ClinicalTrials.gov
ClinicalTrials.gov Menu

Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus

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.
ClinicalTrials.gov Identifier: NCT00064025
Recruitment Status : Completed
First Posted : July 9, 2003
Results First Posted : August 15, 2014
Last Update Posted : April 11, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Endometrial Adenocarcinoma
Endometrial Adenosquamous Carcinoma
Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation
Recurrent Uterine Corpus Carcinoma
Stage I Uterine Corpus Cancer
Stage II Uterine Corpus Cancer
Stage III Uterine Corpus Cancer
Stage IV Uterine Corpus Cancer
Interventions: Other: Laboratory Biomarker Analysis
Drug: Medroxyprogesterone
Procedure: Therapeutic Conventional Surgery

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was activated on 4/12/2004 and closed to accrual on 9/2/2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Depo-Provera Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy

Participant Flow:   Overall Study
    Depo-Provera
STARTED   75 
COMPLETED   68 
NOT COMPLETED   7 
Ineligible                4 
Inevaluable                3 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Depo-Provera Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy

Baseline Measures
   Depo-Provera 
Overall Participants Analyzed 
[Units: Participants]
 		 68 
Age, Customized 
[Units: Participants]
 		 
30-39 years   1 
40-49 years   3 
50-59 years   28 
60-69 years   30 
70-79 years   3 
80-89 years   3 
Gender 
[Units: Participants]
 		 
Female   68 
Male   0 


  Outcome Measures

1.  Primary:   Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative   [ Time Frame: During the hysterectomy, which is 21-24 days after administration of depo-provera ]
  Show Outcome Measure 1

2.  Secondary:   Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression   [ Time Frame: During the hysterectomy, which is 21-24 days after administration of depo-provera ]
  Show Outcome Measure 2

3.  Secondary:   Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression   [ Time Frame: During the hysterectomy , which is 21-24 days after administration of depo-provera ]
  Show Outcome Measure 3


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jessalyn Reboy
Organization: Gynecologic Oncology Group Statistical and Data Center
phone: 716-845-7738
e-mail: reboyj@norgoncology.org



Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00064025     History of Changes
Other Study ID Numbers: GOG-0211
NCI-2012-02539 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000306440
GOG-0211 ( Other Identifier: Gynecologic Oncology Group )
GOG-0211 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2003
First Posted: July 9, 2003
Results First Submitted: January 31, 2014
Results First Posted: August 15, 2014
Last Update Posted: April 11, 2016