A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
Study Details
Study Description
Brief Summary
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: Placebo 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. |
Drug: Placebo
The participants will receive pills containing no active drug.
Other Names:
|
Active Comparator: LY2452473 Dose 1 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. |
Drug: LY2452473
LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Other Names:
|
Active Comparator: LY2452473 Dose 2 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. |
Drug: LY2452473
LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Other Names:
|
Active Comparator: LY2452473 Dose 3 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. |
Drug: LY2452473
LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4) [12 weeks from baseline]
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.
Secondary Outcome Measures
- Change in All Domains of International Index of Erectile Function (IIEF) [12 weeks from baseline]
IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.
- Change in Sexual Activity, Interest, and Desire Scale (SAID) [12 weeks from baseline]
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.
- Change in Derogatis Index of Sexual Function Male II (DISF-M-II) [12 weeks from baseline]
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.
- Change in Three Domains of Men's Sexual Health Questionnaire (MSHQ) [12 weeks from baseline]
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.
- Change in Two Domains of Expanded Prostate Cancer Index Composite (EPIC) [12 weeks from baseline]
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.
- Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale [12 weeks from baseline]
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.
- Change in Hypogonadism Energy Diary (HED) [12 weeks from baseline]
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.
- Change in International Prostate Symptom Score (IPSS) [12 weeks from baseline]
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.
- Change in Positive and Negative Affect Scale (PANAS) [12 weeks from baseline]
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.
- Change in Body Mass Using DXA [12 weeks from baseline]
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.
- Change of Maximal Voluntary Muscle Strength [12 weeks from baseline]
The maximal voluntary muscle strength was measured in the leg press exercise using the 1-repetition method
- Change in Gait Speed in 6-minute Walk [12 weeks from baseline]
Tests of Physical Function and Task-Specific Performance measured by gait speed in 6-min walk
- Change of 50 Meters Walk Tests- Unloaded /Loaded [12 weeks from baseline]
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.
- Change in Power of Stair Climbing Tests- Unloaded/Loaded [12 weeks from baseline]
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.
- Change in Serum Total Testosterone Level [12 weeks from baseline]
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.
- Change in Free Testosterone Level [12 weeks from baseline]
Free testosterone level for screening was measured using an equilibrium dialysis method.
- Change in Serum Sex Hormone-binding Globulin (SHBG) Level [12 weeks from baseline]
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
- Change in Serum Luteinizing Hormone (LH) Level [12 weeks from baseline]
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
- Change in Estradiol Levels [12 weeks from baseline]
Estradiol level was measured by LC-MS/MS.
- Change of White Blood Cell [12 weeks from baseline]
White Blood Cell was measured for safety monitoring.
- Change of Red Blood Cell [12 weeks from baseline]
Red Blood Cell was measured for safety monitoring.
- Change in Hematocrit [12 weeks from baseline]
Hematocrit was measured for safety monitoring.
- Change in Hemoglobin [12 weeks from baseline]
Hemoglobin was measured for safety monitoring.
- Change of Mean Corpuscular Volume (MCV) [12 weeks from baseline]
Mean corpuscular volume was measured for safety monitoring.
- Change of Red Blood Cell Distribution Width (RDW) [12 weeks from baseline]
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
- Change in Platelet Count [12 weeks from baseline]
Platelet count was measured for safety monitoring.
- Change of Aspartate Aminotransferase (AST) [12 weeks from baseline]
Aspartate aminotransferase was measured for safety monitoring.
- Change of Alanine Aminotransferase (ALT) [12 weeks from baseline]
Alanine aminotransferase was measured for safety monitoring.
- Change of Total Bilirubin [12 weeks from baseline]
Total Bilirubin was measured for safety monitoring.
- Change in Serum Alkaline Phosphatase [12 weeks from baseline]
Serum alkaline phosphatase was measured for safety monitoring.
- Change of Lipid Panel [12 weeks from baseline]
Plasma lipids were measured for safety monitoring.
- Change in Fasting Glucose Levels [12 weeks from baseline]
Glucose will be measured in a fasting serum sample at Quest Lab.
- Change in Insulin [12 weeks from baseline]
Insulin will be measured using an immunoassay at Quest lab.
