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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK054167 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Androgen deficiency in HIV-infected women is associated with sarcopenia and may cause critical reductions in physical functioning and reduced bone density. The effects of long-term androgen therapy on lean body mass, bone density and other clinical endpoints including quality of life, functional status and neurocognitive function in HIV-infected women are not known.
We will perform an 18-month randomized, double-blinded, placebo-controlled study among relatively androgen deficient women with HIV, to determine the effects of testosterone administration on lean body mass. The administered dose will be 300 micrograms twice a week vs. identical placebo in the form of a transdermal preparation. Secondary endpoints include effects on bone density, quality of life, neurocognitive function and menstrual function. Open label administration at 300 micrograms twice a week will be initiated for 12 months in all subjects following the randomized portion of the study. Assuming a 15% dropout rate and 25 randomized patients, the probability is 80 percent that the study will detect a treatment difference at a two sided 5.000 percent significance level, if the true difference between the treatments is 2.7 kg. This is based on the assumption that the standard deviation of the response variable, lean body mass by DEXA, is 2.3 kg, as was shown by Choi et al1 over 12 weeks in HIV-infected women at the same dose of 300 ug 2x/week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Transdermal Testosterone (Patch) | Active Comparator | 300 micrograms applied twice a week |
|
| 2 Placebo Patch (identical in appearance) | Placebo Comparator | placebo patch (0 micrograms of testosterone)applied twice a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 Transdermal Testosterone (Patch) | Drug | 300 micrograms twice a week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lean Body Mass | Represents change in measure from baseline to 18 months. 18 month mean and standard error of the mean for lean body mass measured by dual energy absorptiometry (DEXA)scan. | Baseline (time 0) to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density of the Hip | Represents change in measure from baseline to 18 months. 18 month mean and standard error of the mean for bone mineral density of the hip measured by dual energy absorptiometry (DEXA)scan. | Baseline (time 0) to 18 months |
| Quality of Life/Depression: Becks Depression Inventory |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mass General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19287303 | Result | Dolan Looby SE, Collins M, Lee H, Grinspoon S. Effects of long-term testosterone administration in HIV-infected women: a randomized, placebo-controlled trial. AIDS. 2009 May 15;23(8):951-9. doi: 10.1097/QAD.0b013e3283299145. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transdermal Testosterone (Patch) | 300 micrograms applied twice a week |
| FG001 | Placebo Patch (Identical in Appearance) | placebo patch (0 micrograms of testosterone)applied twice a week |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transdermal Testosterone (Patch) | 300 micrograms applied twice a week |
| BG001 | Placebo Patch (Identical in Appearance) | placebo patch (0 micrograms of testosterone)applied twice a week |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lean Body Mass | Represents change in measure from baseline to 18 months. 18 month mean and standard error of the mean for lean body mass measured by dual energy absorptiometry (DEXA)scan. | Responses at 9 and 18 months were pooled as the post treatment repeated measures. All data were included in the analysis, including 9 month data from the 4 subjects who discontinued after the 9 month visit. | Posted | Mean | Standard Error | kilograms | Baseline (time 0) to 18 months |
|
Adverse events were collected over an 18 month period
Subjects were seen every 6 weeks at which time a physical exam was performed, and subjects reported adverse events and/or safety concerns to the investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transdermal Testosterone (Patch) | 300 micrograms applied twice a week |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendectomy | Gastrointestinal disorders | SNOMED CT | Non-systematic Assessment | Subject was admitted to the hospital with abdominal pain and underwent surgery. This event is not related to study drug or participation. This subject was receiving testosterone. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Respiratory, thoracic and mediastinal disorders | pneumonia | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Grinspoon, MD | Massachusetts General Hospital | 617 724 9109 | sgrinspoon@partners.org |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| 2 Placebo Patch |
