Diabetes, Erectile Dysfunction, Testosterone Deficiency
Conditions
Keywords
testosterone, erectile dysfunction, sildenafil
Brief summary
The purpose of this placebo-controlled study is to determine if testosterone replacement therapy, administered by transdermal gel, can improve the response to sildenafil (Viagra R) treatment in men who have erectile dysfunction (ED) and low testosterone levels.
Detailed description
This is a double-blind, placebo-controlled, parallel-group, randomized clinical trial in men, 40-70 years of age, who present with mild to moderate erectile dysfunction and have androgen deficiency defined as serum total testosterone level below 300 ng/dL, measured by liquid chromatography tandem mass spectrometry, LC-MS/MS (15) and/or free testosterone level (measured by equilibrium dialysis) below 50 pg/ml. Sexual function assessments will include validated erectile function questionnaires (IIEF), sexual activity diaries, sexual desire, partner interaction and intimacy, affects balance scale, mood, ED-related quality of life, and penile rigidity in response to a visual erotic stimulus. The initial assessment will be made prior to treatment with sildenafil citrate, i.e., in subjects who are naïve to or withdrawn from PDE5 inhibitors and/or testosterone. Participants will then be allotted three sildenafil citrate tablets per week (12 pills per month), but will not use more than one tablet within any 24-hour period. During the Sildenafil-Dose Optimization period, subjects naïve to sildenafil citrate will start with a 50 mg dose. Those who have used sildenafil citrate in the past will take the same dose that was found to be efficacious for them. After three weeks, the dose of sildenafil citrate will be increased to 100-mg in non-responders. For those who cannot tolerate the 50-mg dose, a dose of 25 mg will be given. After three weeks on the optimized dose of sildenafil citrate, subjects will undergo a second evaluation of sexual function. They will then be randomly assigned to receive this optimized dose of sildenafil citrate with either placebo gel (15 g per day) or active testosterone gel (10 g active gel + 5 g placebo gel per day). The daily dose of active testosterone gel was selected to increase average serum into the upper-half of the normal range for healthy, young men (e.g., 500-1000 ng/dL). In order to assure that serum testosterone levels are in the target range (500-1000 ng/dL), testosterone dose will be adjusted by an unblinded individual two to three weeks after initiation of testosterone/placebo treatment, based on the measurement of serum testosterone levels. If the average testosterone level is less than 500 ng/dL, the daily dose will be increased to 15g of active gel. If the average testosterone is greater than 1,000 ng/dL, the daily dose will be decreased to 5 g of active gel (and 10 g of placebo gel). This dose adjustment will take effect at week 4 (day 28) of treatment. Subjects will be treated for an additional 12-weeks with sildenafil citrate and the optimized dose of testosterone gel or placebo gel. Sexual function will be evaluated at the end of this treatment period.
Interventions
DRUGSildenafil 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.
DRUGTestosterone gel
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.
OTHERPlacebo gel
3 tubes of placebo gel equivalent to the amount of the testosterone gel will be applied during the placebo-controlled testosterone gel intervention for 16 weeks..
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Men, 40-70 years of age, in a stable relationship, with mild to moderate erectile dysfunction for at least 6 months; defined as an IIEF-EF domain score between 11 and 25 (mild to moderate ED) * Neutral or extremely dissatisfied with one's sex life * Presence of androgen deficiency defined as serum total testosterone level less than 300 ng/dL (measured by LC-MS/MS) and/or free testosterone level (measured by equilibrium dialysis) less than 50 pg/ml. * Able to understand the nature of the study and provide written, informed consent
Exclusion criteria