Eligibility Criteria
Criteria
Inclusion Criteria
-
Age 19 years of age or older
-
History of prostate cancer
-
Stage pathological tumor-2 (pT2) N0, M0 lesions (If American Joint Committee on Cancer (AJCC) staging is not available in medical records, the investigators will infer the staging based on extensive review of the pathology report)
-
Combined Gleason score < 7 (3+4)
-
Radical prostatectomy two or more years ago
-
Preoperative prostate-specific antigen (PSA)<10 ng/ml (if pre-operative PSA is not available in medical records, low-risk subjects with a Gleason score of 6(3+3) and who are at least 5 years out of surgery will be considered for enrollment)
-
PSA <0.1 ng/mL using an assay that has a functional sensitivity of 0.1 ng/mL for at least two years after radical prostatectomy
-
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.
-
Agree to use adequate contraception prior to receiving the study drug, for the duration of study participation, and 4 months after completion of LY SARM administration.
Exclusion Criteria
-
History of radiation monotherapy
-
History of androgen deprivation therapy
-
Use of testosterone, dehydroepiandrosterone (DHEA), estrogens, gonadotropin-releasing hormone (GnRH) analogs, antiandrogens, spironolactone, ketoconazole, recombinant human growth hormone (rhGH), or megestrol acetate within the past 6 months
-
Use of prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks within the past 6 months
-
Use of Clarithromycin, telithromycin, chloramphenicol, itraconazole, nefazodone, cobicistat within the past 6 months
-
Use of penile implants, vacuum pump devices, intra-cavernosal injections
-
Hematocrit >50%
-
Serum creatinine >2.5 mg/dL
-
Aspartate aminotransferase (AST) greater than 3x upper limit of normal (ULN)
-
Alanine aminotransferase (ALT) greater than 3x ULN
-
Hemoglobin A1c >7.5%
-
Body mass index (BMI) >40 kg/m2
-
Diabetes requiring insulin therapy
-
Severe untreated sleep apnea (treatment is defined as therapy with continuous positive airway pressure (CPAP), BiPAP, adaptive servo-ventilation (ASV), or other positive air pressure device)
-
Uncontrolled heart failure (NYHA class 3 or 4)
-
History of HIV
-
Myocardial infarction within the last 3 months
-
Acute coronary syndrome within the last 3 months
-
Revascularization surgery within the last 3 months
-
Stroke within the last 3 months
-
Diagnosed schizophrenia or bipolar disorder or untreated depression
-
Not appropriate for study based on physician discretion
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Florida | Gainesville | Florida | United States | 32611 |
2 | John Hopkins Medical Center | Baltimore | Maryland | United States | 21231 |
3 | Beth Israel Deaconess Medical Center (Referring site only) | Boston | Massachusetts | United States | 02115 |
4 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Dana-Farber Cancer Institute
- National Institute of Nursing Research (NINR)
Investigators
- Principal Investigator: Shalender Bhasin, MD, Brigham and Women's Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.- 15-120
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Period Title: Overall Study | ||||
STARTED | 36 | 28 | 36 | 14 |
COMPLETED | 32 | 22 | 35 | 13 |
NOT COMPLETED | 4 | 6 | 1 | 1 |
Baseline Characteristics
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 | Total |
---|---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. | Total of all reporting groups |
Overall Participants | 36 | 28 | 36 | 14 | 114 |
Age (years) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [years] |
67.1
(6.1)
|
67.1
(7.87)
|
67.4
(8.6)
|
69.6
(7.1)
|
67.5
(7.5)
|
Sex: Female, Male (Count of Participants) | |||||
Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Male |
36
100%
|
28
100%
|
36
100%
|
14
100%
|
114
100%
|
Race and Ethnicity Not Collected (Count of Participants) | |||||
Count of Participants [Participants] |
0
0%
|
||||
Region of Enrollment (Count of Participants) | |||||
United States |
36
100%
|
28
100%
|
36
100%
|
14
100%
|
114
100%
|
Weight (kg) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [kg] |
84.9
(12.7)
|
92.7
(10.7)
|
89.7
(15.4)
|
86.7
(12.5)
|
88.5
(13.4)
|
