Trial Outcomes & Findings for Effect of Testosterone in Men With Erectile Dysfunction (NCT NCT00512707)
NCT ID: NCT00512707
Last Updated: 2017-06-29
Results Overview
IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with Erectile Function domain range of 1 to 30 with higher scores representing better function.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
140 participants
Primary outcome timeframe
Week 0, week 8, week 11, week 14
Results posted on
2017-06-29
Participant Flow
Participant milestones
| Measure |
Testosterone
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
60
|
58
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
| Measure |
Testosterone
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
11
|
|
Overall Study
Developed skin irritation
|
2
|
1
|
|
Overall Study
Developed a hematocrit exceeding 0.54
|
2
|
0
|
|
Overall Study
Unable to tolerate the smell of the gel
|
1
|
0
|
Baseline Characteristics
Based on the number of participants who responded.
Baseline characteristics by cohort
| Measure |
Testosterone
n=70 Participants
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
n=70 Participants
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 8.3 • n=70 Participants
|
54.6 years
STANDARD_DEVIATION 8.5 • n=70 Participants
|
54.9 years
STANDARD_DEVIATION 8.4 • n=140 Participants
|
|
Sex/Gender, Customized
Male
|
70 Participants
n=70 Participants
|
70 Participants
n=70 Participants
|
140 Participants
n=140 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
28 Participants
n=68 Participants • Based on the number of participants who responded.
|
33 Participants
n=70 Participants • Based on the number of participants who responded.
|
61 Participants
n=138 Participants • Based on the number of participants who responded.
|
|
Race/Ethnicity, Customized
Race · White
|
36 Participants
n=68 Participants • Based on the number of participants who responded.
|
32 Participants
n=70 Participants • Based on the number of participants who responded.
|
68 Participants
n=138 Participants • Based on the number of participants who responded.
|
|
Race/Ethnicity, Customized
Race · Other
|
4 Participants
n=68 Participants • Based on the number of participants who responded.
|
5 Participants
n=70 Participants • Based on the number of participants who responded.
|
9 Participants
n=138 Participants • Based on the number of participants who responded.
|
|
BMI
|
31.5 kg/m^2
STANDARD_DEVIATION 6.4 • n=70 Participants
|
32.7 kg/m^2
STANDARD_DEVIATION 6.0 • n=70 Participants
|
32.1 kg/m^2
STANDARD_DEVIATION 6.2 • n=140 Participants
|
|
Diabetes mellitus
|
13 Participants
n=70 Participants
|
14 Participants
n=70 Participants
|
27 Participants
n=140 Participants
|
|
Hypertension
|
29 Participants
n=70 Participants
|
27 Participants
n=70 Participants
|
56 Participants
n=140 Participants
|
|
Cardiovascular disease
|
35 Participants
n=70 Participants
|
32 Participants
n=70 Participants
|
67 Participants
n=140 Participants
|
|
Total testosterone level
|
248 ng/dL
STANDARD_DEVIATION 62 • n=70 Participants
|
254 ng/dL
STANDARD_DEVIATION 68 • n=70 Participants
|
251 ng/dL
STANDARD_DEVIATION 65 • n=140 Participants
|
|
Total testosterone level <250 ng/dL
|
31 Participants
n=70 Participants
|
28 Participants
n=70 Participants
|
59 Participants
n=140 Participants
|
|
Free testosterone level
|
45 pg/mL
STANDARD_DEVIATION 15 • n=70 Participants
|
47 pg/mL
STANDARD_DEVIATION 16 • n=70 Participants
|
46 pg/mL
STANDARD_DEVIATION 15 • n=140 Participants
|
|
International Index of Erectile Function (IIEF)
Erectile function
|
12.2 units on a scale
STANDARD_DEVIATION 5.9 • n=70 Participants
|
12.0 units on a scale
STANDARD_DEVIATION 6.5 • n=70 Participants
|
12.1 units on a scale
STANDARD_DEVIATION 6.2 • n=140 Participants
|
|
International Index of Erectile Function (IIEF)
Orgasmic function
|
5.1 units on a scale
STANDARD_DEVIATION 3.0 • n=70 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 3.1 • n=70 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 3.1 • n=140 Participants
|
|
International Index of Erectile Function (IIEF)
Sexual desire
|
5.6 units on a scale
STANDARD_DEVIATION 1.9 • n=70 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 1.9 • n=70 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 1.9 • n=140 Participants
|
|
International Index of Erectile Function (IIEF)
Intercourse satisfaction
|
6.1 units on a scale