* Contraindication for use of testosterone, e.g., history of prostate or breast cancer * benign prostatic hyperplasia with AUA/IPSS symptom scores of 21 or greater * erythrocytosis (hematocrit \>50% at baseline) * untreated, severe sleep apnea * serum PSA levels \>4 ug/L will be excluded unless they have had a urologic evaluation in the past three months to exclude prostate cancer. * Contraindication for use of sildenafil, e.g., symptomatic coronary artery disease taking long-acting or short-acting nitrate drugs on a regular basis. * Symptomatic postural hypotension * Congestive heart failure with class III or IV symptoms * History of myocardial infarction or stroke within the past six months * Primary diagnosis of another sexual disorder such as premature ejaculation * AST, ALT, alkaline phosphatase elevation greater than three times the upper limit of normal, creatinine greater than 2 mg/dL. * Currently taking testosterone or oral androgen precursors; unless willing to discontinue their use for 4 weeks (oral precursors or transdermal testosterone patch or gel) or 6 weeks (if injectable testosterone) before the initial screen visit. * Currently taking medications that affect androgen metabolism, action, or clearance (dilantin, phenobarbital, aldactone, flutamide, finasteride). * Uncontrolled diabetes mellitus or diabetes mellitus, e.g., if their baseline hemoglobin A1C is less than 8.5%. * Structural abnormalities of the penis, including Peyronie's disease, will be excluded. * Men who are taking medications for erectile dysfunction, including sildenafil, must stop using these medications for at least 4 weeks before starting Visit 2. * DSM-IV criteria for an Axis I psychiatric disorder within the past year, including depression; use of psychotropic medication for at least six months, or dementia is also an exclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF) | Week 0, week 8, week 11, week 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Week 0, Week 8, Week 14 | 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. |
| Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Week 0, Week 8, Week 14 | 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. |
| Change From Baseline in Derogatis Affects Balance Scale (DABS) | Week 0, Week 8, Week 14 | 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. |
| Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS) | Week 0, Week 8, Week 14 | 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. |
| Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Week 0, week 8, week 11, week 14 | 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. |
| Change From Baseline in Sexual Encounter Profile (SEP) | Week 0, week 8, week 14 | 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. |
| Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP) | Week 0, week 8, week 14 | 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. |
| Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED) | Week 0, Week 8, Week 14 | 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. |
| Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF) | Week 0, Week 8, Week 14 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Sex Hormone Binding Globulin (SHBG) | Week 0, Week 14 | — |
| Change From Baseline in Free Testosterone | Week 0, Week 14 | Free testosterone levels were calculated from total testosterone at screening and equilibrium dialysis at randomization and at trial end. |
| Change From Baseline in Total Testosterone | Week 0, Week 14 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 70 |
| 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. | 70 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Developed a hematocrit exceeding 0.54 | 2 | 0 |
| Overall Study | Developed skin irritation | 2 | 1 |
| Overall Study | Lost to Follow-up | 5 | 11 |
| Overall Study | Unable to tolerate the smell of the gel | 1 | 0 |
Baseline characteristics
| Characteristic | Testosterone | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 55.1 years STANDARD_DEVIATION 8.3 | 54.9 years STANDARD_DEVIATION 8.4 | 54.6 years STANDARD_DEVIATION 8.5 |
| BMI | 31.5 kg/m^2 STANDARD_DEVIATION 6.4 | 32.1 kg/m^2 STANDARD_DEVIATION 6.2 | 32.7 kg/m^2 STANDARD_DEVIATION 6 |
| Cardiovascular disease | 35 Participants | 67 Participants | 32 Participants |
| Derogatis Affects Balance Scale (DABS) Affection | 14.4 units on a scale STANDARD_DEVIATION 3.6 | 14.3 units on a scale STANDARD_DEVIATION 3.7 | 14.2 units on a scale STANDARD_DEVIATION 3.8 |
| Derogatis Affects Balance Scale (DABS) Anxiety | 5.4 units on a scale STANDARD_DEVIATION 3.5 | 5.8 units on a scale STANDARD_DEVIATION 3.4 | 6.2 units on a scale STANDARD_DEVIATION 3.1 |