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [kg/m^2] |
27.9
(3.8)
|
29.8
(3.89)
|
29.3
(4.1)
|
29.2
(5.1)
|
29.0
(4.1)
|
Short Physical Performance Battery (SPPB) score (units on a scale) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [units on a scale] |
11.4
(1.15)
|
11.1
(1.21)
|
11.1
(1.42)
|
11.1
(1.07)
|
11.2
(1.24)
|
Outcome Measures
Title | Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4) |
---|---|
Description | 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. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 28 | 23 | 35 | 13 |
Mean (Standard Error) [units on a scale] |
0.04
(0.19)
|
0.45
(0.26)
|
-0.02
(0.22)
|
0.12
(0.27)
|
Title | Change in All Domains of International Index of Erectile Function (IIEF) |
---|---|
Description | IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 12 |
Erectile Function |
2.34
(1.02)
|
0.92
(0.48)
|
-0.50
(0.94)
|
3.38
(2.83)
|
Intercourse satisfaction |
0.97
(0.50)
|
0.42
(0.25)
|
-0.22
(0.39)
|
0.92
(1.59)
|
Orgasmic function |
0.12
(0.48)
|
0.17
(0.32)
|
-0.53
(0.57)
|
0.75
(0.85)
|
Sexual desire |
0.30
(0.22)
|
0.46
(0.38)
|
-0.19
(0.25)
|
0.83
(0.61)
|
Overall satisfaction |
1.13
(0.34)
|
0.79
(0.32)
|
0.31
(0.33)
|
0.25
(0.70)
|
Composite IIEF |
4.79
(1.96)
|
2.73
(1.28)
|
-1.22
(1.90)
|
6.14
(5.90)
|
Title | Change in Sexual Activity, Interest, and Desire Scale (SAID) |
---|---|
Description | 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. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 12 |
Mean (Standard Error) [units on a scale] |
-0.67
(2.36)
|
4.25
(2.85)
|
-3.00
(3.27)
|
-1.50
(4.67)
|
Title | Change in Derogatis Index of Sexual Function Male II (DISF-M-II) |
---|---|
Description | 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. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 23 | 36 | 12 |
Sexual Desire |
-0.88
(0.89)
|
0.87
(1.63)
|
-0.81
(0.97)
|
1.08
(2.21)
|
Sexual Arousal |
0.45
(0.62)
|
0.83
(0.74)
|
0.00
(0.74)
|
0.67
(0.94)
|
Sexual Activity |
-0.33
(0.65)
|
0.96
(0.81)
|
0.53
(0.67)
|
0.67
(0.83)
|
Orgasm |
0.55
(0.82)
|
0.57
(0.84)
|
-0.31
(0.77)
|
0.75
(2.07)
|
Sexual Satisfaction |
0.27
(0.69)
|
1.22
(1.18)
|
0.22
(0.91)
|
1.42
(1.69)
|
Composite DISF-M-II |
0.06
(2.70)
|
4.43
(3.91)
|
-0.36
(3.26)
|
4.58
(5.98)
|
Title | Change in Three Domains of Men's Sexual Health Questionnaire (MSHQ) |
---|---|
Description | 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. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Erection |
0.80
(0.36)
|
0.80
(0.52)
|
-0.65
(0.48)
|
1.30
(0.45)
|
Ejaculation |
1.34
(1.15)
|
2.38
(1.72)
|
-1.46
(1.16)
|
-1.55
(3.26)
|
Satisfaction |
1.03
(0.58)
|
0.98
(0.85)
|
-0.40
(0.84)
|
1.27
(1.05)
|
Title | Change in Two Domains of Expanded Prostate Cancer Index Composite (EPIC) |
---|---|
Description | 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. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Sexual function |
1.86
(2.14)
|
3.68
(3.04)
|
0.08
(2.52)
|
5.77
(3.90)
|
Hormonal function |
1.24
(1.06)
|
0.44
(2.04)
|
0.52
(1.22)
|
6.25
(5.79)
|
Title | Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale |
---|---|
Description | 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. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Mean (Standard Error) [units on a scale] |
0.31
(1.30)
|
2.29
(1.36)
|
-0.36
(1.28)
|
0.26
(1.47)
|
Title | Change in Hypogonadism Energy Diary (HED) |
---|---|
Description | 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. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Mean (Standard Error) [units on a scale] |
-0.45
(2.78)
|
2.71
(2.82)
|
2.64
(3.42)
|
1.73
(5.07)
|
Title | Change in International Prostate Symptom Score (IPSS) |
---|---|
Description | 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. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Urinary Symptoms |
-0.30
(0.59)
|
-2.08
(0.65)
|
0.06
(0.48)
|
0.00
(0.62)
|
Quality of Life Due to Urinary Symptoms |
-0.13
(0.13)
|
-0.17
(0.17)
|
-0.03
(0.18)
|
-0.15
(0.19)
|
Title | Change in Positive and Negative Affect Scale (PANAS) |
---|---|
Description | 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. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Positive Affect |
0.91
(0.89)
|
0.75
(1.84)
|
1.42
(1.03)
|
-0.77
(0.89)
|
Negative Affect |
-1.70
(0.72)
|
-1.38
(0.58)
|
0.42
(0.58)
|
-2.77
(1.49)
|
Title | Change in Body Mass Using DXA |
---|---|
Description | 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. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 32 | 24 | 34 | 13 |
Appendicular Fat Mass |
-0.06
(0.11)
|
-0.19
(0.10)
|
-0.36
(0.11)
|
-0.13
(0.11)
|
Trunk Fat Mass |
-0.00
(0.14)
|
-0.32
(0.18)
|
-0.38
(0.16)
|
-0.72
(0.19)
|
Total Fat Mass |
-0.05
(0.22)
|
-0.52
(0.24)
|
-0.75
(0.22)
|
-0.86
(0.27)
|
Appendicular Lean Mass |
-0.04
(0.10)
|
0.15
(0.13)
|
0.80
(0.13)
|
1.05
(0.23)
|
Trunk Lean Mass |
0.22
(0.12)
|
0.20
(0.19)
|
0.68
(0.19)
|
0.88
(0.26)
|
Total Lean Mass |
0.20
(0.16)
|
0.33
(0.27)
|
1.48
(0.28)
|
1.92
(0.42)
|
Title | Change of Maximal Voluntary Muscle Strength |
---|---|
Description | The maximal voluntary muscle strength was measured in the leg press exercise using the 1-repetition method |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 17 | 10 | 18 | 7 |
Mean (Standard Error) [N] |
-12.6
(55.0)
|
108.1
(56.8)
|
48.1
(29.4)
|
103.5
(37.1)
|
Title | Change in Gait Speed in 6-minute Walk |
---|---|
Description | Tests of Physical Function and Task-Specific Performance measured by gait speed in 6-min walk |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 28 | 20 | 31 | 10 |
Mean (Standard Error) [m/sec] |
0.05
(0.02)
|
0.07
(0.02)
|
0.08
(0.02)
|
0.05
(0.03)
|
Title | Change of 50 Meters Walk Tests- Unloaded /Loaded |
---|---|
Description | 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. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 28 | 21 | 32 | 11 |
Unloaded |
0.06
(0.03)
|
0.12
(0.04)
|
0.03
(0.02)
|
0.07
(0.06)
|
Loaded |
0.05
(0.03)
|
0.13
(0.05)
|
0.05
(0.04)
|
0.09
(0.05)
|
Title | Change in Power of Stair Climbing Tests- Unloaded/Loaded |
---|---|
Description | 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. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 28 | 21 | 32 | 11 |
Unloaded |
12.8
(26.1)
|
19.7
(19.6)
|
1.8
(15.6)
|
51.7
(21.9)
|
Loaded |
0.22
(24.89)
|
-36.6
(24.9)
|
-9.8
(21.5)
|
59.4
(42.3)
|
Title | Change in Serum Total Testosterone Level |
---|---|
Description | 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. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Mean (Standard Error) [ng/dL] |
-6.5
(15.8)
|
-83.5
(21.3)
|
-172.3
(27.6)
|
-185.2
(46.0)
|
Title | Change in Free Testosterone Level |
---|---|
Description | Free testosterone level for screening was measured using an equilibrium dialysis method. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 32 | 22 | 35 | 13 |
Mean (Standard Error) [pg/mL] |
0.19
(0.15)
|
0.59
(0.18)
|
1.43
(0.20)
|
1.62
(0.41)
|
Title | Change in Serum Sex Hormone-binding Globulin (SHBG) Level |
---|---|
Description | 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 |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 30 | 21 | 35 | 13 |
Mean (Standard Error) [nmol/L] |
0.6
(1.0)
|
-9.6
(1.3)
|
-21.7
(2.1)
|
-24.2
(5.5)
|
Title | Change in Serum Luteinizing Hormone (LH) Level |
---|---|
Description | 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 |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 32 | 22 | 35 | 13 |
Mean (Standard Error) [mIU/mL] |
0.23
(0.27)
|
0.11
(0.23)
|
0.72
(1.27)
|
-0.42
(0.47)
|
Title | Change in Estradiol Levels |
---|---|
Description | Estradiol level was measured by LC-MS/MS. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 32 | 22 | 35 | 13 |
Mean (Standard Error) [pg/mL] |
-0.2
(1.5)
|
-1.1
(1.1)
|
-5.5
(1.1)
|
-7.9
(2.1)
|
Title | Change of White Blood Cell |
---|---|
Description | White Blood Cell was measured for safety monitoring. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Mean (Standard Error) [K/uL] |
-0.24
(0.15)
|
0.30
(0.29)
|
-0.21
(0.19)
|
0.32
(0.20)
|
Title | Change of Red Blood Cell |
---|---|
Description | Red Blood Cell was measured for safety monitoring. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Mean (Standard Error) [K/uL] |
-0.08
(0.04)
|
-0.05
(0.05)
|
0.03
(0.03)
|
0.06
(0.08)
|
Title | Change in Hematocrit |
---|---|
Description | Hematocrit was measured for safety monitoring. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Mean (Standard Error) [percentage of volume of red cells] |
-0.61
(0.33)
|
-0.30
(0.51)
|
0.44
(0.25)
|
0.11
(0.89)
|
Title | Change in Hemoglobin |
---|---|
Description | Hemoglobin was measured for safety monitoring. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Mean (Standard Error) [g/dL] |
-0.32
(0.11)
|
-0.12
(0.16)
|
0.09
(0.09)
|
-0.01
(0.25)
|
Title | Change of Mean Corpuscular Volume (MCV) |
---|---|
Description | Mean corpuscular volume was measured for safety monitoring. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Mean (Standard Error) [fL] |
0.32
(0.30)
|
0.44
(0.48)
|
0.37
(0.31)
|
-1.08
(0.84)
|
Title | Change of Red Blood Cell Distribution Width (RDW) |
---|---|
Description | 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 |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Mean (Standard Error) [percentage of variation of red cells] |
0.09
(0.14)
|
-0.15
(0.22)
|
0.18
(0.10)
|
-0.44
(0.29)
|
Title | Change in Platelet Count |
---|---|
Description | Platelet count was measured for safety monitoring. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Mean (Standard Error) [K/uL] |
0.67
(4.61)
|
6.54
(5.13)
|
13.5
(4.9)
|
28.7
(4.1)
|
Title | Change of Aspartate Aminotransferase (AST) |
---|---|
Description | Aspartate aminotransferase was measured for safety monitoring. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Mean (Standard Error) [U/L] |
-1.24
(0.67)
|
-1.25
(0.81)
|
2.33
(0.82)
|
4.46
(2.03)
|
Title | Change of Alanine Aminotransferase (ALT) |
---|---|
Description | Alanine aminotransferase was measured for safety monitoring. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Mean (Standard Error) [U/L] |
-1.36
(0.89)
|
-3.46
(1.51)
|
1.28
(1.37)
|
5.46
(3.35)
|
Title | Change of Total Bilirubin |
---|---|
Description | Total Bilirubin was measured for safety monitoring. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Mean (Standard Error) [mg/dL] |
-0.13
(0.03)
|
-0.02
(0.03)
|
-0.16
(0.05)
|
-0.18
(0.04)
|
Title | Change in Serum Alkaline Phosphatase |
---|---|
Description | Serum alkaline phosphatase was measured for safety monitoring. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Mean (Standard Error) [U/L] |
-2.94
(1.45)
|
-2.83
(1.55)
|
-8.97
(1.44)
|
-14.1
(3.2)
|
Title | Change of Lipid Panel |
---|---|
Description | Plasma lipids were measured for safety monitoring. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 35 | 13 |
Total Cholesterol |
-7.55
(2.53)
|
-15.1
(5.8)
|
-13.4
(4.5)
|
-14.9
(7.9)
|
HDL |
-2.55
(1.18)
|
-4.38
(1.21)
|
-12.6
(1.3)
|
-14.6
(3.0)
|
LDL |
-6.00
(2.10)
|
-7.13
(5.44)
|
0.57
(4.05)
|
3.92
(6.94)
|
Triglycerides |
9.36
(8.66)
|
-23.5
(7.4)
|
-7.40
(4.57)
|
-31.7
(24.5)
|
Title | Change in Fasting Glucose Levels |
---|---|
Description | Glucose will be measured in a fasting serum sample at Quest Lab. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 33 | 24 | 36 | 13 |
Mean (Standard Error) [mg/dL] |
0.33
(1.74)
|
0.04
(2.02)
|
-2.78
(1.44)
|
-8.54
(4.31)
|
Title | Change in Insulin |
---|---|
Description | Insulin will be measured using an immunoassay at Quest lab. |
Time Frame | 12 weeks from baseline |
Outcome Measure Data
Analysis Population Description |
---|
All randomized and treated participants with data available at the given time-point. |
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 |
---|---|---|---|---|
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. |
Measure Participants | 15 | 11 | 16 | 3 |
Mean (Standard Error) [uIU/mL] |
-0.17
(0.93)
|
0.36
(1.52)
|
-1.63
(0.68)
|
-1.00
(0.50)
|
Adverse Events
Time Frame | 12 weeks | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||
Arm/Group Title | Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 | ||||
Arm/Group Description | Placebo: The participants will receive pills containing no active drug daily for 12-weeks. | 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. | 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. | 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. | ||||
All Cause Mortality |
||||||||
Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Serious Adverse Events |
||||||||
Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/36 (5.6%) | 2/28 (7.1%) | 1/36 (2.8%) | 1/14 (7.1%) | ||||
Cardiac disorders | ||||||||
Myocardial infarction | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Musculoskeletal and connective tissue disorders | ||||||||
Pain in extremity | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Pain in extremity | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
Metastatic ocular melanoma | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Renal and urinary disorders | ||||||||
Renal Cancer | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Surgical and medical procedures | ||||||||
Coronary artery bypass | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
Placebo | LY2452473 Dose 1 | LY2452473 Dose 2 | LY2452473 Dose 3 | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 33/36 (91.7%) | 22/28 (78.6%) | 33/36 (91.7%) | 10/14 (71.4%) | ||||
Blood and lymphatic system disorders | ||||||||
Lymphadenopathy | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Cardiac disorders | ||||||||
Angina pectoris | 0/36 (0%) | 2/28 (7.1%) | 4 | 0/36 (0%) | 4 | 0/14 (0%) | 4 | |
Atrial fibrillation | 1/36 (2.8%) | 2 | 0/28 (0%) | 2 | 0/36 (0%) | 2 | 0/14 (0%) | 2 |
Chest discomfort | 0/36 (0%) | 1/28 (3.6%) | 2 | 0/36 (0%) | 2 | 0/14 (0%) | 2 | |
Dizziness | 1/36 (2.8%) | 3 | 0/28 (0%) | 3 | 0/36 (0%) | 3 | 0/14 (0%) | 3 |
Palpitations | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Tachycardia | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Ventricular arrhythmia | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Ventricular tachycardia | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Endocrine disorders | ||||||||
Diabetes mellitus | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Goitre | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Eye disorders | ||||||||
Asthenopia | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Cataract | 2/36 (5.6%) | 3 | 1/28 (3.6%) | 3 | 0/36 (0%) | 3 | 0/14 (0%) | 3 |
Diplopia | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Dry eye | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Eye haemorrhage | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Iritis | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Lacrimation increased | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Ocular hyperaemia | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Vision blurred | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Gastrointestinal disorders | ||||||||
Abdominal discomfort | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Abdominal distension | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Abdominal pain | 1/36 (2.8%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Constipation | 1/36 (2.8%) | 1/28 (3.6%) | 2/36 (5.6%) | 0/14 (0%) | ||||
Diarrhoea | 3/36 (8.3%) | 1/28 (3.6%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Diverticulitis | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Dyspepsia | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Dysphagia | 1/36 (2.8%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Faeces discoloured | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Flatulence | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Gastroesophageal reflux disease | 1/36 (2.8%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Glossodynia | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Hiatus hernia | 0/36 (0%) | 0/28 (0%) | 2/36 (5.6%) | 0/14 (0%) | ||||
Inguinal hernia | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Nausea | 4/36 (11.1%) | 5 | 1/28 (3.6%) | 5 | 1/36 (2.8%) | 5 | 0/14 (0%) | 5 |
Oesophageal food impaction | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Oral pain | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Swollen tongue | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Toothache | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Vomiting | 2/36 (5.6%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
General disorders | ||||||||
Decreased appetite | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Fatigue | 5/36 (13.9%) | 1/28 (3.6%) | 2/36 (5.6%) | 1/14 (7.1%) | ||||
Increased appetite | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Influenza like illness | 1/36 (2.8%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Night sweats | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Non-cardiac chest pain | 1/36 (2.8%) | 1/28 (3.6%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Pain | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Pyrexia | 1/36 (2.8%) | 2/28 (7.1%) | 0/36 (0%) | 0/14 (0%) | ||||
Immune system disorders | ||||||||
Hypersensitivity | 1/36 (2.8%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Infections and infestations | ||||||||
Bronchitis | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Lyme Disease | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Nasopharyngitis | 1/36 (2.8%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Norovirus infection | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Pharyngitis streptococcal | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Pneumonia | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Sinusitis | 2/36 (5.6%) | 0/28 (0%) | 2/36 (5.6%) | 3 | 1/14 (7.1%) | 3 | ||
Skin infection | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Tooth infection | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Upper respiratory tract infection | 3/36 (8.3%) | 0/28 (0%) | 2/36 (5.6%) | 0/14 (0%) | ||||
Injury, poisoning and procedural complications | ||||||||
Animal bite | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Arthropod bite | 2/36 (5.6%) | 2/28 (7.1%) | 2/36 (5.6%) | 0/14 (0%) | ||||
Contusion | 2/36 (5.6%) | 3 | 0/28 (0%) | 3 | 1/36 (2.8%) | 3 | 3/14 (21.4%) | 11 |
Face injury | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Fall | 0/36 (0%) | 1/28 (3.6%) | 3 | 0/36 (0%) | 3 | 0/14 (0%) | 3 | |
Hand injury | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Ligament sprain | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Palate injury | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Post procedural complication | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Skin abrasion | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 1/14 (7.1%) | 2 | |||
Sunburn | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Thermal burn | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 3 | 0/14 (0%) | 3 | ||
Wound | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Investigations | ||||||||
Alanine aminotransferase increased | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Biopsy skin | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Blood cholesterol increased | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Blood iron decreased | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Breath sounds abnormal | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Electrocardiogram ST segment depression | 0/36 (0%) | 1/28 (3.6%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Metabolism and nutrition disorders | ||||||||
Hyperglycaemia | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Hypertriglyceridemia | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Musculoskeletal and connective tissue disorders | ||||||||
Ankle impingement | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Arthralgia | 1/36 (2.8%) | 2/28 (7.1%) | 3/36 (8.3%) | 0/14 (0%) | ||||
Arthritis | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Back pain | 2/36 (5.6%) | 5/28 (17.9%) | 2/36 (5.6%) | 3 | 2/14 (14.3%) | 3 | ||
Joint effusion | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Ligament sprain | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Muscle spasms | 1/36 (2.8%) | 2 | 1/28 (3.6%) | 2 | 1/36 (2.8%) | 2 | 1/14 (7.1%) | 2 |
Muscle strain | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Muscular weakness | 0/36 (0%) | 2/28 (7.1%) | 2/36 (5.6%) | 0/14 (0%) | ||||
Myalgia | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 1/14 (7.1%) | 2 | |||
Neck pain | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Pain in extremity | 2/36 (5.6%) | 3 | 0/28 (0%) | 3 | 5/36 (13.9%) | 8 | 2/14 (14.3%) | 8 |