| Drug |
Placebo patch (0 micrograms of testosterone) applied twice a week |
|
Represents change in the mean score from baseline to 18 months. Depression was evaluated with the Beck's Depression Inventory (BDI). The BDI is a 21-item self-report instrument used to assess the presence and severity of symptoms of depression. A Total score in the range of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. |
| Baseline (time 0) to 18 months |
| Quality of Life/Sexual Function: Brief Index of Sexual Function (BISF-W) Domain 7: Problems Affecting Sexual Function | Represents change in measure from baseline to 18 months. The BISF is 22 items with seven domains: Thoughts and Desires, Arousal, Frequency of Sexual Activity, Receptivity/Initiation, Pleasure, Relationship Satisfaction, and Problems Affecting Sexual Function. Data from Domain 7: Problems Affecting Sexual Function is reported. The score range for this domain is -16 to 75,a higher score indicates greater sexual function. | Baseline (time 0) to 18 months |
| Safety: Number of Subjects Reporting a Skin Reaction to the Patch | Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant. | Baseline (time 0) to 18 months |
| Safety: Number of Subjects Reporting a Change in Hair Pattern (Increased Hair on Chin, Upper Lip, Chest, Abdomen, Fore Arms, and Legs) | Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant. | Baseline (time 0) to 18 months |
| Safety: Number of Subjects Reporting Acne | Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant. | Baseline (time 0) to 18 months |
| 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) | Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant. | Baseline (time 0) to 18 months |
| Neurocognitive Function: Hopkins Verbal Learning Test-revised,"Total Recall" Z Score Represents Change in Z Score From Baseline to 18 Months. | This test assesses verbal learning and memory. Subjects are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate trials. The Total Recall Z score is calculated based on the sum of total correct responses for Trials 1,2,& 3. A Z score of 0 equals the 50 percentile, a Z score of 1 is 1 standard deviation above the mean and a Z score of -1 is 1 standard deviation below the mean. The lowest and highest T scores for the HVLT-R are ≤20 and ≥80. This correlates to lowest and highest Z scores of ≤ -3.0 and ≥3.0. A lower Z score is indicative of poor recall. | Baseline (time 0) to 18 months |
| Strength: Total Knee Flexion Performed Via Quantitative Muscle Function Testing. | Represents change in isometric force (measured in kilograms) from baseline to 18 months. Peak isometric force of total knee flexion and extension were measured on the best of 2 repetitions for which subjects held a maximum contraction for 5 seconds. | Baseline (time 0) to 18 months |
| Strength: Total Knee Extension Performed Via Quantitative Muscle Function Testing. | Represents change in isometric force (measured in kilograms) from baseline to 18 months. Peak isometric force of total knee flexion and extension were measured on the best of 2 repetitions for which subjects held a maximum contraction for 5 seconds. | Baseline (time 0) to 18 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Bone Mineral Density of the Hip | Represents change in measure from baseline to 18 months. 18 month mean and standard error of the mean for bone mineral density of the hip measured by dual energy absorptiometry (DEXA)scan. | Posted | Mean | Standard Error | grams per centimeter squared | Baseline (time 0) to 18 months |
|
|
|
|
| Secondary | Quality of Life/Depression: Becks Depression Inventory | Represents change in the mean score from baseline to 18 months. Depression was evaluated with the Beck's Depression Inventory (BDI). The BDI is a 21-item self-report instrument used to assess the presence and severity of symptoms of depression. A Total score in the range of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. | Posted | Mean | Standard Error | Units on a scale | Baseline (time 0) to 18 months |
|
|
|
|
| Secondary | Quality of Life/Sexual Function: Brief Index of Sexual Function (BISF-W) Domain 7: Problems Affecting Sexual Function | Represents change in measure from baseline to 18 months. The BISF is 22 items with seven domains: Thoughts and Desires, Arousal, Frequency of Sexual Activity, Receptivity/Initiation, Pleasure, Relationship Satisfaction, and Problems Affecting Sexual Function. Data from Domain 7: Problems Affecting Sexual Function is reported. The score range for this domain is -16 to 75,a higher score indicates greater sexual function. | data not available for all subjects as some did not wish to complete the questionnaire | Posted | Mean | Standard Error | Units on a scale | Baseline (time 0) to 18 months |
|
|
|
|
