Trial Outcomes & Findings for Androgen Effects in HIV-infected Women (NCT NCT00095212)

NCT ID: NCT00095212

Last Updated: 2010-04-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: Baseline (time 0) to 18 months
• Results posted on: 2010-04-14

Participant Flow

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.

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.

Participant milestones

Measure	Transdermal Testosterone (Patch) 300 micrograms applied twice a week	Placebo Patch (Identical in Appearance) placebo patch (0 micrograms of testosterone)applied twice a week
Overall Study STARTED	13	12
Overall Study COMPLETED	12	9
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Transdermal Testosterone (Patch) 300 micrograms applied twice a week	Placebo Patch (Identical in Appearance) placebo patch (0 micrograms of testosterone)applied twice a week
Overall Study Withdrawal by Subject	1	3

Baseline Characteristics

Androgen Effects in HIV-infected Women

Baseline characteristics by cohort

Measure	Transdermal Testosterone (Patch) n=13 Participants 300 micrograms applied twice a week	Placebo Patch (Identical in Appearance) n=12 Participants placebo patch (0 micrograms of testosterone)applied twice a week	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	45 years STANDARD_DEVIATION 2 • n=5 Participants	43 years STANDARD_DEVIATION 1 • n=7 Participants	44 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	12 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (time 0) to 18 months

Population: 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.

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.

Outcome measures

Measure	Transdermal Testosterone (Patch) n=13 Participants 300 micrograms applied twice a week	Placebo Patch (Identical in Appearance) n=12 Participants placebo patch (0 micrograms of testosterone)applied twice a week
Lean Body Mass	1.8 kilograms Standard Error 0.5	0.8 kilograms Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline (time 0) to 18 months

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.

Outcome measures

Measure	Transdermal Testosterone (Patch) n=13 Participants 300 micrograms applied twice a week	Placebo Patch (Identical in Appearance) n=12 Participants placebo patch (0 micrograms of testosterone)applied twice a week
Bone Mineral Density of the Hip	0.01 grams per centimeter squared Standard Error 0.01	-0.01 grams per centimeter squared Standard Error 0.01

SECONDARY outcome

Timeframe: Baseline (time 0) to 18 months

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.

Outcome measures

Measure	Transdermal Testosterone (Patch) n=13 Participants 300 micrograms applied twice a week	Placebo Patch (Identical in Appearance) n=12 Participants placebo patch (0 micrograms of testosterone)applied twice a week
Quality of Life/Depression: Becks Depression Inventory	-6.8 Units on a scale Standard Error 2.2	-1.9 Units on a scale Standard Error 3.1

SECONDARY outcome

Timeframe: Baseline (time 0) to 18 months

Population: data not available for all subjects as some did not wish to complete the questionnaire

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.

Outcome measures

Measure	Transdermal Testosterone (Patch) n=9 Participants 300 micrograms applied twice a week	Placebo Patch (Identical in Appearance) n=7 Participants placebo patch (0 micrograms of testosterone)applied twice a week
Quality of Life/Sexual Function: Brief Index of Sexual Function (BISF-W) Domain 7: Problems Affecting Sexual Function	-1.8 Units on a scale Standard Error 0.8	0.5 Units on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline (time 0) to 18 months

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.

Outcome measures

Measure	Transdermal Testosterone (Patch) n=13 Participants 300 micrograms applied twice a week	Placebo Patch (Identical in Appearance) n=12 Participants placebo patch (0 micrograms of testosterone)applied twice a week
Safety: Number of Subjects Reporting a Skin Reaction to the Patch	4 participants	1 participants

SECONDARY outcome

Timeframe: Baseline (time 0) to 18 months

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.

Outcome measures

Measure	Transdermal Testosterone (Patch) n=13 Participants 300 micrograms applied twice a week	Placebo Patch (Identical in Appearance) n=12 Participants placebo patch (0 micrograms of testosterone)applied twice a week
Safety: Number of Subjects Reporting a Change in Hair Pattern (Increased Hair on Chin, Upper Lip, Chest, Abdomen, Fore Arms, and Legs)	2 participants	4 participants

SECONDARY outcome

Timeframe: Baseline (time 0) to 18 months

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.

Outcome measures

Measure	Transdermal Testosterone (Patch) n=13 Participants 300 micrograms applied twice a week	Placebo Patch (Identical in Appearance) n=12 Participants placebo patch (0 micrograms of testosterone)applied twice a week
Safety: Number of Subjects Reporting Acne	4 participants	3 participants

SECONDARY outcome

Timeframe: Baseline (time 0) to 18 months

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.

