2.  Secondary:   Toxicity and Tolerability   [ Time Frame: up to 36 months ]

3.  Secondary:   Number of Women Who Became Pregnant   [ Time Frame: up to 3 years after the treatment for each patient ]

4.  Secondary:   Duration of Response   [ Time Frame: up to 4 years ]
Results not yet reported.   Anticipated Reporting Date:   09/2016   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Stephanie Blank, MD
Organization: Perlmutter Cancer Center at NYU Langone
phone: 212-731-5705
e-mail: stephanie.blank@nyumc.org



Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00483327     History of Changes
Other Study ID Numbers: 06-685
Study First Received: June 5, 2007
Results First Received: July 30, 2015
Last Updated: July 6, 2016
Health Authority: United States: Institutional Review Board