| Derogatis Affects Balance Scale (DABS) Contentment | 13.1 units on a scale STANDARD_DEVIATION 2.9 | 12.9 units on a scale STANDARD_DEVIATION 3.2 | 12.8 units on a scale STANDARD_DEVIATION 3.6 |
| Derogatis Affects Balance Scale (DABS) Depression | 3.9 units on a scale STANDARD_DEVIATION 3.3 | 4.3 units on a scale STANDARD_DEVIATION 3.5 | 4.7 units on a scale STANDARD_DEVIATION 3.7 |
| Derogatis Affects Balance Scale (DABS) Guilt | 4.1 units on a scale STANDARD_DEVIATION 3.7 | 4.3 units on a scale STANDARD_DEVIATION 3.8 | 4.4 units on a scale STANDARD_DEVIATION 3.9 |
| Derogatis Affects Balance Scale (DABS) Hostiity | 4.5 units on a scale STANDARD_DEVIATION 3.5 | 4.7 units on a scale STANDARD_DEVIATION 3.6 | 4.8 units on a scale STANDARD_DEVIATION 3.7 |
| Derogatis Affects Balance Scale (DABS) Joy | 13.0 units on a scale STANDARD_DEVIATION 3.2 | 13.0 units on a scale STANDARD_DEVIATION 3.8 | 12.9 units on a scale STANDARD_DEVIATION 4.3 |
| Derogatis Affects Balance Scale (DABS) Vigor | 12.2 units on a scale STANDARD_DEVIATION 3.2 | 12.2 units on a scale STANDARD_DEVIATION 3.7 | 12.3 units on a scale STANDARD_DEVIATION 4.1 |
| Diabetes mellitus | 13 Participants | 27 Participants | 14 Participants |
| Free testosterone level | 45 pg/mL STANDARD_DEVIATION 15 | 46 pg/mL STANDARD_DEVIATION 15 | 47 pg/mL STANDARD_DEVIATION 16 |
| Hypertension | 29 Participants | 56 Participants | 27 Participants |
| International Index of Erectile Function (IIEF) Composite IIEF | 33 units on a scale STANDARD_DEVIATION 13 | 33 units on a scale STANDARD_DEVIATION 13 | 33 units on a scale STANDARD_DEVIATION 14 |
| International Index of Erectile Function (IIEF) Erectile function | 12.2 units on a scale STANDARD_DEVIATION 5.9 | 12.1 units on a scale STANDARD_DEVIATION 6.2 | 12.0 units on a scale STANDARD_DEVIATION 6.5 |
| International Index of Erectile Function (IIEF) Intercourse satisfaction | 6.1 units on a scale STANDARD_DEVIATION 3.4 | 6.0 units on a scale STANDARD_DEVIATION 3.5 | 6.0 units on a scale STANDARD_DEVIATION 3.6 |
| International Index of Erectile Function (IIEF) Orgasmic function | 5.1 units on a scale STANDARD_DEVIATION 3 | 5.3 units on a scale STANDARD_DEVIATION 3.1 | 5.4 units on a scale STANDARD_DEVIATION 3.1 |
| International Index of Erectile Function (IIEF) Overall satisfaction | 4.3 units on a scale STANDARD_DEVIATION 1.9 | 4.4 units on a scale STANDARD_DEVIATION 2 | 4.5 units on a scale STANDARD_DEVIATION 2.1 |
| International Index of Erectile Function (IIEF) Sexual desire | 5.6 units on a scale STANDARD_DEVIATION 1.9 | 5.6 units on a scale STANDARD_DEVIATION 1.9 | 5.6 units on a scale STANDARD_DEVIATION 1.9 |
| Male Sexual Health Questionnaire (MSHQ) Composite MSHQ | 41.7 units on a scale STANDARD_DEVIATION 9.6 | 41.2 units on a scale STANDARD_DEVIATION 10.1 | 40.8 units on a scale STANDARD_DEVIATION 10.6 |
| Male Sexual Health Questionnaire (MSHQ) Ejaculation | 22.2 units on a scale STANDARD_DEVIATION 6.6 | 22.2 units on a scale STANDARD_DEVIATION 7 | 22.2 units on a scale STANDARD_DEVIATION 7.3 |
| Male Sexual Health Questionnaire (MSHQ) Erection | 6.7 units on a scale STANDARD_DEVIATION 1.9 | 6.8 units on a scale STANDARD_DEVIATION 1.9 | 6.9 units on a scale STANDARD_DEVIATION 1.8 |
| Male Sexual Health Questionnaire (MSHQ) Sexual activity | 5.5 units on a scale STANDARD_DEVIATION 1.4 | 5.5 units on a scale STANDARD_DEVIATION 1.4 | 5.6 units on a scale STANDARD_DEVIATION 1.5 |
| Male Sexual Health Questionnaire (MSHQ) Sexual desire | 8.6 units on a scale STANDARD_DEVIATION 2.4 | 8.6 units on a scale STANDARD_DEVIATION 2.4 | 8.6 units on a scale STANDARD_DEVIATION 2.5 |
| Male Sexual Health Questionnaire (MSHQ) Sexual satisfaction | 19.5 units on a scale STANDARD_DEVIATION 5.7 | 19.1 units on a scale STANDARD_DEVIATION 5.8 | 18.7 units on a scale STANDARD_DEVIATION 6 |
| Marital Interaction scale in CAncer Rehabilitation Evaluation System-Short Form (CARES-SF) | 0.91 units on a scale STANDARD_DEVIATION 0.82 | 0.85 units on a scale STANDARD_DEVIATION 0.8 | 0.79 units on a scale STANDARD_DEVIATION 0.78 |
| Positive Affect Ratio (PAR) in Derogatis Affects Balance Scale (DABS) | 0.75 ratios STANDARD_DEVIATION 0.14 | 0.74 ratios STANDARD_DEVIATION 0.15 | 0.74 ratios STANDARD_DEVIATION 0.16 |
| Psychological Global Well-Being Index (PGWBI) Anxiety | 75 units on a scale STANDARD_DEVIATION 15 | 74 units on a scale STANDARD_DEVIATION 17 | 72 units on a scale STANDARD_DEVIATION 18 |
