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Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00483327
First Posted: June 7, 2007
Last Update Posted: June 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
New York University School of Medicine
Results First Submitted: July 30, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      31 100.0% 
Male      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      6  19.4% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      4  12.9% 
White      18  58.1% 
More than one race      0   0.0% 
Unknown or Not Reported      3   9.7% 
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
  Show All Outcome Measures

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:   09/2017  


  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
First Submitted: June 5, 2007
First Posted: June 7, 2007
Results First Submitted: July 30, 2015
Results First Posted: July 1, 2016
Last Update Posted: June 22, 2017