Outcome measures

Measure	Transdermal Testosterone (Patch) n=13 Participants 300 micrograms applied twice a week	Placebo Patch (Identical in Appearance) n=12 Participants placebo patch (0 micrograms of testosterone)applied twice a week
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)	6 participants	9 participants

SECONDARY outcome

Timeframe: Baseline (time 0) to 18 months

Population: data not available for all subjects as some did not wish to complete the testing

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.

Outcome measures

Measure	Transdermal Testosterone (Patch) n=12 Participants 300 micrograms applied twice a week	Placebo Patch (Identical in Appearance) n=7 Participants placebo patch (0 micrograms of testosterone)applied twice a week
Neurocognitive Function: Hopkins Verbal Learning Test-revised,"Total Recall" Z Score Represents Change in Z Score From Baseline to 18 Months.	-0.21 Units on a scale Standard Error 0.41	0.50 Units on a scale Standard Error 0.37

SECONDARY outcome

Timeframe: Baseline (time 0) to 18 months

Population: data not available for all subjects due to malfunctioning equipment at some sessions, and some subjects did not wish to complete 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.

Outcome measures

Measure	Transdermal Testosterone (Patch) n=11 Participants 300 micrograms applied twice a week	Placebo Patch (Identical in Appearance) n=8 Participants placebo patch (0 micrograms of testosterone)applied twice a week
Strength: Total Knee Flexion Performed Via Quantitative Muscle Function Testing.	28.5 kilograms Standard Error 11.0	11.0 kilograms Standard Error 4.9

SECONDARY outcome

Timeframe: Baseline (time 0) to 18 months

Population: data not available for all subjects due to malfunctioning equipment at some sessions, and some subjects did not wish to complete 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.

Outcome measures

Measure	Transdermal Testosterone (Patch) n=11 Participants 300 micrograms applied twice a week	Placebo Patch (Identical in Appearance) n=9 Participants placebo patch (0 micrograms of testosterone)applied twice a week
Strength: Total Knee Extension Performed Via Quantitative Muscle Function Testing.	28.0 kilograms Standard Error 7.6	26.9 kilograms Standard Error 10.7

Adverse Events

Transdermal Testosterone (Patch)

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo Patch (Identical in Appearance)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Transdermal Testosterone (Patch) n=13 participants at risk 300 micrograms applied twice a week	Placebo Patch (Identical in Appearance) n=12 participants at risk placebo patch (0 micrograms of testosterone)applied twice a week
Gastrointestinal disorders Appendectomy	7.7% 1/13 • Number of events 1 • 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.	0.00% 0/12 • 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.
Reproductive system and breast disorders ovarian cyst	0.00% 0/13 • 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.	8.3% 1/12 • Number of events 1 • 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.
Reproductive system and breast disorders uterine fibroid	0.00% 0/13 • 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.	8.3% 1/12 • Number of events 1 • 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.

Other adverse events

Measure	Transdermal Testosterone (Patch) n=13 participants at risk 300 micrograms applied twice a week	Placebo Patch (Identical in Appearance) n=12 participants at risk placebo patch (0 micrograms of testosterone)applied twice a week
Respiratory, thoracic and mediastinal disorders pneumonia	15.4% 2/13 • Number of events 2 • 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.	0.00% 0/12 • 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.
Musculoskeletal and connective tissue disorders arthralgia	7.7% 1/13 • Number of events 1 • 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.	8.3% 1/12 • Number of events 1 • 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.
Nervous system disorders peripheral neuropathy	7.7% 1/13 • Number of events 1 • 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.	0.00% 0/12 • 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.
Pregnancy, puerperium and perinatal conditions candidiasis of the vagina	0.00% 0/13 • 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.	8.3% 1/12 • Number of events 1 • 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.
Ear and labyrinth disorders otitis externa	0.00% 0/13 • 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.	8.3% 1/12 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders bronchitis	7.7% 1/13 • Number of events 1 • 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.	0.00% 0/12 • 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.
Infections and infestations sinusitis	7.7% 1/13 • Number of events 1 • 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.	0.00% 0/12 • 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.
Infections and infestations herpes zoster	7.7% 1/13 • Number of events 1 • 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.	0.00% 0/12 • 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.
Nervous system disorders vertigo	7.7% 1/13 • Number of events 1 • 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.	0.00% 0/12 • 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.
Psychiatric disorders insomnia	0.00% 0/13 • 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.	8.3% 1/12 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) simple renal cyst	0.00% 0/13 • 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.	8.3% 1/12 • Number of events 1 • 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.
Surgical and medical procedures excision of bunion	0.00% 0/13 • 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.	8.3% 1/12 • Number of events 1 • 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.
Surgical and medical procedures elective mammoplasty	7.7% 1/13 • Number of events 1 • 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.	0.00% 0/12 • 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.

Additional Information

Steven Grinspoon, MD

Massachusetts General Hospital

Phone: 617 724 9109

Email: sgrinspoon@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place