| Psychological Global Well-Being Index (PGWBI) Depressed mood | 86 units on a scale STANDARD_DEVIATION 14 | 84 units on a scale STANDARD_DEVIATION 14 | 83 units on a scale STANDARD_DEVIATION 15 |
| Psychological Global Well-Being Index (PGWBI) General health | 73 units on a scale STANDARD_DEVIATION 16 | 73 units on a scale STANDARD_DEVIATION 17 | 73 units on a scale STANDARD_DEVIATION 17 |
| Psychological Global Well-Being Index (PGWBI) Global score | 73 units on a scale STANDARD_DEVIATION 12 | 73 units on a scale STANDARD_DEVIATION 13 | 72 units on a scale STANDARD_DEVIATION 14 |
| Psychological Global Well-Being Index (PGWBI) Positive well-being | 62 units on a scale STANDARD_DEVIATION 17 | 61 units on a scale STANDARD_DEVIATION 18 | 61 units on a scale STANDARD_DEVIATION 19 |
| Psychological Global Well-Being Index (PGWBI) Self-control | 85 units on a scale STANDARD_DEVIATION 13 | 85 units on a scale STANDARD_DEVIATION 14 | 84 units on a scale STANDARD_DEVIATION 14 |
| Psychological Global Well-Being Index (PGWBI) Vitality | 65 units on a scale STANDARD_DEVIATION 15 | 65 units on a scale STANDARD_DEVIATION 17 | 65 units on a scale STANDARD_DEVIATION 19 |
| Quality of Life Specific to Male Erection Difficulties (QOL-MED) | 47 units on a scale STANDARD_DEVIATION 25 | 49 units on a scale STANDARD_DEVIATION 26 | 51 units on a scale STANDARD_DEVIATION 26 |
| Race/Ethnicity, Customized Race Black | 28 Participants | 61 Participants | 33 Participants |
| Race/Ethnicity, Customized Race Other | 4 Participants | 9 Participants | 5 Participants |
| Race/Ethnicity, Customized Race White | 36 Participants | 68 Participants | 32 Participants |
| Sex/Gender, Customized Male | 70 Participants | 140 Participants | 70 Participants |
| Sexual Encounter Profile (SEP) Ejaculations | 0.92 events/week STANDARD_DEVIATION 1.11 | 1.02 events/week STANDARD_DEVIATION 1.13 | 1.14 events/week STANDARD_DEVIATION 1.15 |
| Sexual Encounter Profile (SEP) Overall satisfied with sexual encounters | 0.49 events/week STANDARD_DEVIATION 0.71 | 0.76 events/week STANDARD_DEVIATION 1.12 | 1.07 events/week STANDARD_DEVIATION 1.39 |
| Sexual Encounter Profile (SEP) Sexual encounter attempts | 2.5 events/week STANDARD_DEVIATION 1.4 | 2.4 events/week STANDARD_DEVIATION 1.3 | 2.3 events/week STANDARD_DEVIATION 1.3 |
| Sexual Encounter Profile (SEP) Vaginal penetrations | 1.5 events/week STANDARD_DEVIATION 1.3 | 1.4 events/week STANDARD_DEVIATION 1.2 | 1.4 events/week STANDARD_DEVIATION 1.1 |
| Successful sexual Intercourse in Sexual Encounter Profile (SEP) Successful sexual Intercourse(Ejaculations) | 36 percentage of successful intercourse STANDARD_DEVIATION 40 | 45 percentage of successful intercourse STANDARD_DEVIATION 43 | 54 percentage of successful intercourse STANDARD_DEVIATION 45 |
| Successful sexual Intercourse in Sexual Encounter Profile (SEP) Successful Sexual Intercourse (Satisfaction) | 22 percentage of successful intercourse STANDARD_DEVIATION 34 | 31 percentage of successful intercourse STANDARD_DEVIATION 40 | 40 percentage of successful intercourse STANDARD_DEVIATION 45 |
| Total testosterone level | 248 ng/dL STANDARD_DEVIATION 62 | 251 ng/dL STANDARD_DEVIATION 65 | 254 ng/dL STANDARD_DEVIATION 68 |
| Total testosterone level <250 ng/dL | 31 Participants | 59 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 70 |
| other Total, other adverse events | 27 / 70 | 13 / 70 |
| serious Total, serious adverse events | 2 / 70 | 4 / 70 |
Outcome results
Primary
Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF)
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.
Time frame: Week 0, week 8, week 11, week 14
Population: All available data expressed as absolute value at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Placebo | Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF) | Erectile function at week 14 | 19.8 units on a scale | Standard Deviation 8.6 |
| Placebo | Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF) | Erectile function at week 0 | 20.1 units on a scale | Standard Deviation 7.2 |
| Placebo | Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF) | Erectile function at week 11 | 20.1 units on a scale | Standard Deviation 8.5 |
| Placebo | 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 8 |
Secondary
Change From Baseline in Derogatis Affects Balance Scale (DABS)
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.
