Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This research study is studying the use of a targeted therapy called LY SARM, which is an investigational drug from a new class of molecules called Selective Androgen Receptor Modulators (SARMs) as a possible improvement in quality of life for participants who have undergone radical prostatectomy. Androgens are a group of hormones that play a role in male traits and reproductive activity.
The names of the study interventions involved in this study are:
- LY2452473
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved LY SARM/LY2452473 as a treatment for any disease.
In this research study, the investigators are studying a new investigational drug called LY SARM (LY2452473). Concerns about the potential adverse effects of testosterone on the prostate have led to the development of molecules called SARMs (Selective Androgen Receptor Modulators). This investigational drug may improve sexual function, quality of life, muscle and bone mass in men with prostate cancer. This molecule was chosen because there is some evidence that shows it may help to improve sexual function and aid in the improvement of muscle mass while not having any influence on the prostate.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1, LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle. |
|
| LY2452473 Dose 1 | Active Comparator | Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1, LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle. |
|
| LY2452473 Dose 2 | Active Comparator | Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1 or LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle. |
|
| LY2452473 Dose 3 | Active Comparator | Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1, LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2452473 | Drug | LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4) | The primary outcome is change in sexual activity score, assessed by the Psychosexual Daily Questionnaire (PDQ). The questionnaire covered 3 different domains: 1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual activity was assessed using a checklist format (12-item) and the score range of 0 to 12 with higher scores representing better sexual activity. | 12 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in All 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. |
Not provided
Inclusion Criteria
Age 19 years of age or older
History of prostate cancer
Serum testosterone, measured by Liquid chromatography-tandem mass spectrometry (LC-MS/MS), <300 mg/dL and/or free testosterone by equilibrium dialysis <60 pg/mL.
* Derogatis Index of Sexual Function Male II (DISF-M-II) score ≤20, fatigue (FACIT-F score <30), or physical dysfunction (self-reported difficulty in walking a 1/4 mile or climbing two flights of stairs, short physical performance battery score 4 to 9).
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shalender Bhasin, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States | ||
| John Hopkins Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34019661 | Derived | Pencina KM, Burnett AL, Storer TW, Guo W, Li Z, Kibel AS, Huang G, Blouin M, Berry DL, Basaria S, Bhasin S. A Selective Androgen Receptor Modulator (OPK-88004) in Prostate Cancer Survivors: A Randomized Trial. J Clin Endocrinol Metab. 2021 Jul 13;106(8):2171-2186. doi: 10.1210/clinem/dgab361. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. |
| FG001 | LY2452473 Dose 1 | The participants will receive 1 mg LY2452473 daily for 12-weeks. N-[(2S)-7-cyano-1,2,3,4-tetrahydro-4-(2-pyridinylmethyl)cyclopent[b]indol-2-yl]-,1-methylester (LY2452473): LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate. |
| FG002 | LY2452473 Dose 2 | The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate. |
| FG003 | LY2452473 Dose 3 | The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. |
| BG001 | LY2452473 Dose 1 | The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate. |
| 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 in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4) | The primary outcome is change in sexual activity score, assessed by the Psychosexual Daily Questionnaire (PDQ). The questionnaire covered 3 different domains: 1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual activity was assessed using a checklist format (12-item) and the score range of 0 to 12 with higher scores representing better sexual activity. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | units on a scale | 12 weeks from baseline |
|
12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery bypass | Surgical and medical procedures | MedDRA (24.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shalender Bhasin, Principal Investigator | Brigham and Women's hospital | 617 525 9150 | sbhasin@bwh.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2019 | Aug 20, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C582633 | LY2452473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | The participants will receive pills containing no active drug. |
|
|
| 12 weeks from baseline |
| Change in Sexual Activity, Interest, and Desire Scale (SAID) | The Sexual Activity, Interest, and Desire Scale (SAID) is an 8-item questionnaire that evaluates 3 response domains, including sexual thinking, sexual arousal, and sexual activity. The score was linearly transformed to a 0 to 100 scale for each item. The average score ranges 0-100. The higher the score, the better the sexual function. | 12 weeks from baseline |
