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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00467259
First received: April 27, 2007
Last updated: November 10, 2011
Last verified: November 2011
Results First Received: August 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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  
Number of Participants  
[units: participants]
  251     1020     1271  
Age [1]
[units: years]
Mean ± Standard Deviation
  55.5  ± 4.8     55.8  ± 4.9     55.7  ± 4.9  
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  
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  
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  
Region of Enrollment  
[units: participants]
     
United States     251     1020     1271  
[1] ITT Population



  Outcome Measures
  Show All Outcome Measures

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
No text entered.


  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


No publications provided


Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00467259     History of Changes
Other Study ID Numbers: 2007004
Study First Received: April 27, 2007
Results First Received: August 3, 2011
Last Updated: November 10, 2011
Health Authority: United States: Food and Drug Administration