Time frame: Week 0, Week 8, Week 14
Population: All available data expressed as absolute value at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Contentment at week 14 | 13.3 units on a scale | Standard Deviation 3.2 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Hostility at week 8 | 4.6 units on a scale | Standard Deviation 3.3 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Joy at week 0 | 12.7 units on a scale | Standard Deviation 3.3 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Joy at week 8 | 13.1 units on a scale | Standard Deviation 3.1 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Joy at week 14 | 13.2 units on a scale | Standard Deviation 3.2 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Contentment at week 0 | 12.8 units on a scale | Standard Deviation 3.2 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Contentment at week 8 | 13.4 units on a scale | Standard Deviation 2.8 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Guilt at week 8 | 3.7 units on a scale | Standard Deviation 3.6 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Vigor at week 0 | 11.8 units on a scale | Standard Deviation 3.3 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Vigor at week 8 | 12.5 units on a scale | Standard Deviation 3.1 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Vigor at week 14 | 12.6 units on a scale | Standard Deviation 3.6 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Affection at week 0 | 13.9 units on a scale | Standard Deviation 3.3 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Affection at week 8 | 14.2 units on a scale | Standard Deviation 3.4 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Affection at week 14 | 14.2 units on a scale | Standard Deviation 3.9 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Depression at week 0 | 4.1 units on a scale | Standard Deviation 3.9 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Depression at week 8 | 4.1 units on a scale | Standard Deviation 3.5 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Depression at week 14 | 4.2 units on a scale | Standard Deviation 4 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Anxiety at week 0 | 4.9 units on a scale | Standard Deviation 3.3 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Anxiety at week 8 | 5.1 units on a scale | Standard Deviation 3.4 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Anxiety at week 14 | 4.9 units on a scale | Standard Deviation 3.5 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Guilt at week 0 | 3.4 units on a scale | Standard Deviation 3.6 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Guilt at week 14 | 3.8 units on a scale | Standard Deviation 4.1 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Hostility at week 0 | 4.7 units on a scale | Standard Deviation 3.4 |
| Testosterone | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Hostility at week 14 | 4.7 units on a scale | Standard Deviation 3.9 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Anxiety at week 14 | 5.8 units on a scale | Standard Deviation 3.8 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Affection at week 14 | 14.5 units on a scale | Standard Deviation 3.7 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Hostility at week 0 | 4.3 units on a scale | Standard Deviation 3.7 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Joy at week 0 | 13.1 units on a scale | Standard Deviation 3.4 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Depression at week 0 | 3.9 units on a scale | Standard Deviation 3.7 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Joy at week 8 | 13.5 units on a scale | Standard Deviation 3.7 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Guilt at week 0 | 4.1 units on a scale | Standard Deviation 3.9 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Joy at week 14 | 12.7 units on a scale | Standard Deviation 3.9 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Depression at week 8 | 4.3 units on a scale | Standard Deviation 4.2 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Contentment at week 0 | 13.2 units on a scale | Standard Deviation 3.3 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Guilt at week 8 | 4.5 units on a scale | Standard Deviation 4.4 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Contentment at week 8 | 13.7 units on a scale | Standard Deviation 3.5 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Depression at week 14 | 4.1 units on a scale | Standard Deviation 3.8 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Contentment at week 14 | 12.8 units on a scale | Standard Deviation 4.2 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Hostility at week 8 | 4.6 units on a scale | Standard Deviation 4.3 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Vigor at week 0 | 12.0 units on a scale | Standard Deviation 3.6 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Anxiety at week 0 | 5.5 units on a scale | Standard Deviation 3.8 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Vigor at week 8 | 13.0 units on a scale | Standard Deviation 3.8 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Guilt at week 14 | 3.7 units on a scale | Standard Deviation 3.8 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Vigor at week 14 | 12.6 units on a scale | Standard Deviation 4.1 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Anxiety at week 8 | 5.6 units on a scale | Standard Deviation 3.7 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Affection at week 0 | 14.6 units on a scale | Standard Deviation 3.4 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Hostility at week 14 | 4.4 units on a scale | Standard Deviation 3.8 |
| Placebo | Change From Baseline in Derogatis Affects Balance Scale (DABS) | Affection at week 8 | 14.7 units on a scale | Standard Deviation 3.8 |
Secondary
Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF)
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.
Time frame: Week 0, Week 8, Week 14
Population: All available data expressed as absolute value at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone | 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 0.7 |
| Testosterone | 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 |
| Testosterone | 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 |
| Placebo | Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF) | CARES-SF: Marital relationship at week 0 | 0.74 units on a scale | Standard Deviation 0.77 |
| Placebo | Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF) | CARES-SF: Marital relationship at week 8 | 0.79 units on a scale | Standard Deviation 0.95 |
| Placebo | Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF) | CARES-SF: Marital relationship at week 14 | 0.79 units on a scale | Standard Deviation 0.79 |
Secondary
Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
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.