| Change in Derogatis Index of Sexual Function Male II (DISF-M-II) | Derogatis Index of Sexual Function Male II (DISF-M-II) is a 25-item questionnaire that provides an estimate of perceived quality of sexual activities in 5 response domains: sexual desire/drive (range 0-33), sexual arousal (range 0-33), sexual activity (range 0-35), orgasm (range 0-26), and sexual satisfaction/partner relationship (range 0-25). The total possible score (sum of 5 domains) range of 0 to 152 with higher scores representing better function. | 12 weeks from baseline |
| Change in Three Domains of Men's Sexual Health Questionnaire (MSHQ) | Men's Sexual Health Questionnaire (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)). Erection, Ejaculation and Satisfaction domains were measured and the higher score representing better sexual function and satisfaction. | 12 weeks from baseline |
| Change in Two Domains of Expanded Prostate Cancer Index Composite (EPIC) | Expanded Prostate Cancer Index Composite (EPIC) is a 50-item, comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Of its four domains, the sexual domain (range 0-100) and hormonal domain (range 0-100) were utilized. The response for each item is standardized to a 0 to 100 scale. Higher score yields better quality of life. | 12 weeks from baseline |
| Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | The FACIT Fatigue Scale is a 13-item questionnaire that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point scale (4 = not at all fatigued to 0 = very much fatigued). Score ranges 0-52. The higher the score, the better the quality of life. | 12 weeks from baseline |
| Change in Hypogonadism Energy Diary (HED) | Hypogonadism Energy Diary (HED) is a 4-item questionnaire that intended to assess real-time energy levels. Score ranges 0 to100 with higher scores representing higher energy. each question uses an 11-point numerical rating scale (0-10) with 10 corresponding to full of energy or extreme tiredness. HED score was the average of the scores for these 4 items. Scores were linearly transformed to a 0 to 100 scale. Higher scores representing higher energy. | 12 weeks from baseline |
| Change in International Prostate Symptom Score (IPSS) | International Prostate Symptom Score (IPSS) is a 8-item, extensively validated and widely used self-reported measure of lower urinary tract symptoms questionnaire. It includes Urinary Symptoms (item1-7, range 0-35) and Quality of Life Due to Urinary Symptoms (item 8, range 0-6). The higher the score, the severer of the urinary symptoms and worse quality of life due to symptoms. | 12 weeks from baseline |
| Change in Positive and Negative Affect Scale (PANAS) | The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (very slightly or not at all) to 5 (extremely). Score ranges 10-50 for both positive and negative affect. The higher scores represent higher levels of positive/negative affect. | 12 weeks from baseline |
| Change in Body Mass Using DXA | Whole body, appendicular, and trunk lean mass were measured using dual energy X- ray absorptiometry (DXA), calibrated using a soft tissue phantom before each scan. | 12 weeks from baseline |
| Change of Maximal Voluntary Muscle Strength | The maximal voluntary muscle strength was measured in the leg press exercise using the 1-repetition method | 12 weeks from baseline |
| Change in Gait Speed in 6-minute Walk | Tests of Physical Function and Task-Specific Performance measured by gait speed in 6-min walk | 12 weeks from baseline |
| Change of 50 Meters Walk Tests- Unloaded /Loaded | Tests of Physical Function and Task-Specific Performance measured by 50-meter timed walk + 20% load carry. Physical Function was evaluated using test of 50-meter loaded walking speed. One test consisted of walking 50 meters as rapidly as possible without running (unloaded) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags(loaded). Time was measured electronically with a digital clock. Speed in meters per second is calculated by the following: 50/time. | 12 weeks from baseline |
| Change in Power of Stair Climbing Tests- Unloaded/Loaded | Tests of Physical Function and Task-Specific Performance measured by Stair-climbing power +/- 20% load carry. Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: [body weight (kilograms) * distance (meters)/ (time/60)] /6.12. | 12 weeks from baseline |
| Change in Serum Total Testosterone Level | Serum total testosterone levels during screening was measured in the Quest Diagnostics Laboratory, Chantilly, VA, using liquid chromatography tandem mass spectrometry (LC-MS/MS) method certified by the Hormone Standardization Program for Testosterone (HoST) of the Centers for Disease Control and Prevention, Atlanta, Georgia. | 12 weeks from baseline |
| Change in Free Testosterone Level | Free testosterone level for screening was measured using an equilibrium dialysis method. | 12 weeks from baseline |
| Change in Serum Sex Hormone-binding Globulin (SHBG) Level | Serum SHBG level was measured using two-site directed immuno-chemiluminescence assays with sensitivity 2.5 nmol/L, and coefficients of variation less than 10% in low, medium and high range | 12 weeks from baseline |
| Change in Serum Luteinizing Hormone (LH) Level | Serum LH level was measured using two-site directed immuno-chemiluminescence assays with sensitivity 0.1 U/L, and coefficients of variation less than 10% in low, medium and high range | 12 weeks from baseline |
| Change in Estradiol Levels | Estradiol level was measured by LC-MS/MS. | 12 weeks from baseline |
| Change of White Blood Cell | White Blood Cell was measured for safety monitoring. | 12 weeks from baseline |
| Change of Red Blood Cell | Red Blood Cell was measured for safety monitoring. | 12 weeks from baseline |
| Change in Hematocrit | Hematocrit was measured for safety monitoring. | 12 weeks from baseline |
