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Androgen Effects in HIV-infected Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00095212
First received: November 1, 2004
Last updated: April 9, 2010
Last verified: April 2010
Results First Received: January 21, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV Infection
Interventions: Drug: 1 Transdermal Testosterone (Patch)
Drug: 2 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
Recruitment began in August, 2004 and continued through October, 2006. Subjects were recruited via poster advertisement at community health centers, hospitals, and AIDS Service Organizations, as well as newspaper advertisement and provider referral.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization at the baseline visit, each subject's doctor was contacted to confirm safety of study enrollment. Subjects age 40 and older were required to have a mammogram performed within one year of study enrollment and provide results. Eligible subjects completed a pregnancy test at each visit and were excluded for a positive test.

Reporting Groups
  Description
Transdermal Testosterone (Patch) 300 micrograms applied twice a week
Placebo Patch (Identical in Appearance) placebo patch (0 micrograms of testosterone)applied twice a week

Participant Flow:   Overall Study
    Transdermal Testosterone (Patch)     Placebo Patch (Identical in Appearance)  
STARTED     13     12  
COMPLETED     12     9  
NOT COMPLETED     1     3  
Withdrawal by Subject                 1                 3  



  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
Transdermal Testosterone (Patch) 300 micrograms applied twice a week
Placebo Patch (Identical in Appearance) placebo patch (0 micrograms of testosterone)applied twice a week
Total Total of all reporting groups

Baseline Measures
    Transdermal Testosterone (Patch)     Placebo Patch (Identical in Appearance)     Total  
Number of Participants  
[units: participants]
  13     12     25  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     13     12     25  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  45  ± 2     43  ± 1     44  ± 1  
Gender  
[units: participants]
     
Female     13     12     25  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     13     12     25  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Lean Body Mass   [ Time Frame: Baseline (time 0) to 18 months ]

2.  Secondary:   Bone Mineral Density of the Hip   [ Time Frame: Baseline (time 0) to 18 months ]

3.  Secondary:   Quality of Life/Depression: Becks Depression Inventory   [ Time Frame: Baseline (time 0) to 18 months ]

4.  Secondary:   Quality of Life/Sexual Function: Brief Index of Sexual Function (BISF-W) Domain 7: Problems Affecting Sexual Function   [ Time Frame: Baseline (time 0) to 18 months ]

5.  Secondary:   Safety: Number of Subjects Reporting a Skin Reaction to the Patch   [ Time Frame: Baseline (time 0) to 18 months ]

6.  Secondary:   Safety: Number of Subjects Reporting a Change in Hair Pattern (Increased Hair on Chin, Upper Lip, Chest, Abdomen, Fore Arms, and Legs)   [ Time Frame: Baseline (time 0) to 18 months ]

7.  Secondary:   Safety: Number of Subjects Reporting Acne   [ Time Frame: Baseline (time 0) to 18 months ]

8.  Secondary:   Safety: Number of Subjects Reporting a Change in Menstrual Status (Reported More Than One Period in 1 Month or Missed a Period During a Monthly Cycle)   [ Time Frame: Baseline (time 0) to 18 months ]

9.  Secondary:   Neurocognitive Function: Hopkins Verbal Learning Test-revised,"Total Recall" Z Score Represents Change in Z Score From Baseline to 18 Months.   [ Time Frame: Baseline (time 0) to 18 months ]

10.  Secondary:   Strength: Total Knee Flexion Performed Via Quantitative Muscle Function Testing.   [ Time Frame: Baseline (time 0) to 18 months ]

11.  Secondary:   Strength: Total Knee Extension Performed Via Quantitative Muscle Function Testing.   [ Time Frame: Baseline (time 0) to 18 months ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Steven Grinspoon, MD
Organization: Massachusetts General Hospital
phone: 617 724 9109
e-mail: sgrinspoon@partners.org


Publications of Results:

Responsible Party: Steven Grinspoon, M.D., Principal Investigator, MGH
ClinicalTrials.gov Identifier: NCT00095212     History of Changes
Other Study ID Numbers: DK54167 (completed), R01DK054167
Study First Received: November 1, 2004
Results First Received: January 21, 2010
Last Updated: April 9, 2010
Health Authority: United States: Food and Drug Administration