Time frame: Week 0, Week 8, Week 14
Population: All available data expressed as absolute value at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone | 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 |
| Testosterone | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Ejaculation at week 8 | 28.3 units on a scale | Standard Deviation 4.6 |
| Testosterone | 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 |
| Testosterone | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Erectile at week 14 | 6.9 units on a scale | Standard Deviation 3.2 |
| Testosterone | 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 |
| Testosterone | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Ejaculation at week 14 | 28.4 units on a scale | Standard Deviation 5.4 |
| Testosterone | 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 |
| Testosterone | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Erectile at week 8 | 6.3 units on a scale | Standard Deviation 3.8 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Ejaculation at week 0 | 26.8 units on a scale | Standard Deviation 5.7 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Erectile at week 0 | 5.3 units on a scale | Standard Deviation 3.4 |
| Testosterone | 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 |
| Testosterone | 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 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Composite MSHQ at week 14 | 48.5 units on a scale | Standard Deviation 10.5 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Erectile at week 0 | 5.9 units on a scale | Standard Deviation 2.9 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Erectile at week 8 | 6.9 units on a scale | Standard Deviation 3.7 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Erectile at week 14 | 7.2 units on a scale | Standard Deviation 3.6 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Ejaculation at week 0 | 26.1 units on a scale | Standard Deviation 7.1 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Ejaculation at week 8 | 27.8 units on a scale | Standard Deviation 5.9 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Ejaculation at week 14 | 26.9 units on a scale | Standard Deviation 6.2 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Sexual satisfaction at week 0 | 21.6 units on a scale | Standard Deviation 6.2 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Sexual satisfaction at week 8 | 22.4 units on a scale | Standard Deviation 5.9 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Sexual desire at week 0 | 10.3 units on a scale | Standard Deviation 2.8 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Sexual desire at week 8 | 10.7 units on a scale | Standard Deviation 2.5 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Sexual desire at week 14 | 10.1 units on a scale | Standard Deviation 2.7 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Sexual activity at week 0 | 6.7 units on a scale | Standard Deviation 1.7 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Sexual activity at week 8 | 6.9 units on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Sexual activity at week 14 | 6.5 units on a scale | Standard Deviation 1.8 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Composite MSHQ at week 0 | 47.7 units on a scale | Standard Deviation 11.4 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Composite MSHQ at week 8 | 50.2 units on a scale | Standard Deviation 9.5 |
| Placebo | Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) | Sexual satisfaction at week 14 | 21.5 units on a scale | Standard Deviation 6.2 |
Secondary
Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
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.
Time frame: Week 0, week 8, week 11, week 14
Population: All available data expressed as absolute value at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Composite IIEF at week 14 | 50 units on a scale | Standard Deviation 18 |
| Placebo | 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 1.6 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Intercourse satisfaction at week 11 | 9.5 units on a scale | Standard Deviation 4.2 |
| Placebo | 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 16 |
| Placebo | 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 2.6 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Orgasmic function at week 8 | 7.8 units on a scale | Standard Deviation 2.7 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Orgasmic function at week 14 | 7.4 units on a scale | Standard Deviation 3.1 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Sexual desire at week 0 | 6.7 units on a scale | Standard Deviation 1.5 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Sexual desire at week 11 | 6.8 units on a scale | Standard Deviation 2 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Sexual desire at week 14 | 6.8 units on a scale | Standard Deviation 2 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Intercourse satisfaction at week 0 | 9.4 units on a scale | Standard Deviation 3.4 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Intercourse satisfaction at week 8 | 9.8 units on a scale | Standard Deviation 3.9 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Intercourse satisfaction at week 14 | 8.8 units on a scale | Standard Deviation 4.2 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Overall satisfaction at week 0 | 6.6 units on a scale | Standard Deviation 2.4 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Overall satisfaction at week 8 | 7.3 units on a scale | Standard Deviation 2.2 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Overall satisfaction at week 11 | 7.0 units on a scale | Standard Deviation 2.5 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Overall satisfaction at week 14 | 7.0 units on a scale | Standard Deviation 2.4 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Composite IIEF at week 0 | 50 units on a scale | Standard Deviation 18 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Composite IIEF at week 11 | 51 units on a scale | Standard Deviation 18 |
| Placebo | Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) | Orgasmic function at week 11 | 7.4 units on a scale | Standard Deviation 3 |
Secondary
Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS)
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.
Time frame: Week 0, Week 8, Week 14
Population: All available data expressed as absolute value at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Placebo | Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS) | Positive Affect Ratio at week 0 | 0.76 ratios | Standard Deviation 0.16 |
| Placebo | Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS) | Positive Affect Ratio at week 8 | 0.77 ratios | Standard Deviation 0.17 |
| Placebo | Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS) | Positive Affect Ratio at week 14 | 0.76 ratios | Standard Deviation 0.18 |
Secondary
Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
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.
