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Androgen Effects in HIV-infected Women

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: NCT00095212
Recruitment Status : Completed
First Posted : November 2, 2004
Results First Posted : March 15, 2010
Last Update Posted : April 14, 2010
Sponsor:
Collaborator:
Information provided by:

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV Infection
Interventions: Drug: 1 Transdermal Testosterone (Patch)
Drug: 2 Placebo Patch

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

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:  
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 ( U.S. NIH Grant/Contract )
First Submitted: November 1, 2004
First Posted: November 2, 2004
Results First Submitted: January 21, 2010
Results First Posted: March 15, 2010
Last Update Posted: April 14, 2010