Trial Outcomes & Findings for Hormone and Information Processing Study (NCT NCT00539305)

NCT ID: NCT00539305

Last Updated: 2014-07-14

Results Overview

Values represent self evaluation of vigor-activity. The scale compares t-scores of participants to published norms (range 0-100), and higher scores indicate elevated emotion in subscale. Higher t-scores in vigor-activity subscale are considered favorable. Month 3 and Month 6 values display change from baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 22 participants
• Primary outcome timeframe: Baseline, 3 and 6 months
• Results posted on: 2014-07-14

Participant Flow

Participant milestones

Measure	Treatment Group Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl testosterone gel : 50-100mg applied topically daily for six months	Placebo Group Placebo gel : applied topically daily for six months
Overall Study STARTED	10	12
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Treatment Group Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl testosterone gel : 50-100mg applied topically daily for six months	Placebo Group Placebo gel : applied topically daily for six months
Overall Study Adverse Event	1	0
Overall Study Substance Use	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Hormone and Information Processing Study

Baseline characteristics by cohort

Measure	Treatment Group n=10 Participants Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl testosterone gel : 50-100mg applied topically daily for six months	Placebo Group n=12 Participants Placebo gel : applied topically daily for six months	Total n=22 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	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	71.2 years STANDARD_DEVIATION 9.1 • n=5 Participants	70.0 years STANDARD_DEVIATION 7.7 • n=7 Participants	70.5 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	12 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 and 6 months

Population: Vigor-Activity

Values represent self evaluation of vigor-activity. The scale compares t-scores of participants to published norms (range 0-100), and higher scores indicate elevated emotion in subscale. Higher t-scores in vigor-activity subscale are considered favorable. Month 3 and Month 6 values display change from baseline.

Outcome measures

Measure	Treatment Group n=9 Participants Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl testosterone gel : 50-100mg applied topically daily for six months	Placebo Group n=10 Participants Placebo gel : applied topically daily for six months
Behavioral & Mood Measure: Profile of Mood States (POMS) Baseline	57.7 units on a scale Standard Deviation 2.2	55.5 units on a scale Standard Deviation 2.0
Behavioral & Mood Measure: Profile of Mood States (POMS) Month 3 (Change from Baseline)	-4.5 units on a scale Standard Deviation 2.8	-0.1 units on a scale Standard Deviation 2.4
Behavioral & Mood Measure: Profile of Mood States (POMS) Month 6 (Change from Baseline)	1.9 units on a scale Standard Deviation 2.7	-0.5 units on a scale Standard Deviation 2.5

PRIMARY outcome

Timeframe: Baseline, 3 and 6 months

Values represent total score in Long Delay Word List Recall. Higher score indicates higher level of functioning (range 0-15). Month 3 and Month 6 indicate change from baseline.

Outcome measures

Measure	Treatment Group n=9 Participants Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl testosterone gel : 50-100mg applied topically daily for six months	Placebo Group n=10 Participants Placebo gel : applied topically daily for six months
Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test Baseline	6.2 units on a scale Standard Deviation 1.1	4.9 units on a scale Standard Deviation 1.0
Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test Month 3 (Change from Baseline)	2.3 units on a scale Standard Deviation 0.9	0.0 units on a scale Standard Deviation 0.8
Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test Month 6 (Change from Baseline)	0.9 units on a scale Standard Deviation 0.9	1.5 units on a scale Standard Deviation 0.8

PRIMARY outcome

Timeframe: Baseline, Month 3, Month 6

Values represent self evaluation of depression (range 0-30). Higher scores indicate a more depressed mood. Month 3 and Month 6 indicate change from baseline.

Outcome measures

Measure	Treatment Group n=9 Participants Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl testosterone gel : 50-100mg applied topically daily for six months	Placebo Group n=10 Participants Placebo gel : applied topically daily for six months
Geriatric Depression Scale (GDS) Baseline	7.2 units on a scale Standard Deviation 1.3	4.1 units on a scale Standard Deviation 1.2
Geriatric Depression Scale (GDS) Month 3 (Change from Baseline)	0.7 units on a scale Standard Deviation 1.5	2.3 units on a scale Standard Deviation 1.3
Geriatric Depression Scale (GDS) Month 6 (Change from Baseline)	-2.8 units on a scale Standard Deviation 1.5	2.7 units on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: Baseline, Month 3, Month 6

Self assessment of Physical Functioning in Health Survey. Higher scores indicate a higher level of functioning (range 0-100). Month 3 and 6 values represent change from baseline in subscale.

Outcome measures

Measure	Treatment Group n=9 Participants Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl testosterone gel : 50-100mg applied topically daily for six months	Placebo Group n=10 Participants Placebo gel : applied topically daily for six months
Short-Form Health Survey (SF-36) Baseline	70.7 units on a scale Standard Deviation 10.4	85.6 units on a scale Standard Deviation 2.3
Short-Form Health Survey (SF-36) Month 3 (Change from Baseline)	15.0 units on a scale Standard Deviation 9.4	-3.8 units on a scale Standard Deviation 6.4
Short-Form Health Survey (SF-36) Month 6 (Change from Baseline)	6.4 units on a scale Standard Deviation 8.6	-5.4 units on a scale Standard Deviation 3.5

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment Group n=10 participants at risk Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl testosterone gel : 50-100mg applied topically daily for six months	Placebo Group n=12 participants at risk Placebo gel : applied topically daily for six months
General disorders PSA elevated above 4.0 ng/ml	10.0% 1/10 • Number of events 1	0.00% 0/12
General disorders Emergency room with chest pains	10.0% 1/10 • Number of events 1	0.00% 0/12

Additional Information

Monique Cherrier PhD.

University of Washington

Phone: 206-277-3594

Email: cherrier@u.washington.edu

Results disclosure agreements

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