A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02499497
Collaborator
National Institute of Nursing Research (NINR) (NIH)
114
4
4
56
28.5
0.5

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

Study Type:
Interventional
Actual Enrollment :
114 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
Actual Study Start Date :
Feb 29, 2016
Actual Primary Completion Date :
Oct 31, 2020
Actual Study Completion Date :
Oct 31, 2020

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:
  • Inactive comparator
  • 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:
  • Selective Androgen Receptor Modulator
  • 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:
  • Selective Androgen Receptor Modulator
  • 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:
  • Selective Androgen Receptor Modulator
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    9. 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.

    10. 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.

    11. 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

    12. 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

    13. 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.

    14. 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.

    15. 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.

    16. Change in Free Testosterone Level [12 weeks from baseline]

      Free testosterone level for screening was measured using an equilibrium dialysis method.

    17. 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

    18. 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

    19. Change in Estradiol Levels [12 weeks from baseline]

      Estradiol level was measured by LC-MS/MS.

    20. Change of White Blood Cell [12 weeks from baseline]

      White Blood Cell was measured for safety monitoring.

    21. Change of Red Blood Cell [12 weeks from baseline]

      Red Blood Cell was measured for safety monitoring.

    22. Change in Hematocrit [12 weeks from baseline]

      Hematocrit was measured for safety monitoring.

    23. Change in Hemoglobin [12 weeks from baseline]

      Hemoglobin was measured for safety monitoring.

    24. Change of Mean Corpuscular Volume (MCV) [12 weeks from baseline]

      Mean corpuscular volume was measured for safety monitoring.

    25. 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

    26. Change in Platelet Count [12 weeks from baseline]

      Platelet count was measured for safety monitoring.

    27. Change of Aspartate Aminotransferase (AST) [12 weeks from baseline]

      Aspartate aminotransferase was measured for safety monitoring.

    28. Change of Alanine Aminotransferase (ALT) [12 weeks from baseline]

      Alanine aminotransferase was measured for safety monitoring.

    29. Change of Total Bilirubin [12 weeks from baseline]

      Total Bilirubin was measured for safety monitoring.

    30. Change in Serum Alkaline Phosphatase [12 weeks from baseline]

      Serum alkaline phosphatase was measured for safety monitoring.

    31. Change of Lipid Panel [12 weeks from baseline]

      Plasma lipids were measured for safety monitoring.

    32. Change in Fasting Glucose Levels [12 weeks from baseline]

      Glucose will be measured in a fasting serum sample at Quest Lab.

    33. Change in Insulin [12 weeks from baseline]

      Insulin will be measured using an immunoassay at Quest lab.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

    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.
    Responsible Party:
    Shalender Bhasin, MD, Principal Investigator, Dana-Farber Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT02499497
    Other Study ID Numbers:
    • 15-120
    First Posted:
    Jul 16, 2015
    Last Update Posted:
    Sep 28, 2021
    Last Verified:
    Sep 1, 2021
    Keywords provided by Shalender Bhasin, MD, Principal Investigator, Dana-Farber Cancer Institute
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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)
    2. Secondary Outcome
    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)
    3. Secondary Outcome
    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)
    4. Secondary Outcome
    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)
    5. Secondary Outcome
    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)
    6. Secondary Outcome
    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)
    7. Secondary Outcome
    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)
    8. Secondary Outcome
    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)
    9. Secondary Outcome
    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)
    10. Secondary Outcome
    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)
    11. Secondary Outcome
    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)
    12. Secondary Outcome
    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)
    13. Secondary Outcome
    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)
    14. Secondary Outcome
    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)
    15. Secondary Outcome
    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)
    16. Secondary Outcome
    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)
    17. Secondary Outcome
    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)
    18. Secondary Outcome
    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)
    19. Secondary Outcome
    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)
    20. Secondary Outcome
    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)
    21. Secondary Outcome
    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)
    22. Secondary Outcome
    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)
    23. Secondary Outcome
    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)
    24. Secondary Outcome
    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)
    25. Secondary Outcome
    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)
    26. Secondary Outcome
    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)
    27. Secondary Outcome
    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)
    28. Secondary Outcome
    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)
    29. Secondary Outcome
    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)
    30. Secondary Outcome
    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)
    31. Secondary Outcome
    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)
    32. Secondary Outcome
    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)
    33. Secondary Outcome
    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)
    34. Secondary Outcome
    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

    [Not Specified]

    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
    Email sbhasin@bwh.harvard.edu
    Responsible Party:
    Shalender Bhasin, MD, Principal Investigator, Dana-Farber Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT02499497
    Other Study ID Numbers:
    • 15-120
    First Posted:
    Jul 16, 2015
    Last Update Posted:
    Sep 28, 2021
    Last Verified:
    Sep 1, 2021