STANDARD_DEVIATION 3.4 • n=70 Participants
|
6.0 units on a scale
STANDARD_DEVIATION 3.6 • n=70 Participants
|
6.0 units on a scale
STANDARD_DEVIATION 3.5 • n=140 Participants
|
|
International Index of Erectile Function (IIEF)
Overall satisfaction
|
4.3 units on a scale
STANDARD_DEVIATION 1.9 • n=70 Participants
|
4.5 units on a scale
STANDARD_DEVIATION 2.1 • n=70 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 2.0 • n=140 Participants
|
|
International Index of Erectile Function (IIEF)
Composite IIEF
|
33 units on a scale
STANDARD_DEVIATION 13 • n=70 Participants
|
33 units on a scale
STANDARD_DEVIATION 14 • n=70 Participants
|
33 units on a scale
STANDARD_DEVIATION 13 • n=140 Participants
|
|
Sexual Encounter Profile (SEP)
Sexual encounter attempts
|
2.5 events/week
STANDARD_DEVIATION 1.4 • n=70 Participants
|
2.3 events/week
STANDARD_DEVIATION 1.3 • n=70 Participants
|
2.4 events/week
STANDARD_DEVIATION 1.3 • n=140 Participants
|
|
Sexual Encounter Profile (SEP)
Vaginal penetrations
|
1.5 events/week
STANDARD_DEVIATION 1.3 • n=70 Participants
|
1.4 events/week
STANDARD_DEVIATION 1.1 • n=70 Participants
|
1.4 events/week
STANDARD_DEVIATION 1.2 • n=140 Participants
|
|
Sexual Encounter Profile (SEP)
Ejaculations
|
0.92 events/week
STANDARD_DEVIATION 1.11 • n=70 Participants
|
1.14 events/week
STANDARD_DEVIATION 1.15 • n=70 Participants
|
1.02 events/week
STANDARD_DEVIATION 1.13 • n=140 Participants
|
|
Sexual Encounter Profile (SEP)
Overall satisfied with sexual encounters
|
0.49 events/week
STANDARD_DEVIATION 0.71 • n=70 Participants
|
1.07 events/week
STANDARD_DEVIATION 1.39 • n=70 Participants
|
0.76 events/week
STANDARD_DEVIATION 1.12 • n=140 Participants
|
|
Successful sexual Intercourse in Sexual Encounter Profile (SEP)
Successful sexual Intercourse(Ejaculations)
|
36 percentage of successful intercourse
STANDARD_DEVIATION 40 • n=70 Participants
|
54 percentage of successful intercourse
STANDARD_DEVIATION 45 • n=70 Participants
|
45 percentage of successful intercourse
STANDARD_DEVIATION 43 • n=140 Participants
|
|
Derogatis Affects Balance Scale (DABS)
Anxiety
|
5.4 units on a scale
STANDARD_DEVIATION 3.5 • n=70 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 3.1 • n=70 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 3.4 • n=140 Participants
|
|
Successful sexual Intercourse in Sexual Encounter Profile (SEP)
Successful Sexual Intercourse (Satisfaction)
|
22 percentage of successful intercourse
STANDARD_DEVIATION 34 • n=70 Participants
|
40 percentage of successful intercourse
STANDARD_DEVIATION 45 • n=70 Participants
|
31 percentage of successful intercourse
STANDARD_DEVIATION 40 • n=140 Participants
|
|
Male Sexual Health Questionnaire (MSHQ)
Erection
|
6.7 units on a scale
STANDARD_DEVIATION 1.9 • n=70 Participants
|
6.9 units on a scale
STANDARD_DEVIATION 1.8 • n=70 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 1.9 • n=140 Participants
|
|
Male Sexual Health Questionnaire (MSHQ)
Ejaculation
|
22.2 units on a scale
STANDARD_DEVIATION 6.6 • n=70 Participants
|
22.2 units on a scale
STANDARD_DEVIATION 7.3 • n=70 Participants
|
22.2 units on a scale
STANDARD_DEVIATION 7.0 • n=140 Participants
|
|
Male Sexual Health Questionnaire (MSHQ)
Sexual satisfaction
|
19.5 units on a scale
STANDARD_DEVIATION 5.7 • n=70 Participants
|
18.7 units on a scale
STANDARD_DEVIATION 6.0 • n=70 Participants
|
19.1 units on a scale
STANDARD_DEVIATION 5.8 • n=140 Participants
|
|
Male Sexual Health Questionnaire (MSHQ)
Sexual desire
|
8.6 units on a scale
STANDARD_DEVIATION 2.4 • n=70 Participants
|
8.6 units on a scale
STANDARD_DEVIATION 2.5 • n=70 Participants
|
8.6 units on a scale
STANDARD_DEVIATION 2.4 • n=140 Participants
|
|
Male Sexual Health Questionnaire (MSHQ)
Sexual activity
|
5.5 units on a scale
STANDARD_DEVIATION 1.4 • n=70 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 1.5 • n=70 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 1.4 • n=140 Participants
|
|
Male Sexual Health Questionnaire (MSHQ)
Composite MSHQ
|
41.7 units on a scale
STANDARD_DEVIATION 9.6 • n=70 Participants
|
40.8 units on a scale
STANDARD_DEVIATION 10.6 • n=70 Participants
|
41.2 units on a scale
STANDARD_DEVIATION 10.1 • n=140 Participants
|
|
Quality of Life Specific to Male Erection Difficulties (QOL-MED)
|
47 units on a scale
STANDARD_DEVIATION 25 • n=70 Participants
|
51 units on a scale
STANDARD_DEVIATION 26 • n=70 Participants
|
49 units on a scale