| Change in Hemoglobin | Hemoglobin was measured for safety monitoring. | 12 weeks from baseline |
| Change of Mean Corpuscular Volume (MCV) | Mean corpuscular volume was measured for safety monitoring. | 12 weeks from baseline |
| Change of Red Blood Cell Distribution Width (RDW) | Red blood cell distribution width (RDW) was measured for safety monitoring. RDW was calculated with: standard deviation of the mean cell size divided by the mean corpuscular volume of the red cells multiplied by 100 | 12 weeks from baseline |
| Change in Platelet Count | Platelet count was measured for safety monitoring. | 12 weeks from baseline |
| Change of Aspartate Aminotransferase (AST) | Aspartate aminotransferase was measured for safety monitoring. | 12 weeks from baseline |
| Change of Alanine Aminotransferase (ALT) | Alanine aminotransferase was measured for safety monitoring. | 12 weeks from baseline |
| Change of Total Bilirubin | Total Bilirubin was measured for safety monitoring. | 12 weeks from baseline |
| Change in Serum Alkaline Phosphatase | Serum alkaline phosphatase was measured for safety monitoring. | 12 weeks from baseline |
| Change of Lipid Panel | Plasma lipids were measured for safety monitoring. | 12 weeks from baseline |
| Change in Fasting Glucose Levels | Glucose will be measured in a fasting serum sample at Quest Lab. | 12 weeks from baseline |
| Change in Insulin | Insulin will be measured using an immunoassay at Quest lab. | 12 weeks from baseline |
| Baltimore |
| Maryland |
| 21231 |
| United States |
| Beth Israel Deaconess Medical Center (Referring site only) | Boston | Massachusetts | 02115 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| BG002 | LY2452473 Dose 2 | The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate. |
| BG003 | LY2452473 Dose 3 | The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Short Physical Performance Battery (SPPB) score | The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. The scores range from 0 to 12. The higher the score, the better the performance. | Mean | Standard Deviation | units on a scale |
|
| LY2452473 Dose 1 |
The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate. |
| OG002 | LY2452473 Dose 2 | The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate. |
| OG003 | LY2452473 Dose 3 | The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate. |
|
|
| Secondary | Change in All 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 randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | units on a scale | 12 weeks from baseline |
|
|
|
| Secondary | Change in Sexual Activity, Interest, and Desire Scale (SAID) | The Sexual Activity, Interest, and Desire Scale (SAID) is an 8-item questionnaire that evaluates 3 response domains, including sexual thinking, sexual arousal, and sexual activity. The score was linearly transformed to a 0 to 100 scale for each item. The average score ranges 0-100. The higher the score, the better the sexual function. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | units on a scale | 12 weeks from baseline |
|
|
|
| Secondary | Change in Derogatis Index of Sexual Function Male II (DISF-M-II) | Derogatis Index of Sexual Function Male II (DISF-M-II) is a 25-item questionnaire that provides an estimate of perceived quality of sexual activities in 5 response domains: sexual desire/drive (range 0-33), sexual arousal (range 0-33), sexual activity (range 0-35), orgasm (range 0-26), and sexual satisfaction/partner relationship (range 0-25). The total possible score (sum of 5 domains) range of 0 to 152 with higher scores representing better function. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | units on a scale | 12 weeks from baseline |
|
|
|
| Secondary | Change in Three Domains of Men's Sexual Health Questionnaire (MSHQ) | Men's Sexual Health Questionnaire (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)). Erection, Ejaculation and Satisfaction domains were measured and the higher score representing better sexual function and satisfaction. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | units on a scale | 12 weeks from baseline |
|
|
|
| Secondary | Change in Two Domains of Expanded Prostate Cancer Index Composite (EPIC) | Expanded Prostate Cancer Index Composite (EPIC) is a 50-item, comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Of its four domains, the sexual domain (range 0-100) and hormonal domain (range 0-100) were utilized. The response for each item is standardized to a 0 to 100 scale. Higher score yields better quality of life. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | units on a scale | 12 weeks from baseline |
|
|
|
| Secondary | Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | The FACIT Fatigue Scale is a 13-item questionnaire that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point scale (4 = not at all fatigued to 0 = very much fatigued). Score ranges 0-52. The higher the score, the better the quality of life. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | units on a scale | 12 weeks from baseline |
|
|
|
| Secondary | Change in Hypogonadism Energy Diary (HED) | Hypogonadism Energy Diary (HED) is a 4-item questionnaire that intended to assess real-time energy levels. Score ranges 0 to100 with higher scores representing higher energy. each question uses an 11-point numerical rating scale (0-10) with 10 corresponding to full of energy or extreme tiredness. HED score was the average of the scores for these 4 items. Scores were linearly transformed to a 0 to 100 scale. Higher scores representing higher energy. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | units on a scale | 12 weeks from baseline |
