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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD047722-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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 The initial assessment will be made prior to treatment with sildenafil citrate, i.e., in subjects who are naïve to or withdrawn from PDE5 inhibitors and/or testosterone.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Testosterone Gel | Experimental | Active Testosterone Gel and 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. |
|
| Placebo Gel | Placebo Comparator | Placebo Gel and 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil citrate (open label) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0, week 8, week 11, week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0, Week 14 |
| Change From Baseline in Free Testosterone |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shalender Bhasin, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University Medical Center | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38224135 | Derived | Lee H, Hwang EC, Oh CK, Lee S, Yu HS, Lim JS, Kim HW, Walsh T, Kim MH, Jung JH, Dahm P. Testosterone replacement in men with sexual dysfunction. Cochrane Database Syst Rev. 2024 Jan 15;1(1):CD013071. doi: 10.1002/14651858.CD013071.pub2. | |
| 35790332 | Derived | Wilson E, Gannon H, Chimhini G, Fitzgerald F, Khan N, Lorencatto F, Kesler E, Nkhoma D, Chiyaka T, Haghparast-Bidgoli H, Lakhanpaul M, Cortina Borja M, Stevenson AG, Crehan C, Sassoon Y, Hull-Bailey T, Curtis K, Chiume M, Chimhuya S, Heys M. Protocol for an intervention development and pilot implementation evaluation study of an e-health solution to improve newborn care quality and survival in two low-resource settings, Malawi and Zimbabwe: Neotree. BMJ Open. 2022 Jul 5;12(7):e056605. doi: 10.1136/bmjopen-2021-056605. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristic are provided prior to sildenafil administration (week -7)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All available data expressed as absolute value at the given time-point. | Posted | Mean | Standard Deviation | units on a scale | Week 0, week 8, week 11, week 14 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shalender Bhasin | Brigham and Women's Hospital | 617-525-9150 | sbhasin@partners.org |
Not provided
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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|
|
| Testosterone gel | Drug | 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. |
|
|
| Placebo gel | Other | 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.. |
|
| Week 0, week 8, week 11, week 14 |
| 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. | Week 0, week 8, week 14 |
| 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. | Week 0, week 8, week 14 |
| 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. | Week 0, Week 8, Week 14 |
| 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. | Week 0, Week 8, Week 14 |
| 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. | Week 0, Week 8, Week 14 |
| 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. | Week 0, Week 8, Week 14 |
| 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. | Week 0, Week 8, Week 14 |
| 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. | Week 0, Week 8, Week 14 |
Free testosterone levels were calculated from total testosterone at screening and equilibrium dialysis at randomization and at trial end. |
| Week 0, Week 14 |
| Change From Baseline in Sex Hormone Binding Globulin (SHBG) | Week 0, Week 14 |
| 24106072 | Derived | Spitzer M, Bhasin S, Travison TG, Davda MN, Stroh H, Basaria S. Sildenafil increases serum testosterone levels by a direct action on the testes. Andrology. 2013 Nov;1(6):913-8. doi: 10.1111/j.2047-2927.2013.00131.x. Epub 2013 Sep 18. |
| 23494931 | Derived | Spitzer M, Basaria S, Travison TG, Davda MN, DeRogatis L, Bhasin S. The effect of testosterone on mood and well-being in men with erectile dysfunction in a randomized, placebo-controlled trial. Andrology. 2013 May;1(3):475-82. doi: 10.1111/j.2047-2927.2013.00075.x. Epub 2013 Mar 15. |
| 23165659 | Derived | Spitzer M, Basaria S, Travison TG, Davda MN, Paley A, Cohen B, Mazer NA, Knapp PE, Hanka S, Lakshman KM, Ulloor J, Zhang A, Orwoll K, Eder R, Collins L, Mohammed N, Rosen RC, DeRogatis L, Bhasin S. Effect of testosterone replacement on response to sildenafil citrate in men with erectile dysfunction: a parallel, randomized trial. Ann Intern Med. 2012 Nov 20;157(10):681-91. doi: 10.7326/0003-4819-157-10-201211200-00004. |
| Developed a hematocrit exceeding 0.54 |
|
| Unable to tolerate the smell of the gel |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Based on the number of participants who responded. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Cardiovascular disease | Count of Participants | Participants |
|
| Total testosterone level | Mean | Standard Deviation | ng/dL |
|
| Total testosterone level <250 ng/dL | Count of Participants | Participants |
|
| Free testosterone level | Mean | Standard Deviation | pg/mL |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| Sexual Encounter Profile (SEP) | Sexual Encounter Profile (SEP) diaries assesses 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. | Mean | Standard Deviation | events/week |
|
| Successful sexual Intercourse in Sexual Encounter Profile (SEP) | Sexual Encounter Profile (SEP) diaries assesses 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. | Mean | Standard Deviation | percentage of successful intercourse |
|
| Male 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. | Mean | Standard Deviation | units on a scale |
|
| 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. Scores were standardized to 0 to 100. Higher QOL-MED scores reflect better quality of life. | Mean | Standard Deviation | units on a scale |
|
| Marital Interaction scale in 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. | Mean | Standard Deviation | units on a scale |
|
| Psychological Global Well-Being Index (PGWBI) | PGWBI consists of 22 items each ranges from 0 (poor) to 5 (good) measuring Quality of Life (QoL). It measures 6 dimensions of perceived well-being and distress: Anxiety (5 questions), Depressed Mood (3 questions), Positive Well-Being (4 questions), Self Control (3 questions), General Health (3 questions), and Vitality (4 questions). An global score is the sum of 6 domains, ranging from 0 (poor QoL) to 110 (good QoL). The PGWBI global score and those of its 6 dimensions are normalized to 0-100. Higher score represents better QoL. | Mean | Standard Deviation | units on a scale |