STANDARD_DEVIATION 26 • n=140 Participants
|
|
Marital Interaction scale in CAncer Rehabilitation Evaluation System-Short Form (CARES-SF)
|
0.91 units on a scale
STANDARD_DEVIATION 0.82 • n=70 Participants
|
0.79 units on a scale
STANDARD_DEVIATION 0.78 • n=70 Participants
|
0.85 units on a scale
STANDARD_DEVIATION 0.80 • n=140 Participants
|
|
Psychological Global Well-Being Index (PGWBI)
Anxiety
|
75 units on a scale
STANDARD_DEVIATION 15 • n=70 Participants
|
72 units on a scale
STANDARD_DEVIATION 18 • n=70 Participants
|
74 units on a scale
STANDARD_DEVIATION 17 • n=140 Participants
|
|
Psychological Global Well-Being Index (PGWBI)
Depressed mood
|
86 units on a scale
STANDARD_DEVIATION 14 • n=70 Participants
|
83 units on a scale
STANDARD_DEVIATION 15 • n=70 Participants
|
84 units on a scale
STANDARD_DEVIATION 14 • n=140 Participants
|
|
Psychological Global Well-Being Index (PGWBI)
Positive well-being
|
62 units on a scale
STANDARD_DEVIATION 17 • n=70 Participants
|
61 units on a scale
STANDARD_DEVIATION 19 • n=70 Participants
|
61 units on a scale
STANDARD_DEVIATION 18 • n=140 Participants
|
|
Psychological Global Well-Being Index (PGWBI)
Self-control
|
85 units on a scale
STANDARD_DEVIATION 13 • n=70 Participants
|
84 units on a scale
STANDARD_DEVIATION 14 • n=70 Participants
|
85 units on a scale
STANDARD_DEVIATION 14 • n=140 Participants
|
|
Psychological Global Well-Being Index (PGWBI)
General health
|
73 units on a scale
STANDARD_DEVIATION 16 • n=70 Participants
|
73 units on a scale
STANDARD_DEVIATION 17 • n=70 Participants
|
73 units on a scale
STANDARD_DEVIATION 17 • n=140 Participants
|
|
Psychological Global Well-Being Index (PGWBI)
Vitality
|
65 units on a scale
STANDARD_DEVIATION 15 • n=70 Participants
|
65 units on a scale
STANDARD_DEVIATION 19 • n=70 Participants
|
65 units on a scale
STANDARD_DEVIATION 17 • n=140 Participants
|
|
Psychological Global Well-Being Index (PGWBI)
Global score
|
73 units on a scale
STANDARD_DEVIATION 12 • n=70 Participants
|
72 units on a scale
STANDARD_DEVIATION 14 • n=70 Participants
|
73 units on a scale
STANDARD_DEVIATION 13 • n=140 Participants
|
|
Derogatis Affects Balance Scale (DABS)
Joy
|
13.0 units on a scale
STANDARD_DEVIATION 3.2 • n=70 Participants
|
12.9 units on a scale
STANDARD_DEVIATION 4.3 • n=70 Participants
|
13.0 units on a scale
STANDARD_DEVIATION 3.8 • n=140 Participants
|
|
Derogatis Affects Balance Scale (DABS)
Contentment
|
13.1 units on a scale
STANDARD_DEVIATION 2.9 • n=70 Participants
|
12.8 units on a scale
STANDARD_DEVIATION 3.6 • n=70 Participants
|
12.9 units on a scale
STANDARD_DEVIATION 3.2 • n=140 Participants
|
|
Derogatis Affects Balance Scale (DABS)
Vigor
|
12.2 units on a scale
STANDARD_DEVIATION 3.2 • n=70 Participants
|
12.3 units on a scale
STANDARD_DEVIATION 4.1 • n=70 Participants
|
12.2 units on a scale
STANDARD_DEVIATION 3.7 • n=140 Participants
|
|
Derogatis Affects Balance Scale (DABS)
Affection
|
14.4 units on a scale
STANDARD_DEVIATION 3.6 • n=70 Participants
|
14.2 units on a scale
STANDARD_DEVIATION 3.8 • n=70 Participants
|
14.3 units on a scale
STANDARD_DEVIATION 3.7 • n=140 Participants
|
|
Derogatis Affects Balance Scale (DABS)
Depression
|
3.9 units on a scale
STANDARD_DEVIATION 3.3 • n=70 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 3.7 • n=70 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 3.5 • n=140 Participants
|
|
Derogatis Affects Balance Scale (DABS)
Guilt
|
4.1 units on a scale
STANDARD_DEVIATION 3.7 • n=70 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 3.9 • n=70 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 3.8 • n=140 Participants
|
|
Derogatis Affects Balance Scale (DABS)
Hostiity
|
4.5 units on a scale
STANDARD_DEVIATION 3.5 • n=70 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 3.7 • n=70 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 3.6 • n=140 Participants
|
|
Positive Affect Ratio (PAR) in Derogatis Affects Balance Scale (DABS)
|
0.75 ratios
STANDARD_DEVIATION 0.14 • n=70 Participants
|
0.74 ratios
STANDARD_DEVIATION 0.16 • n=70 Participants
|
0.74 ratios
STANDARD_DEVIATION 0.15 • n=140 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 8, week 11, week 14Population: All available data expressed as absolute value at the given time-point.
IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with Erectile Function domain range of 1 to 30 with higher scores representing better function.