| Secondary | Safety: Number of Subjects Reporting a Skin Reaction to the Patch | Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant. | Posted | Number | participants | Baseline (time 0) to 18 months |
|
|
|
|
| Secondary | Safety: Number of Subjects Reporting a Change in Hair Pattern (Increased Hair on Chin, Upper Lip, Chest, Abdomen, Fore Arms, and Legs) | Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant. | Posted | Number | participants | Baseline (time 0) to 18 months |
|
|
|
|
| Secondary | Safety: Number of Subjects Reporting Acne | Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant. | Posted | Number | participants | Baseline (time 0) to 18 months |
|
|
|
|
| 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) | Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant. | Posted | Number | participants | Baseline (time 0) to 18 months |
|
|
|
|
| Secondary | Neurocognitive Function: Hopkins Verbal Learning Test-revised,"Total Recall" Z Score Represents Change in Z Score From Baseline to 18 Months. | This test assesses verbal learning and memory. Subjects are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate trials. The Total Recall Z score is calculated based on the sum of total correct responses for Trials 1,2,& 3. A Z score of 0 equals the 50 percentile, a Z score of 1 is 1 standard deviation above the mean and a Z score of -1 is 1 standard deviation below the mean. The lowest and highest T scores for the HVLT-R are ≤20 and ≥80. This correlates to lowest and highest Z scores of ≤ -3.0 and ≥3.0. A lower Z score is indicative of poor recall. | data not available for all subjects as some did not wish to complete the testing | Posted | Mean | Standard Error | Units on a scale | Baseline (time 0) to 18 months |
|
|
|
|
| Secondary | Strength: Total Knee Flexion Performed Via Quantitative Muscle Function Testing. | Represents change in isometric force (measured in kilograms) from baseline to 18 months. Peak isometric force of total knee flexion and extension were measured on the best of 2 repetitions for which subjects held a maximum contraction for 5 seconds. | data not available for all subjects due to malfunctioning equipment at some sessions, and some subjects did not wish to complete testing. | Posted | Mean | Standard Error | kilograms | Baseline (time 0) to 18 months |
|
|
|
|
| Secondary | Strength: Total Knee Extension Performed Via Quantitative Muscle Function Testing. | Represents change in isometric force (measured in kilograms) from baseline to 18 months. Peak isometric force of total knee flexion and extension were measured on the best of 2 repetitions for which subjects held a maximum contraction for 5 seconds. | data not available for all subjects due to malfunctioning equipment at some sessions, and some subjects did not wish to complete testing. | Posted | Mean | Standard Error | kilograms | Baseline (time 0) to 18 months |
|
|
|
|
| 1 |
| 13 |
| 9 |
| 13 |
| EG001 | Placebo Patch (Identical in Appearance) | placebo patch (0 micrograms of testosterone)applied twice a week | 1 | 12 | 6 | 12 |
|
| ovarian cyst | Reproductive system and breast disorders | SNOMED CT | Non-systematic Assessment | Subject was seen in the emergency room for discomfort and was diagnosed with an ovarian cyst and uterine fibroid. This event is not related to study participation. Subject was receiving placebo. |
|
| uterine fibroid | Reproductive system and breast disorders | SNOMED CT | Non-systematic Assessment | Subject was seen in the emergency room for discomfort and was diagnosed with an ovarian cyst and uterine fibroid. This event is not related to study participation. Subject was receiving placebo. |
|
| arthralgia | Musculoskeletal and connective tissue disorders | arthralgia | Non-systematic Assessment |
|
| peripheral neuropathy | Nervous system disorders | peripheral neuropath | Non-systematic Assessment |
|
| candidiasis of the vagina | Pregnancy, puerperium and perinatal conditions | SNOMED CT | Non-systematic Assessment |
|
| otitis externa | Ear and labyrinth disorders | otitis externa | Non-systematic Assessment |
|
| bronchitis | Respiratory, thoracic and mediastinal disorders | bronchitis | Non-systematic Assessment |
|
| sinusitis | Infections and infestations | sinusitis | Non-systematic Assessment |
|
| herpes zoster | Infections and infestations | herpes zoster | Non-systematic Assessment |
|
| vertigo | Nervous system disorders | vertigo | Non-systematic Assessment |
|
| insomnia | Psychiatric disorders | insomnia | Non-systematic Assessment |
|
| simple renal cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | simple renal cyst | Non-systematic Assessment |
|
| excision of bunion | Surgical and medical procedures | excision of bunion | Non-systematic Assessment |
|
| elective mammoplasty | Surgical and medical procedures | elective mammoplasty | Non-systematic Assessment |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |