Phase 4 N=100 AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment
Depressive Disorder, Major
Primary: 21-item Hamilton Depression Rating Scale Score (HAM-D) — 13.5; 15.6 units on a scale — p=0.71
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=35 Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial.
Hypogonadism · Diabetes · Sarcopenia
Primary: Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density — 0.042; 0.008; 0.047 g/cm2
Phase 2 N=88 Anastrozole Administration in Elderly Hypogonadal Men
Hypogonadism
Primary: Change in Lean Body Mass — -2000; -1500 grams
N/A N=33 Metabolic Effects of Androgenicity in Aging Men and Women
Aging · Insulin Resistance
Primary: Insulin Sensitivity — -0.16; 2.62; -0.50; 1.83 micro International Units/mL — p=0.023
Phase 2 N=124 Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
Secondary Hypogonadism
Primary: Change in Total Morning Testosterone — -16.9; 253.7; 258.5; 197.3 ng/dL
Phase 4 N=23 Aromatase Inhibitors and Weight Loss in Severely Obese Hypogonadal Male Veterans (Pilot)
Hypogonadism · Severe Obesity
Primary: Percent Change in Muscle Strength as Assessed by Knee Extension and Knee Flexion — 12.6; 8.9; 12.8; 3.7 Percent change in muscle strength
Phase 3 N=43 Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients
Advanced Cancer
Primary: Functional Assessment of Cancer Therapy-Fatigue Subscale (FACIT-F) at Day 29 (+/- 3 Days) — 12; 13; 12; 14 units on a scale
N/A N=25 Androgen Effects in HIV-infected Women
HIV Infection
Primary: Lean Body Mass — 1.8; 0.8 kilograms — p=0.04
Phase 2 N=167 TEAM: Testosterone Supplementation and Exercise in Elderly Men
Healthy
Primary: Physical Function (CS-PFP Total Score) — 3.1; 3.6; 0.8; 3.3 units on a scale — p=<0.025
Phase 4 N=168 A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants
Hypogonadism
Primary: Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16 — 123.2; 3.5 millimeters of mercury (mmHg)
N/A N=22 Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male
Hypogonadism, Male · Physical Activity · Testosterone Deficiency
Primary: Change From Baseline in Lean Mass — 2734; 499; 2268 grams
Phase 3 N=181 Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism
Secondary Hypogonadism
Primary: Subjects With Testosterone in Normal Range After Treatment — 81.3 Percentage of Subjects
Phase 4 N=308 Testosterone Replacement in Older Men and Atherosclerosis Progression
Hypogonadism · Atherosclerosis
Primary: Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT) — 0.877; 0.879; 0.036; 0.033 mm
N/A N=177 Dose-Response of Gonadal Steroids and Bone Turnover in Older Men
Healthy Volunteers
Primary: Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX) — 103; 41; 29; 15 percentage change
Phase 2 N=60 The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
Secondary Hypogonadism
Primary: 24 Hour Average and Maximum Testosterone Concentration — 262.3; 373.6; 298.3; 322.4 ng/dL — p=0.056
Phase 4 N=673 A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
Hypogonadism · Hypogonadism, Male · Hypogonadotropic Hypogonadism
Primary: Change From Baseline in 24-Hour Average Systolic Ambulatory Blood Pressure to End of Study (EOS) — 2.77; 2.78; 2.15 millimeters of mercury (mmHg)
Phase 2 N=10 Testosterone Treatment for Multiple Sclerosis
Multiple Sclerosis
Primary: Whole Brain Atrophy Rate — .82 percent change in brain volume — p=<0.05
Phase 3 N=151 Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism
Secondary Hypogonadism
Primary: Proportion (Percentage) of Androxal Treated Subjects With Testosterone in the Normal Range — 78.8 Percentage of Subjects
Phase 3 N=227 Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment
Arthralgia · Breast Cancer · Hot Flashes
Primary: Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3 — -1.9; -2.0 score on a scale — p=0.4952
N/A N=1,049 ESPRIT Study in Hypogonadal Men
Hypogonadism
Primary: Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score — -29.0 Percent Change
Phase 2 N=15 Testosterone Replacement for Male Opioid Agonist Maintained Patients
Chronic Pain · Opioid Addiction · Symptomatic Hypogonadism
Primary: Number of Participants Demonstrating Abstinence — 5; 4 Participants
Phase 2 N=195 Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance
Castration Resistant Metastatic Prostate Cancer
Primary: Progression Free Survival as Measured by Number of Months Until Clinical or Radiographic Progression — 5.62; 5.72 months
Phase 3 N=274 Testosterone Treatment for Hypogonadal Men
Hypogonadism
Primary: Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day…
Phase 4 N=49 Effect of Androgel on Type 2 Diabetic Males With Hypogonadism
Diabetes Mellitus Type 2
Primary: Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo — 100; 100; 100; 236 Percent change from baseline
Phase 3 N=83 Lifestyle Intervention and Testosterone Replacement in Obese Seniors
Obesity and Hypogonadism
Primary: Change in the Physical Performance Test — 4.6; 4.9 units on a scale — p=0.58
Phase 3 N=22 Hormone and Information Processing Study
Mild Cognitive Impairment · Alzheimer's Disease
Primary: Behavioral & Mood Measure: Profile of Mood States (POMS) — 57.7; 55.5; -4.5; -0.1 units on a scale
N/A N=25 Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer
Bladder Cancer · Low Testosterone Levels
Primary: Number of Hypogonadism in Participants Based on Serum Testosterone 90 Days Post Radical — 6 participants
Phase 2 N=25 Oral Testosterone for the Treatment of Hypogonadism in Males
Hypogonadism
Primary: Percentage of Responders — 67; 57; 50; 100 percentage of subjects
Phase 2 N=24 Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function
Hypogonadism, Male
Primary: IIEF (International Index of Erectile Function) Score - Screen — 34; 43; 57; 41 score on a scale
Phase 4 N=24 Testosterone for Peripheral Vascular Disease
Hypogonadism · Peripheral Vascular Disease · Type 2 Diabetes
Primary: Change in Arterial Stiffness — 15.02; 15.08; 14.08; 16.12 index β