Outcome measures
| Measure |
Testosterone
n=70 Participants
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
n=70 Participants
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF)
Erectile function at week 0
|
19.6 units on a scale
Standard Deviation 7.2
|
20.1 units on a scale
Standard Deviation 7.2
|
|
Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF)
Erectile function at week 8
|
21.3 units on a scale
Standard Deviation 7.4
|
21.3 units on a scale
Standard Deviation 8.0
|
|
Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF)
Erectile function at week 11
|
22.5 units on a scale
Standard Deviation 7.0
|
20.1 units on a scale
Standard Deviation 8.5
|
|
Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF)
Erectile function at week 14
|
21.7 units on a scale
Standard Deviation 7.9
|
19.8 units on a scale
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Week 0, week 8, week 11, week 14Population: All available data expressed as absolute value at the given time-point.
IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.
Outcome measures
| Measure |
Testosterone
n=70 Participants
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
n=70 Participants
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Composite IIEF at week 14
|
53 units on a scale
Standard Deviation 17
|
50 units on a scale
Standard Deviation 18
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Orgasmic function at week 0
|
7.0 units on a scale
Standard Deviation 2.7
|
7.0 units on a scale
Standard Deviation 2.6
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Orgasmic function at week 8
|
7.6 units on a scale
Standard Deviation 2.4
|
7.8 units on a scale
Standard Deviation 2.7
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Orgasmic function at week 11
|
7.9 units on a scale
Standard Deviation 2.5
|
7.4 units on a scale
Standard Deviation 3.0
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Orgasmic function at week 14
|
7.9 units on a scale
Standard Deviation 2.8
|
7.4 units on a scale
Standard Deviation 3.1
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Sexual desire at week 0
|
6.5 units on a scale
Standard Deviation 1.9
|
6.7 units on a scale
Standard Deviation 1.5
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Sexual desire at week 8
|
7.0 units on a scale
Standard Deviation 1.8
|
7.0 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Sexual desire at week 11
|
7.1 units on a scale
Standard Deviation 2.0
|
6.8 units on a scale
Standard Deviation 2.0
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Sexual desire at week 14
|
7.0 units on a scale
Standard Deviation 2.0
|
6.8 units on a scale
Standard Deviation 2.0
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Intercourse satisfaction at week 0
|
9.5 units on a scale
Standard Deviation 3.0
|
9.4 units on a scale
Standard Deviation 3.4
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Intercourse satisfaction at week 8
|
10.1 units on a scale
Standard Deviation 3.3
|
9.8 units on a scale
Standard Deviation 3.9
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Intercourse satisfaction at week 11
|
10.6 units on a scale
Standard Deviation 3.3
|
9.5 units on a scale
Standard Deviation 4.2
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Intercourse satisfaction at week 14
|
10.0 units on a scale
Standard Deviation 4.0
|
8.8 units on a scale
Standard Deviation 4.2
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Overall satisfaction at week 0
|
6.4 units on a scale
Standard Deviation 2.1
|
6.6 units on a scale
Standard Deviation 2.4
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Overall satisfaction at week 8
|
6.8 units on a scale
Standard Deviation 2.2
|
7.3 units on a scale
Standard Deviation 2.2
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Overall satisfaction at week 11
|
7.4 units on a scale
Standard Deviation 2.0
|
7.0 units on a scale
Standard Deviation 2.5
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Overall satisfaction at week 14
|
6.7 units on a scale
Standard Deviation 2.3
|
7.0 units on a scale
Standard Deviation 2.4
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Composite IIEF at week 0
|
47 units on a scale
Standard Deviation 17
|
50 units on a scale
Standard Deviation 18
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Composite IIEF at week 8
|
53 units on a scale
Standard Deviation 15
|
53 units on a scale
Standard Deviation 16
|
|
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
Composite IIEF at week 11
|
56 units on a scale
Standard Deviation 14
|
51 units on a scale
Standard Deviation 18
|
SECONDARY outcome
Timeframe: Week 0, week 8, week 14Population: All available data expressed as absolute value at the given time-point.
Sexual Encounter Profile (SEP) diaries were used to assess frequency of sexual activity, sildenafil use, vaginal penetration, completion of intercourse with ejaculation, and overall satisfaction with sexual encounters. Minimum value is 0 with no maximum limit, wherein higher values representing better sexual encounter.
Outcome measures
| Measure |
Testosterone
n=70 Participants
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
n=70 Participants
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Change From Baseline in Sexual Encounter Profile (SEP)
Sexual Encounter Attempts at week 0
|
2.8 events/week
Standard Deviation 1.5
|
3.0 events/week
Standard Deviation 1.3
|
|
Change From Baseline in Sexual Encounter Profile (SEP)
Sexual Encounter Attempts at week 8
|
2.8 events/week
Standard Deviation 1.2
|
3.0 events/week
Standard Deviation 1.2
|
|
Change From Baseline in Sexual Encounter Profile (SEP)
Sexual Encounter Attempts at week 14
|
3.3 events/week
Standard Deviation 1.6
|
3.0 events/week
Standard Deviation 1.2
|
|
Change From Baseline in Sexual Encounter Profile (SEP)
Vaginal Penetration at week 0
|
2.7 events/week
Standard Deviation 1.4
|
2.6 events/week
Standard Deviation 0.9
|
|
Change From Baseline in Sexual Encounter Profile (SEP)
Vaginal Penetration at week 8
|
2.4 events/week
Standard Deviation 1.1
|
2.7 events/week
Standard Deviation 1.1
|
|
Change From Baseline in Sexual Encounter Profile (SEP)
Vaginal Penetration at week 14
|
2.7 events/week
Standard Deviation 1.4
|
2.6 events/week
Standard Deviation 0.9
|
|
Change From Baseline in Sexual Encounter Profile (SEP)
Ejaculation at week 0
|
2.1 events/week
Standard Deviation 1.6
|
2.2 events/week
Standard Deviation 1.4
|
|
Change From Baseline in Sexual Encounter Profile (SEP)
Ejaculation at week 8
|
2.3 events/week
Standard Deviation 1.5
|
2.5 events/week
Standard Deviation 1.2
|
|
Change From Baseline in Sexual Encounter Profile (SEP)
Ejaculation at week 14
|
2.6 events/week
Standard Deviation 1.7
|
2.3 events/week
Standard Deviation 1.3
|
|
Change From Baseline in Sexual Encounter Profile (SEP)
Overall Satisfied with Sexual Encounters at week0
|
2.0 events/week
Standard Deviation 1.7
|
1.9 events/week
Standard Deviation 1.4
|
|
Change From Baseline in Sexual Encounter Profile (SEP)
Overall Satisfied with Sexual Encounters at week8
|
2.2 events/week
Standard Deviation 1.5
|
2.3 events/week
Standard Deviation 1.4
|
|
Change From Baseline in Sexual Encounter Profile (SEP)
Overall Satisfied with Sexual Encounters at wk 14
|
2.8 events/week
Standard Deviation 1.8
|
2.5 events/week
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Week 0, week 8, week 14Population: All available data expressed as absolute value at the given time-point.
Sexual Encounter Profile (SEP) diaries were used to assess frequency of sexual activity, sildenafil use, vaginal penetration, completion of intercourse with ejaculation, and overall satisfaction with sexual encounters. Higher percentage of Ejaculations or Satisfaction in successful sexual intercourse represents better sexual function.
Outcome measures
| Measure |
Testosterone
n=70 Participants
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
n=70 Participants
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP)
Successful Sexual Intercourse (Ejaculations)wk14
|
80 percentage of sexual intercourses
Standard Deviation 31
|
79 percentage of sexual intercourses
Standard Deviation 37
|
|
Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP)
Successful Sexual Intercourse (Satisfaction) wk0
|
69 percentage of sexual intercourses
Standard Deviation 39
|
67 percentage of sexual intercourses
Standard Deviation 40
|
|
Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP)
Successful Sexual Intercourse (Ejaculations) wk0
|
76 percentage of sexual intercourses
Standard Deviation 37
|
74 percentage of sexual intercourses
Standard Deviation 35
|
|
Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP)
Successful Sexual Intercourse (Ejaculations) wk8
|
78 percentage of sexual intercourses
Standard Deviation 40
|
84 percentage of sexual intercourses
Standard Deviation 29
|
|
Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP)
Successful Sexual Intercourse (Satisfaction) wk8
|
76 percentage of sexual intercourses
Standard Deviation 39
|
75 percentage of sexual intercourses
Standard Deviation 35
|
|
Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP)
Successful Sexual Intercourse (Satisfaction)wk14
|
83 percentage of sexual intercourses
Standard Deviation 34
|
83 percentage of sexual intercourses
Standard Deviation 33
|
SECONDARY outcome
Timeframe: Week 0, Week 8, Week 14Population: All available data expressed as absolute value at the given time-point.
MSHQ, a 25-item questionnaire, assesses sexual function and satisfaction. It consists 5 domains: Erection (3 items, ranging from 0 to 15 (best)), Ejaculation (7 items, ranging from 1 to 35 (best)), Satisfaction (6 items, ranging from 6 to 30 (best)), Sexual desire (4 items, ranging 4-20 (best)), and Sexual activity (3 items, ranging 3-15 (best)). A composite score is the sum of Ejaculation and Satisfaction domains, ranging from 7 to 65 (best), with higher score representing better sexual function and satisfaction.
Outcome measures
| Measure |
Testosterone
n=70 Participants
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
n=70 Participants
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Erectile at week 0
|
5.3 units on a scale
Standard Deviation 3.4
|
5.9 units on a scale
Standard Deviation 2.9
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Erectile at week 8
|
6.3 units on a scale
Standard Deviation 3.8
|
6.9 units on a scale
Standard Deviation 3.7
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Erectile at week 14
|
6.9 units on a scale
Standard Deviation 3.2
|
7.2 units on a scale
Standard Deviation 3.6
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Ejaculation at week 0
|
26.8 units on a scale
Standard Deviation 5.7
|
26.1 units on a scale
Standard Deviation 7.1
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Ejaculation at week 8
|
28.3 units on a scale
Standard Deviation 4.6
|
27.8 units on a scale
Standard Deviation 5.9
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Ejaculation at week 14
|
28.4 units on a scale
Standard Deviation 5.4
|
26.9 units on a scale
Standard Deviation 6.2
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Sexual satisfaction at week 0
|
22.1 units on a scale
Standard Deviation 5.2
|
21.6 units on a scale
Standard Deviation 6.2
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Sexual satisfaction at week 8
|
22.3 units on a scale
Standard Deviation 5.2
|
22.4 units on a scale
Standard Deviation 5.9
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Sexual satisfaction at week 14
|
22.5 units on a scale
Standard Deviation 6.3
|
21.5 units on a scale
Standard Deviation 6.2
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Sexual desire at week 0
|
9.9 units on a scale
Standard Deviation 2.4
|
10.3 units on a scale
Standard Deviation 2.8
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Sexual desire at week 8
|
10.5 units on a scale
Standard Deviation 2.2
|
10.7 units on a scale
Standard Deviation 2.5
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Sexual desire at week 14
|
10.5 units on a scale
Standard Deviation 2.6
|
10.1 units on a scale
Standard Deviation 2.7
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Sexual activity at week 0
|
7.0 units on a scale
Standard Deviation 1.5
|
6.7 units on a scale
Standard Deviation 1.7
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Sexual activity at week 8
|
7.1 units on a scale
Standard Deviation 1.4
|
6.9 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Sexual activity at week 14
|
7.0 units on a scale
Standard Deviation 1.6
|
6.5 units on a scale
Standard Deviation 1.8
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Composite MSHQ at week 0
|
48.8 units on a scale
Standard Deviation 9.1
|
47.7 units on a scale
Standard Deviation 11.4
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Composite MSHQ at week 8
|
50.6 units on a scale
Standard Deviation 7.8
|
50.2 units on a scale
Standard Deviation 9.5
|
|
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
Composite MSHQ at week 14
|
51.1 units on a scale
Standard Deviation 9.4
|
48.5 units on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Week 0, Week 8, Week 14Population: All available data expressed as absolute value at the given time-point.
The Quality of Life for men with Erection Difficulties (QOL-MED) is a cross-cultural instrument to measure quality of life specific to male erection difficulties. The 18 items for this scale were generated from interviews with men with erection difficulties by TH Wagner in 1996. Higher QOL-MED scores reflect better quality of life. Scores were standardized to range of 0 to 100.
Outcome measures
| Measure |
Testosterone
n=70 Participants
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
n=70 Participants
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED)
QOL-MED scale at week 0
|
56 units on a scale
Standard Deviation 26
|
62 units on a scale
Standard Deviation 26
|
|
Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED)
QOL-MED scale at week 8
|
65 units on a scale
Standard Deviation 25
|
70 units on a scale
Standard Deviation 26
|
|
Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED)
QOL-MED scale at week 14
|
66 units on a scale
Standard Deviation 25
|
69 units on a scale
Standard Deviation 25
|
SECONDARY outcome
Timeframe: Week 0, Week 8, Week 14Population: All available data expressed as absolute value at the given time-point.
CAncer Rehabilitation Evaluation System-short form (CARES-SF) marital interaction scale consists of 6 items (range from 0 (best) to 4) and mean of these 6 questions was used to determine intimacy and partner interaction. Lower CARES-SF scores correspond with improved marital interaction.
Outcome measures
| Measure |
Testosterone
n=70 Participants
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
n=70 Participants
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF)
CARES-SF: Marital relationship at week 0
|
0.79 units on a scale
Standard Deviation 0.70
|
0.74 units on a scale
Standard Deviation 0.77
|
|
Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF)
CARES-SF: Marital relationship at week 8
|
0.86 units on a scale
Standard Deviation 0.74
|
0.79 units on a scale
Standard Deviation 0.95
|
|
Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF)
CARES-SF: Marital relationship at week 14
|
0.81 units on a scale
Standard Deviation 0.81
|
0.79 units on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Week 0, Week 8, Week 14Population: All available data expressed as absolute value at the given time-point.
Well-being and mood were assessed using the Psychological General Well-Being Index (PGWBI), a 22-item questionnaire that evaluated six dimensions of self-reported wellness: Anxiety (5 questions), Depressed Mood (3 questions), Positive Well-Being (4 questions), Self Control (3 questions), General Health (3 questions), and Vitality (4 questions). Higher scores in each dimension reflect increasing well-being. A global score (ranging from 0 (poor QoL) to 110 (good QoL)) was calculated as the sum of each domain score. The global score and those of its 6 dimensions were normalized to a 100% scale to facilitate comparison.
Outcome measures
| Measure |
Testosterone
n=70 Participants
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
n=70 Participants
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Global Score at week 8
|
75 units on a scale
Standard Deviation 14
|
75 units on a scale
Standard Deviation 14
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Positive Well-being at week 0
|
60 units on a scale
Standard Deviation 19
|
63 units on a scale
Standard Deviation 18
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Positive Well-being at week 8
|
65 units on a scale
Standard Deviation 18
|
63 units on a scale
Standard Deviation 18
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Positive Well-being at week 14
|
64 units on a scale
Standard Deviation 20
|
60 units on a scale
Standard Deviation 21
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Depressed Mood at week 0
|
86 units on a scale
Standard Deviation 16
|
86 units on a scale
Standard Deviation 15
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Depressed Mood at week 8
|
85 units on a scale
Standard Deviation 15
|
86 units on a scale
Standard Deviation 18
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Depressed Mood at week 14
|
85 units on a scale
Standard Deviation 18
|
83 units on a scale
Standard Deviation 18
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
General Health at week 0
|
72 units on a scale
Standard Deviation 16
|
74 units on a scale
Standard Deviation 17
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
General Health at week 8
|
73 units on a scale
Standard Deviation 19
|
75 units on a scale
Standard Deviation 18
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
General Health at week 14
|
72 units on a scale
Standard Deviation 17
|
70 units on a scale
Standard Deviation 23
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Anxiety at week 0
|
76 units on a scale
Standard Deviation 15
|
76 units on a scale
Standard Deviation 19
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Anxiety at week 8
|
76 units on a scale
Standard Deviation 15
|
76 units on a scale
Standard Deviation 20
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Anxiety at week 14
|
77 units on a scale
Standard Deviation 15
|
72 units on a scale
Standard Deviation 22
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Self Control at week 0
|
86 units on a scale
Standard Deviation 14
|
84 units on a scale
Standard Deviation 15
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Self Control at week 8
|
86 units on a scale
Standard Deviation 17
|
86 units on a scale
Standard Deviation 15
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Self Control at week 14
|
87 units on a scale
Standard Deviation 15
|
84 units on a scale
Standard Deviation 16
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Vitality at week 0
|
66 units on a scale
Standard Deviation 17
|
68 units on a scale
Standard Deviation 18
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Vitality at week 8
|
68 units on a scale
Standard Deviation 17
|
69 units on a scale
Standard Deviation 17
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Vitality at week 14
|
69 units on a scale
Standard Deviation 19
|
67 units on a scale
Standard Deviation 19
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Global Score at week 0
|
73 units on a scale
Standard Deviation 13
|
74 units on a scale
Standard Deviation 15
|
|
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
Global Score at week 14
|
75 units on a scale
Standard Deviation 14
|
72 units on a scale
Standard Deviation 17
|
SECONDARY outcome
Timeframe: Week 0, Week 8, Week 14Population: All available data expressed as absolute value at the given time-point.
The Derogatis Affects Balance Scale (DABS) is a 40-item mood inventory and consists of 4 positive affect dimensions (joy, contentment, vigor, and affection) as well as 4 negative affect dimensions(anxiety, depression, guilt, and hostility). Each domain was calculated as the sum of 5-items and could range from 0 to 20, wherein higher scores indicate greater affectivity.
Outcome measures
| Measure |
Testosterone
n=70 Participants
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
n=70 Participants
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Affection at week 0
|
13.9 units on a scale
Standard Deviation 3.3
|
14.6 units on a scale
Standard Deviation 3.4
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Depression at week 8
|
4.1 units on a scale
Standard Deviation 3.5
|
4.3 units on a scale
Standard Deviation 4.2
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Depression at week 14
|
4.2 units on a scale
Standard Deviation 4.0
|
4.1 units on a scale
Standard Deviation 3.8
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Anxiety at week 0
|
4.9 units on a scale
Standard Deviation 3.3
|
5.5 units on a scale
Standard Deviation 3.8
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Anxiety at week 8
|
5.1 units on a scale
Standard Deviation 3.4
|
5.6 units on a scale
Standard Deviation 3.7
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Anxiety at week 14
|
4.9 units on a scale
Standard Deviation 3.5
|
5.8 units on a scale
Standard Deviation 3.8
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Guilt at week 0
|
3.4 units on a scale
Standard Deviation 3.6
|
4.1 units on a scale
Standard Deviation 3.9
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Guilt at week 8
|
3.7 units on a scale
Standard Deviation 3.6
|
4.5 units on a scale
Standard Deviation 4.4
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Guilt at week 14
|
3.8 units on a scale
Standard Deviation 4.1
|
3.7 units on a scale
Standard Deviation 3.8
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Hostility at week 0
|
4.7 units on a scale
Standard Deviation 3.4
|
4.3 units on a scale
Standard Deviation 3.7
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Hostility at week 8
|
4.6 units on a scale
Standard Deviation 3.3
|
4.6 units on a scale
Standard Deviation 4.3
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Hostility at week 14
|
4.7 units on a scale
Standard Deviation 3.9
|
4.4 units on a scale
Standard Deviation 3.8
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Joy at week 0
|
12.7 units on a scale
Standard Deviation 3.3
|
13.1 units on a scale
Standard Deviation 3.4
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Joy at week 8
|
13.1 units on a scale
Standard Deviation 3.1
|
13.5 units on a scale
Standard Deviation 3.7
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Joy at week 14
|
13.2 units on a scale
Standard Deviation 3.2
|
12.7 units on a scale
Standard Deviation 3.9
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Contentment at week 0
|
12.8 units on a scale
Standard Deviation 3.2
|
13.2 units on a scale
Standard Deviation 3.3
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Contentment at week 8
|
13.4 units on a scale
Standard Deviation 2.8
|
13.7 units on a scale
Standard Deviation 3.5
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Contentment at week 14
|
13.3 units on a scale
Standard Deviation 3.2
|
12.8 units on a scale
Standard Deviation 4.2
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Vigor at week 0
|
11.8 units on a scale
Standard Deviation 3.3
|
12.0 units on a scale
Standard Deviation 3.6
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Vigor at week 8
|
12.5 units on a scale
Standard Deviation 3.1
|
13.0 units on a scale
Standard Deviation 3.8
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Vigor at week 14
|
12.6 units on a scale
Standard Deviation 3.6
|
12.6 units on a scale
Standard Deviation 4.1
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Affection at week 8
|
14.2 units on a scale
Standard Deviation 3.4
|
14.7 units on a scale
Standard Deviation 3.8
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Affection at week 14
|
14.2 units on a scale
Standard Deviation 3.9
|
14.5 units on a scale
Standard Deviation 3.7
|
|
Change From Baseline in Derogatis Affects Balance Scale (DABS)
Depression at week 0
|
4.1 units on a scale
Standard Deviation 3.9
|
3.9 units on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Week 0, Week 8, Week 14Population: All available data expressed as absolute value at the given time-point.