Plantar fasciitis | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Sciatica | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Tendonitis | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
Cancer fatigue | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Cyst | 1/36 (2.8%) | 3 | 0/28 (0%) | 3 | 1/36 (2.8%) | 2 | 0/14 (0%) | 2 |
Renal cyst | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Thyroid cyst | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Nervous system disorders | ||||||||
Cognitive disorder | 2/36 (5.6%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Headache | 2/36 (5.6%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Migraine | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Paraesthesia | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Presyncope | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Syncope | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Taste disorder | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Psychiatric disorders | ||||||||
Anxiety | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Depression | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 1/14 (7.1%) | ||||
Renal and urinary disorders | ||||||||
Chromaturia | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Haematuria | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Micturition disorder | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Polyuria | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Urinary incontinence | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Reproductive system and breast disorders | ||||||||
Scrotal pain | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Testicular pain | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Respiratory, thoracic and mediastinal disorders | ||||||||
Cough | 3/36 (8.3%) | 4/28 (14.3%) | 4/36 (11.1%) | 1/14 (7.1%) | ||||
Dyspnoea | 1/36 (2.8%) | 2/28 (7.1%) | 1/36 (2.8%) | 1/14 (7.1%) | ||||
Nasal congestion | 3/36 (8.3%) | 5/28 (17.9%) | 0/36 (0%) | 2/14 (14.3%) | ||||
Obstructive airways disorder | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Oropharyngeal pain | 0/36 (0%) | 2/28 (7.1%) | 5/36 (13.9%) | 0/14 (0%) | ||||
Rhinitis allergic | 0/36 (0%) | 0/28 (0%) | 0/36 (0%) | 2/14 (14.3%) | ||||
Sinus pain | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Skin and subcutaneous tissue disorders | ||||||||
Abdominal pain | 0/36 (0%) | 1/28 (3.6%) | 0/36 (0%) | 0/14 (0%) | ||||
Actinic keratosis | 0/36 (0%) | 1/28 (3.6%) | 2 | 1/36 (2.8%) | 2 | 0/14 (0%) | 2 | |
Alopecia | 0/36 (0%) | 0/28 (0%) | 2/36 (5.6%) | 0/14 (0%) | ||||
Basal cell carcinoma | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 2 | 0/14 (0%) | 2 | ||
Dermatitis contact | 0/36 (0%) | 1/28 (3.6%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Dry skin | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | ||||
Pain of skin | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Pruritus | 0/36 (0%) | 1/28 (3.6%) | 2/36 (5.6%) | 0/14 (0%) | ||||
Psoriasis | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Rash | 2/36 (5.6%) | 0/28 (0%) | 0/36 (0%) | 1/14 (7.1%) | 2 | |||
Rash maculo-papular | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Rosacea | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Skin abrasion | 0/36 (0%) | 2/28 (7.1%) | 0/36 (0%) | 0/14 (0%) | ||||
Skin induration | 1/36 (2.8%) | 0/28 (0%) | 0/36 (0%) | 0/14 (0%) | ||||
Skin laceration | 2/36 (5.6%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Skin mass | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Urticaria | 0/36 (0%) | 0/28 (0%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Surgical and medical procedures | ||||||||
Cataract operation | 1/36 (2.8%) | 2 | 0/28 (0%) | 2 | 0/36 (0%) | 2 | 0/14 (0%) | 2 |
Vascular disorders | ||||||||
Haematoma | 0/36 (0%) | 2/28 (7.1%) | 1/36 (2.8%) | 0/14 (0%) | ||||
Hypertension | 0/36 (0%) | 1/28 (3.6%) | 3/36 (8.3%) | 1/14 (7.1%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Shalender Bhasin, Principal Investigator |
---|---|
Organization | Brigham and Women's hospital |
Phone | 617 525 9150 |
sbhasin@bwh.harvard.edu |
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