|
| Derogatis Affects Balance Scale (DABS) | The DABS measures affectivity and affects balance via 4 positive (Joy, Contentment, Vigor, and Affection) and 4 negative (Anxiety, Depression, Guilt, and Hostility) dimensions that reflect basic emotional states. Each domain is scored separately from 0 to 20 with higher scores representing stronger emotional feeling. | Mean | Standard Deviation | units on a scale |
|
| Positive Affect Ratio (PAR) in Derogatis Affects Balance Scale (DABS) | The DABS measures affectivity and affects balance via 4 positive (Joy, Contentment, Vigor, and Affection) and 4 negative (Anxiety, Depression, Guilt, and Hostility) dimensions that reflect basic emotional states. 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. | Mean | Standard Deviation | ratios |
|
| OG001 | 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. |
|
|
| 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. | All available data expressed as absolute value at the given time-point. | Posted | Mean | Standard Deviation | units on a scale | Week 0, week 8, week 11, week 14 |
|
|
|
| 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. | All available data expressed as absolute value at the given time-point. | Posted | Mean | Standard Deviation | events/week | Week 0, week 8, week 14 |
|
|
|
| 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. | All available data expressed as absolute value at the given time-point. | Posted | Mean | Standard Deviation | percentage of sexual intercourses | Week 0, week 8, week 14 |
|
|
|
| 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. | All available data expressed as absolute value at the given time-point. | Posted | Mean | Standard Deviation | units on a scale | Week 0, Week 8, Week 14 |
|
|
|
| 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. | All available data expressed as absolute value at the given time-point. | Posted | Mean | Standard Deviation | units on a scale | Week 0, Week 8, Week 14 |
|
|
|
| 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. | All available data expressed as absolute value at the given time-point. | Posted | Mean | Standard Deviation | units on a scale | Week 0, Week 8, Week 14 |
|
|
|
| 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. | All available data expressed as absolute value at the given time-point. | Posted | Mean | Standard Deviation | units on a scale | Week 0, Week 8, Week 14 |
|
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| 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. | All available data expressed as absolute value at the given time-point. | Posted | Mean | Standard Deviation | units on a scale | Week 0, Week 8, Week 14 |
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| 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. | All available data expressed as absolute value at the given time-point. | Posted | Mean | Standard Deviation | ratios | Week 0, Week 8, Week 14 |
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| 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. | All available data expressed as absolute value at the given time-point. | Posted | Mean | Standard Deviation | ng/dL | Week 0, Week 14 |
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| 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. | All available data expressed as absolute value at the given time-point. | Posted | Mean | Standard Deviation | pg/mL | Week 0, Week 14 |
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| Other Pre-specified | Change From Baseline in Sex Hormone Binding Globulin (SHBG) | All available data expressed as absolute value at the given time-point. | Posted | Mean | Standard Deviation | nmol/L | Week 0, Week 14 |
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| 0 |
| 70 |
| 2 |
| 70 |
| 27 |
| 70 |
| EG001 | 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. | 0 | 70 | 4 | 70 | 13 | 70 |
| Acute cholecystitis | Hepatobiliary disorders | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Incisional hernia repair | Surgical and medical procedures | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Chills | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | Systematic Assessment |
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| Keen pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Tooth ache | Gastrointestinal disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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Not provided
Not provided
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Other |
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| Orgasmic function at week 8 |
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| Orgasmic function at week 11 |
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| Orgasmic function at week 14 |
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| Sexual desire at week 0 |
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| Sexual desire at week 8 |
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| Sexual desire at week 11 |
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| Sexual desire at week 14 |
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| Intercourse satisfaction at week 0 |
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| Intercourse satisfaction at week 8 |
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| Intercourse satisfaction at week 11 |
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| Intercourse satisfaction at week 14 |
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| Overall satisfaction at week 0 |
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| Overall satisfaction at week 8 |
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| Overall satisfaction at week 11 |
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| Overall satisfaction at week 14 |
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| Composite IIEF at week 0 |
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| Composite IIEF at week 8 |
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| Composite IIEF at week 11 |
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| Composite IIEF at week 14 |
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| Sexual Encounter Attempts at week 8 |
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| Sexual Encounter Attempts at week 14 |
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| Vaginal Penetration at week 0 |
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| Vaginal Penetration at week 8 |
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| Vaginal Penetration at week 14 |