|
|
|
| Secondary | Change in International Prostate Symptom Score (IPSS) | International Prostate Symptom Score (IPSS) is a 8-item, extensively validated and widely used self-reported measure of lower urinary tract symptoms questionnaire. It includes Urinary Symptoms (item1-7, range 0-35) and Quality of Life Due to Urinary Symptoms (item 8, range 0-6). The higher the score, the severer of the urinary symptoms and worse quality of life due to symptoms. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | units on a scale | 12 weeks from baseline |
|
|
|
| Secondary | Change in Positive and Negative Affect Scale (PANAS) | The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (very slightly or not at all) to 5 (extremely). Score ranges 10-50 for both positive and negative affect. The higher scores represent higher levels of positive/negative affect. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | units on a scale | 12 weeks from baseline |
|
|
|
| Secondary | Change in Body Mass Using DXA | Whole body, appendicular, and trunk lean mass were measured using dual energy X- ray absorptiometry (DXA), calibrated using a soft tissue phantom before each scan. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | kg | 12 weeks from baseline |
|
|
|
| Secondary | Change of Maximal Voluntary Muscle Strength | The maximal voluntary muscle strength was measured in the leg press exercise using the 1-repetition method | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | N | 12 weeks from baseline |
|
|
|
| Secondary | Change in Gait Speed in 6-minute Walk | Tests of Physical Function and Task-Specific Performance measured by gait speed in 6-min walk | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | m/sec | 12 weeks from baseline |
|
|
|
| Secondary | Change of 50 Meters Walk Tests- Unloaded /Loaded | Tests of Physical Function and Task-Specific Performance measured by 50-meter timed walk + 20% load carry. Physical Function was evaluated using test of 50-meter loaded walking speed. One test consisted of walking 50 meters as rapidly as possible without running (unloaded) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags(loaded). Time was measured electronically with a digital clock. Speed in meters per second is calculated by the following: 50/time. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | m/sec | 12 weeks from baseline |
|
|
|
| Secondary | Change in Power of Stair Climbing Tests- Unloaded/Loaded | Tests of Physical Function and Task-Specific Performance measured by Stair-climbing power +/- 20% load carry. Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: [body weight (kilograms) * distance (meters)/ (time/60)] /6.12. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | watts | 12 weeks from baseline |
|
|
|
| Secondary | Change in Serum Total Testosterone Level | Serum total testosterone levels during screening was measured in the Quest Diagnostics Laboratory, Chantilly, VA, using liquid chromatography tandem mass spectrometry (LC-MS/MS) method certified by the Hormone Standardization Program for Testosterone (HoST) of the Centers for Disease Control and Prevention, Atlanta, Georgia. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | ng/dL | 12 weeks from baseline |
|
|
|
| Secondary | Change in Free Testosterone Level | Free testosterone level for screening was measured using an equilibrium dialysis method. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | pg/mL | 12 weeks from baseline |
|
|
|
| Secondary | Change in Serum Sex Hormone-binding Globulin (SHBG) Level | Serum SHBG level was measured using two-site directed immuno-chemiluminescence assays with sensitivity 2.5 nmol/L, and coefficients of variation less than 10% in low, medium and high range | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | nmol/L | 12 weeks from baseline |
|
|
|
| Secondary | Change in Serum Luteinizing Hormone (LH) Level | Serum LH level was measured using two-site directed immuno-chemiluminescence assays with sensitivity 0.1 U/L, and coefficients of variation less than 10% in low, medium and high range | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | mIU/mL | 12 weeks from baseline |
|
|
|
| Secondary | Change in Estradiol Levels | Estradiol level was measured by LC-MS/MS. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | pg/mL | 12 weeks from baseline |
|
|
|
| Secondary | Change of White Blood Cell | White Blood Cell was measured for safety monitoring. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | K/uL | 12 weeks from baseline |
|
|
|
| Secondary | Change of Red Blood Cell | Red Blood Cell was measured for safety monitoring. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | K/uL | 12 weeks from baseline |
|
|
|
| Secondary | Change in Hematocrit | Hematocrit was measured for safety monitoring. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | percentage of volume of red cells | 12 weeks from baseline |
|
|
|
| Secondary | Change in Hemoglobin | Hemoglobin was measured for safety monitoring. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | g/dL | 12 weeks from baseline |
|
|
|
| Secondary | Change of Mean Corpuscular Volume (MCV) | Mean corpuscular volume was measured for safety monitoring. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | fL | 12 weeks from baseline |
|
|
|
| Secondary | Change of Red Blood Cell Distribution Width (RDW) | Red blood cell distribution width (RDW) was measured for safety monitoring. RDW was calculated with: standard deviation of the mean cell size divided by the mean corpuscular volume of the red cells multiplied by 100 | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | percentage of variation of red cells | 12 weeks from baseline |