Time frame: Week 0, Week 8, Week 14
Population: All available data expressed as absolute value at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | General Health at week 8 | 73 units on a scale | Standard Deviation 19 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Depressed Mood at week 0 | 86 units on a scale | Standard Deviation 16 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Depressed Mood at week 8 | 85 units on a scale | Standard Deviation 15 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Depressed Mood at week 14 | 85 units on a scale | Standard Deviation 18 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | General Health at week 0 | 72 units on a scale | Standard Deviation 16 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | General Health at week 14 | 72 units on a scale | Standard Deviation 17 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Anxiety at week 0 | 76 units on a scale | Standard Deviation 15 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Anxiety at week 8 | 76 units on a scale | Standard Deviation 15 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Anxiety at week 14 | 77 units on a scale | Standard Deviation 15 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Self Control at week 0 | 86 units on a scale | Standard Deviation 14 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Self Control at week 8 | 86 units on a scale | Standard Deviation 17 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Self Control at week 14 | 87 units on a scale | Standard Deviation 15 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Vitality at week 0 | 66 units on a scale | Standard Deviation 17 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Vitality at week 8 | 68 units on a scale | Standard Deviation 17 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Vitality at week 14 | 69 units on a scale | Standard Deviation 19 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Global Score at week 0 | 73 units on a scale | Standard Deviation 13 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Global Score at week 8 | 75 units on a scale | Standard Deviation 14 |
| Testosterone | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Global Score at week 14 | 75 units on a scale | Standard Deviation 14 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Vitality at week 0 | 68 units on a scale | Standard Deviation 18 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | General Health at week 14 | 70 units on a scale | Standard Deviation 23 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Anxiety at week 8 | 76 units on a scale | Standard Deviation 20 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Global Score at week 0 | 74 units on a scale | Standard Deviation 15 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Positive Well-being at week 0 | 63 units on a scale | Standard Deviation 18 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Anxiety at week 14 | 72 units on a scale | Standard Deviation 22 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Positive Well-being at week 8 | 63 units on a scale | Standard Deviation 18 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Vitality at week 8 | 69 units on a scale | Standard Deviation 17 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Positive Well-being at week 14 | 60 units on a scale | Standard Deviation 21 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Self Control at week 0 | 84 units on a scale | Standard Deviation 15 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Depressed Mood at week 0 | 86 units on a scale | Standard Deviation 15 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Global Score at week 14 | 72 units on a scale | Standard Deviation 17 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Depressed Mood at week 8 | 86 units on a scale | Standard Deviation 18 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Self Control at week 8 | 86 units on a scale | Standard Deviation 15 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Depressed Mood at week 14 | 83 units on a scale | Standard Deviation 18 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Vitality at week 14 | 67 units on a scale | Standard Deviation 19 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | General Health at week 0 | 74 units on a scale | Standard Deviation 17 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | General Health at week 8 | 75 units on a scale | Standard Deviation 18 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Self Control at week 14 | 84 units on a scale | Standard Deviation 16 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Global Score at week 8 | 75 units on a scale | Standard Deviation 14 |
| Placebo | Change From Baseline in Psychological General Well-Being Index Score (PGWBI) | Anxiety at week 0 | 76 units on a scale | Standard Deviation 19 |
Secondary
Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED)
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.
Time frame: Week 0, Week 8, Week 14
Population: All available data expressed as absolute value at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Placebo | Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED) | QOL-MED scale at week 0 | 62 units on a scale | Standard Deviation 26 |
| Placebo | Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED) | QOL-MED scale at week 8 | 70 units on a scale | Standard Deviation 26 |
| Placebo | Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED) | QOL-MED scale at week 14 | 69 units on a scale | Standard Deviation 25 |
Secondary
Change From Baseline in Sexual Encounter Profile (SEP)
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.
Time frame: Week 0, week 8, week 14
Population: All available data expressed as absolute value at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone | Change From Baseline in Sexual Encounter Profile (SEP) | Sexual Encounter Attempts at week 0 | 2.8 events/week | Standard Deviation 1.5 |
| Testosterone | Change From Baseline in Sexual Encounter Profile (SEP) | Vaginal Penetration at week 14 | 2.7 events/week | Standard Deviation 1.4 |
| Testosterone | Change From Baseline in Sexual Encounter Profile (SEP) | Sexual Encounter Attempts at week 8 | 2.8 events/week | Standard Deviation 1.2 |
| Testosterone | Change From Baseline in Sexual Encounter Profile (SEP) | Sexual Encounter Attempts at week 14 | 3.3 events/week | Standard Deviation 1.6 |
| Testosterone | Change From Baseline in Sexual Encounter Profile (SEP) | Vaginal Penetration at week 0 | 2.7 events/week | Standard Deviation 1.4 |
