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Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00467259
First Posted: April 30, 2007
Last Update Posted: December 15, 2011
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):
Warner Chilcott
Results First Submitted: August 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypoactive Sexual Desire Disorder
Interventions: Drug: Testosterone Transdermal System
Drug: Placebo patch

  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
Screening began 14 May 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomized 1127 women not using concomitant estrogen & progestin (E&P) therapy. An additional 134 women using concomitant estrogen & progestin therapy were randomized. Subjects were stratified by using or not using E&P by site and then randomized 4:1 300 mcg/d TTS or placebo.

Reporting Groups
  Description
Placebo Placebo patch
Testosterone Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks

Participant Flow:   Overall Study
    Placebo   Testosterone
STARTED   251   1020 
ITT Population   251   1019 [1] 
COMPLETED   176   778 
NOT COMPLETED   75   242 
Adverse Event                24                90 
Protocol Violation                1                7 
Withdrawal by Subject                34                108 
Physician Decision                0                2 
Lost to Follow-up                14                34 
Site Closed                2                1 
[1] One subject did not take any study medication and was excluded from ITT population.



  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.
No text entered.

Reporting Groups
  Description
Placebo Placebo patch
Testosterone Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
Total Total of all reporting groups

Baseline Measures
   Placebo   Testosterone   Total 
Overall Participants Analyzed 
[Units: Participants]
 251   1020   1271 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 55.5  (4.8)   55.8  (4.9)   55.7  (4.9) 
[1] ITT Population
Age, Customized [1] 
[Units: Participants]
     
40-49 years old   21   95   116 
50-59 years old   182   700   882 
60-65 years old   39   189   228 
66 + years old   9   35   44 
[1] ITT Population
Gender 
[Units: Participants]
     
Female   251   1020   1271 
Male   0   0   0 
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
     
Hispanic or Latino   14   50   64 
Not Hispanic or Latino   237   969   1206 
Unknown or Not Reported   0   0   0 
[1] ITT Population
Race/Ethnicity, Customized [1] 
[Units: Participants]
     
Indian (American)   1   3   4 
Asian (Oriental)   3   6   9 
Black or African American   9   82   91 
Caucasian   231   920   1151 
Hispanic   1   3   4 
Indian (Asian)   0   1   1 
Latino   0   2   2 
Mexican   1   0   1 
Multi-Racial   4   1   5 
Hawaiian / Pacific Islander   0   1   1 
Spanish   1   0   1 
[1] ITT Population
Region of Enrollment 
[Units: Participants]
     
United States   251   1020   1271 


  Outcome Measures
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1.  Primary:   Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1   [ Time Frame: 52 weeks ]

2.  Secondary:   Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1   [ Time Frame: 52 weeks ]

3.  Secondary:   Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1   [ Time Frame: 52 weeks ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Grexan Wulff, Manager Regulatory Affairs
Organization: Warner Chilcott
phone: 973-442-3376
e-mail: gwulff@wcrx.com



Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00467259     History of Changes
Other Study ID Numbers: 2007004
First Submitted: April 27, 2007
First Posted: April 30, 2007
Results First Submitted: August 3, 2011
Results First Posted: December 15, 2011
Last Update Posted: December 15, 2011