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| Ejaculation at week 0 |
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| Ejaculation at week 8 |
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| Ejaculation at week 14 |
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| Overall Satisfied with Sexual Encounters at week0 |
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| Overall Satisfied with Sexual Encounters at week8 |
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| Overall Satisfied with Sexual Encounters at wk 14 |
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| Successful Sexual Intercourse (Ejaculations) wk8 |
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| Successful Sexual Intercourse (Ejaculations)wk14 |
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| Successful Sexual Intercourse (Satisfaction) wk0 |
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| Successful Sexual Intercourse (Satisfaction) wk8 |
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| Successful Sexual Intercourse (Satisfaction)wk14 |
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| Erectile at week 8 |
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| Erectile at week 14 |
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| Ejaculation at week 0 |
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| Ejaculation at week 8 |
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| Ejaculation at week 14 |
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| Sexual satisfaction at week 0 |
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| Sexual satisfaction at week 8 |
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| Sexual satisfaction at week 14 |
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| Sexual desire at week 0 |
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| Sexual desire at week 8 |
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| Sexual desire at week 14 |
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| Sexual activity at week 0 |
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| Sexual activity at week 8 |
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| Sexual activity at week 14 |
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| Composite MSHQ at week 0 |
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| Composite MSHQ at week 8 |
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| Composite MSHQ at week 14 |
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| QOL-MED scale at week 8 |
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| QOL-MED scale at week 14 |
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| CARES-SF: Marital relationship at week 8 |
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| CARES-SF: Marital relationship at week 14 |
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| Positive Well-being at week 8 |
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| Positive Well-being at week 14 |
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| Depressed Mood at week 0 |
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| Depressed Mood at week 8 |
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| Depressed Mood at week 14 |
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| General Health at week 0 |
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| General Health at week 8 |
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| General Health at week 14 |
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| Anxiety at week 0 |
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| Anxiety at week 8 |
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| Anxiety at week 14 |
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| Self Control at week 0 |
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| Self Control at week 8 |
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| Self Control at week 14 |
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| Vitality at week 0 |
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| Vitality at week 8 |
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| Vitality at week 14 |
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| Global Score at week 0 |
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| Global Score at week 8 |
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| Global Score at week 14 |
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| Joy at week 8 |
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| Joy at week 14 |
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| Contentment at week 0 |
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| Contentment at week 8 |
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| Contentment at week 14 |
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| Vigor at week 0 |
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| Vigor at week 8 |
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| Vigor at week 14 |
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| Affection at week 0 |
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| Affection at week 8 |
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| Affection at week 14 |
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| Depression at week 0 |
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| Depression at week 8 |
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| Depression at week 14 |
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| Anxiety at week 0 |
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| Anxiety at week 8 |
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| Anxiety at week 14 |
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| Guilt at week 0 |
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| Guilt at week 8 |
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| Guilt at week 14 |
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| Hostility at week 0 |
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| Hostility at week 8 |
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| Hostility at week 14 |
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| Positive Affect Ratio at week 8 |
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| Positive Affect Ratio at week 14 |
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| Total Testosterone at week 14 |
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| Free Testosterone at week 14 |
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| SHBG at week 14 |
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