| Testosterone | Change From Baseline in Sexual Encounter Profile (SEP) | Vaginal Penetration at week 8 | 2.4 events/week | Standard Deviation 1.1 |
| Testosterone | Change From Baseline in Sexual Encounter Profile (SEP) | Ejaculation at week 0 | 2.1 events/week | Standard Deviation 1.6 |
| Testosterone | Change From Baseline in Sexual Encounter Profile (SEP) | Ejaculation at week 8 | 2.3 events/week | Standard Deviation 1.5 |
| Testosterone | Change From Baseline in Sexual Encounter Profile (SEP) | Ejaculation at week 14 | 2.6 events/week | Standard Deviation 1.7 |
| Testosterone | Change From Baseline in Sexual Encounter Profile (SEP) | Overall Satisfied with Sexual Encounters at week0 | 2.0 events/week | Standard Deviation 1.7 |
| Testosterone | Change From Baseline in Sexual Encounter Profile (SEP) | Overall Satisfied with Sexual Encounters at week8 | 2.2 events/week | Standard Deviation 1.5 |
| Testosterone | Change From Baseline in Sexual Encounter Profile (SEP) | Overall Satisfied with Sexual Encounters at wk 14 | 2.8 events/week | Standard Deviation 1.8 |
| Placebo | Change From Baseline in Sexual Encounter Profile (SEP) | Overall Satisfied with Sexual Encounters at week8 | 2.3 events/week | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Sexual Encounter Profile (SEP) | Ejaculation at week 0 | 2.2 events/week | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Sexual Encounter Profile (SEP) | Vaginal Penetration at week 14 | 2.6 events/week | Standard Deviation 0.9 |
| Placebo | Change From Baseline in Sexual Encounter Profile (SEP) | Sexual Encounter Attempts at week 0 | 3.0 events/week | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Sexual Encounter Profile (SEP) | Overall Satisfied with Sexual Encounters at week0 | 1.9 events/week | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Sexual Encounter Profile (SEP) | Sexual Encounter Attempts at week 8 | 3.0 events/week | Standard Deviation 1.2 |
| Placebo | Change From Baseline in Sexual Encounter Profile (SEP) | Ejaculation at week 8 | 2.5 events/week | Standard Deviation 1.2 |
| Placebo | Change From Baseline in Sexual Encounter Profile (SEP) | Sexual Encounter Attempts at week 14 | 3.0 events/week | Standard Deviation 1.2 |
| Placebo | Change From Baseline in Sexual Encounter Profile (SEP) | Overall Satisfied with Sexual Encounters at wk 14 | 2.5 events/week | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Sexual Encounter Profile (SEP) | Vaginal Penetration at week 0 | 2.6 events/week | Standard Deviation 0.9 |
| Placebo | Change From Baseline in Sexual Encounter Profile (SEP) | Ejaculation at week 14 | 2.3 events/week | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Sexual Encounter Profile (SEP) | Vaginal Penetration at week 8 | 2.7 events/week | Standard Deviation 1.1 |
Secondary
Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP)
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.
Time frame: Week 0, week 8, week 14
Population: All available data expressed as absolute value at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Testosterone | 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 |
| Placebo | Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP) | Successful Sexual Intercourse (Satisfaction) wk8 | 75 percentage of sexual intercourses | Standard Deviation 35 |
| Placebo | Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP) | Successful Sexual Intercourse (Ejaculations) wk0 | 74 percentage of sexual intercourses | Standard Deviation 35 |
| Placebo | Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP) | Successful Sexual Intercourse (Satisfaction) wk0 | 67 percentage of sexual intercourses | Standard Deviation 40 |
| Placebo | Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP) | Successful Sexual Intercourse (Ejaculations) wk8 | 84 percentage of sexual intercourses | Standard Deviation 29 |
| Placebo | Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP) | Successful Sexual Intercourse (Satisfaction)wk14 | 83 percentage of sexual intercourses | Standard Deviation 33 |
| Placebo | Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP) | Successful Sexual Intercourse (Ejaculations)wk14 | 79 percentage of sexual intercourses | Standard Deviation 37 |
Other Pre-specified
Change From Baseline in Free Testosterone
Free testosterone levels were calculated from total testosterone at screening and equilibrium dialysis at randomization and at trial end.
Time frame: Week 0, Week 14
Population: All available data expressed as absolute value at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone | Change From Baseline in Free Testosterone | Free Testosterone at week 0 | 110 pg/mL | Standard Deviation 79 |
| Testosterone | Change From Baseline in Free Testosterone | Free Testosterone at week 14 | 239 pg/mL | Standard Deviation 197 |
| Placebo | Change From Baseline in Free Testosterone | Free Testosterone at week 0 | 101 pg/mL | Standard Deviation 36 |
| Placebo | Change From Baseline in Free Testosterone | Free Testosterone at week 14 | 103 pg/mL | Standard Deviation 63 |
Other Pre-specified
Change From Baseline in Sex Hormone Binding Globulin (SHBG)
Time frame: Week 0, Week 14
Population: All available data expressed as absolute value at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone | Change From Baseline in Sex Hormone Binding Globulin (SHBG) | SHBG at week 0 | 32.2 nmol/L | Standard Deviation 14.7 |
| Testosterone | Change From Baseline in Sex Hormone Binding Globulin (SHBG) | SHBG at week 14 | 32 nmol/L | Standard Deviation 16 |
| Placebo | Change From Baseline in Sex Hormone Binding Globulin (SHBG) | SHBG at week 0 | 27.5 nmol/L | Standard Deviation 14.6 |
| Placebo | Change From Baseline in Sex Hormone Binding Globulin (SHBG) | SHBG at week 14 | 28 nmol/L | Standard Deviation 15 |
Other Pre-specified
Change From Baseline in Total Testosterone
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.
Time frame: Week 0, Week 14
Population: All available data expressed as absolute value at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone | Change From Baseline in Total Testosterone | Total Testosterone at week 0 | 364 ng/dL | Standard Deviation 192 |
| Testosterone | Change From Baseline in Total Testosterone | Total Testosterone at week 14 | 649 ng/dL | Standard Deviation 411 |
| Placebo | Change From Baseline in Total Testosterone | Total Testosterone at week 0 | 347 ng/dL | Standard Deviation 141 |
| Placebo | Change From Baseline in Total Testosterone | Total Testosterone at week 14 | 339 ng/dL | Standard Deviation 155 |