The Derogatis Affects Balance Scale (DABS) is a 40-item mood inventory and consists of 4 positive affect dimensions (joy, contentment, vigor, and affection) as well as 4 negative affect dimensions(anxiety, depression, guilt, and hostility). Positive Affects Ratio (PAR), ranging from 0 to 1, is the proportion of total scores (sum of all 8 domains) that is positive (sum of 4 positive domains). Higher PAR represents better affectivity.
Outcome measures
| Measure |
Testosterone
n=70 Participants
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
n=70 Participants
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS)
Positive Affect Ratio at week 0
|
0.75 ratios
Standard Deviation 0.15
|
0.76 ratios
Standard Deviation 0.16
|
|
Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS)
Positive Affect Ratio at week 8
|
0.76 ratios
Standard Deviation 0.16
|
0.77 ratios
Standard Deviation 0.17
|
|
Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS)
Positive Affect Ratio at week 14
|
0.78 ratios
Standard Deviation 0.17
|
0.76 ratios
Standard Deviation 0.18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0, Week 14Population: All available data expressed as absolute value at the given time-point.
Total testosterone levels were measured between 7:30 and 10:10 a.m. using a liquid chromatography-tandem mass spectrometry assay certified by the Centers for Disease Control and Prevention's Hormone Standardization Program.
Outcome measures
| Measure |
Testosterone
n=70 Participants
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
n=70 Participants
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Change From Baseline in Total Testosterone
Total Testosterone at week 0
|
364 ng/dL
Standard Deviation 192
|
347 ng/dL
Standard Deviation 141
|
|
Change From Baseline in Total Testosterone
Total Testosterone at week 14
|
649 ng/dL
Standard Deviation 411
|
339 ng/dL
Standard Deviation 155
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0, Week 14Population: All available data expressed as absolute value at the given time-point.
Free testosterone levels were calculated from total testosterone at screening and equilibrium dialysis at randomization and at trial end.
Outcome measures
| Measure |
Testosterone
n=70 Participants
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
n=70 Participants
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Change From Baseline in Free Testosterone
Free Testosterone at week 0
|
110 pg/mL
Standard Deviation 79
|
101 pg/mL
Standard Deviation 36
|
|
Change From Baseline in Free Testosterone
Free Testosterone at week 14
|
239 pg/mL
Standard Deviation 197
|
103 pg/mL
Standard Deviation 63
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0, Week 14Population: All available data expressed as absolute value at the given time-point.
Outcome measures
| Measure |
Testosterone
n=70 Participants
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
n=70 Participants
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Change From Baseline in Sex Hormone Binding Globulin (SHBG)
SHBG at week 0
|
32.2 nmol/L
Standard Deviation 14.7
|
27.5 nmol/L
Standard Deviation 14.6
|
|
Change From Baseline in Sex Hormone Binding Globulin (SHBG)
SHBG at week 14
|
32 nmol/L
Standard Deviation 16
|
28 nmol/L
Standard Deviation 15
|
Adverse Events
Testosterone
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Testosterone
n=70 participants at risk
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
n=70 participants at risk
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
1.4%
1/70
|
0.00%
0/70
|
|
Hepatobiliary disorders
Acute cholecystitis
|
1.4%
1/70
|
0.00%
0/70
|
|
Infections and infestations
Cellulitis
|
0.00%
0/70
|
1.4%
1/70
|
|
Surgical and medical procedures
Incisional hernia repair
|
0.00%
0/70
|
1.4%
1/70
|
|
General disorders
Fever
|
0.00%
0/70
|
2.9%
2/70
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/70
|
1.4%
1/70
|
|
Cardiac disorders
Palpitations
|
1.4%
1/70
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Chills
|
0.00%
0/70
|
2.9%
2/70
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/70
|
1.4%
1/70
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/70
|
1.4%
1/70
|
Other adverse events
| Measure |
Testosterone
n=70 participants at risk
Active Testosterone Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.
|
Placebo
n=70 participants at risk
Placebo Gel
Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
10/70
|
10.0%
7/70
|
|
Musculoskeletal and connective tissue disorders
Keen pain
|
5.7%
4/70
|
0.00%
0/70
|
|
Gastrointestinal disorders
Tooth ache
|
7.1%
5/70
|
4.3%
3/70
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
4/70
|
1.4%
1/70
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
4/70
|
2.9%
2/70
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place