|
|
|
| Secondary | Change in Platelet Count | Platelet count was measured for safety monitoring. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | K/uL | 12 weeks from baseline |
|
|
|
| Secondary | Change of Aspartate Aminotransferase (AST) | Aspartate aminotransferase was measured for safety monitoring. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | U/L | 12 weeks from baseline |
|
|
|
| Secondary | Change of Alanine Aminotransferase (ALT) | Alanine aminotransferase was measured for safety monitoring. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | U/L | 12 weeks from baseline |
|
|
|
| Secondary | Change of Total Bilirubin | Total Bilirubin was measured for safety monitoring. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | mg/dL | 12 weeks from baseline |
|
|
|
| Secondary | Change in Serum Alkaline Phosphatase | Serum alkaline phosphatase was measured for safety monitoring. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | U/L | 12 weeks from baseline |
|
|
|
| Secondary | Change of Lipid Panel | Plasma lipids were measured for safety monitoring. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | mg/dL | 12 weeks from baseline |
|
|
|
| Secondary | Change in Fasting Glucose Levels | Glucose will be measured in a fasting serum sample at Quest Lab. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | mg/dL | 12 weeks from baseline |
|
|
|
| Secondary | Change in Insulin | Insulin will be measured using an immunoassay at Quest lab. | All randomized and treated participants with data available at the given time-point. | Posted | Mean | Standard Error | uIU/mL | 12 weeks from baseline |
|
|
|
| 0 |
| 36 |
| 2 |
| 36 |
| 33 |
| 36 |
| EG001 | LY2452473 Dose 1 | The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate. | 0 | 28 | 2 | 28 | 22 | 28 |
| EG002 | LY2452473 Dose 2 | The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate. | 0 | 36 | 1 | 36 | 33 | 36 |
| EG003 | LY2452473 Dose 3 | The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate. | 0 | 14 | 1 | 14 | 10 | 14 |
| Myocardial infarction | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Metastatic ocular melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
|
| Renal Cancer | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Chest discomfort | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dizziness | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Diabetes mellitus | Endocrine disorders | MedDRA (24.0) | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA (24.0) | Systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA (24.0) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (24.0) | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
|
| Eye haemorrhage | Eye disorders | MedDRA (24.0) | Systematic Assessment |
|
| Iritis | Eye disorders | MedDRA (24.0) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (24.0) | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (24.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (24.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Oesophageal food impaction | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Swollen tongue | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Decreased appetite | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Increased appetite | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Night sweats | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Lyme Disease | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Norovirus infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Hand injury | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Palate injury | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Biopsy skin | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Blood iron decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Electrocardiogram ST segment depression | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
|
| Ankle impingement | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Ligament sprain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Muscle strain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Sciatica | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Cancer fatigue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
|
| Cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
|
| Renal cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
|
| Thyroid cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Micturition disorder | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Scrotal pain | Reproductive system and breast disorders | MedDRA (24.0) | Systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | MedDRA (24.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Abdominal pain | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Basal cell carcinoma | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Skin abrasion | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Skin laceration | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA (24.0) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Male |
|
| Intercourse satisfaction |
|
| Orgasmic function |
|
| Sexual desire |
|
| Overall satisfaction |
|
| Composite IIEF |
|
| Sexual Arousal |
|
| Sexual Activity |
|
| Orgasm |
|
| Sexual Satisfaction |
|
| Composite DISF-M-II |
|
|
| Ejaculation |
|
|
| Satisfaction |
|
|
|
| Hormonal function |
|
|
|
| Quality of Life Due to Urinary Symptoms |
|
|
| Negative Affect |
|
| Trunk Fat Mass |
|
| Total Fat Mass |
|
| Appendicular Lean Mass |
|
| Trunk Lean Mass |
|
| Total Lean Mass |
|
|
| Loaded |
|
|
|
| Loaded |
|
|
| HDL |
|
| LDL |
|
| Triglycerides |
|