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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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
Phase 3 N=790 The Testosterone Trials in Older Men
Andropause
Primary: Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12 — 1.4; 1.4; 0.6; 0.1 units on the PDQ-Q4 scale — p=<0.001
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=137 Testosterone Replacement in Men With Diabetes and Obesity
Hypogonadism
Primary: Insulin Sensitivity — 6.66; 5.12; 11.37; 12.93 mg/kg fat free mass/min
Phase 2 N=34 Oral Testosterone for the Treatment of Hypogonadism
Hypogonadism
Primary: Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With…
Phase 4 N=140 Effect of Testosterone in Men With Erectile Dysfunction
Erectile Dysfunction · Testosterone Deficiency · Diabetes
Primary: Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF) — 19.6; 20.1; 21.3; 21.3 units on a scale
Phase 3 N=31 Testosterone Replacement Therapy in Chronic Spinal Cord Injury
Spinal Cord Injury · Hypogonadism
Primary: Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM) — 53.1; 50.5 kilograms — p=<0.01
Phase 4 N=92 Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism
Type 2 Diabetes Mellitus · Hypogonadism
Primary: Finite Element Analysis of Bone to Measure Bone Strength — 1.2; 1.6; 1.6; 0.88 % change — p=<0.05
N/A N=17 Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
Kidney Failure · Kidney Diseases
Primary: Thigh Cross Sectional Area — 58.2 centimeters squared
Phase 3 N=25 Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Physical Frailty · Hip Fracture · Elective Hip Replacement
Primary: Mean Change in Total Lean Body Mass — 0.5; 2.3 kg — p=0.01
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
Phase 2 N=35 Testosterone and Growth Hormone for Bone Loss in Men
Hypopituitarism · Hypogonadism · Growth Hormone Deficiency
Primary: MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment. — 0.112; 0.104; 0.119; 0.111 unitless
Phase 3 N=149 A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone
Hypogonadism
Primary: Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90 — 77.5 percentage of participants
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
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 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=76 A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels
Ejaculatory Dysfunction · Hypogonadism
Primary: Change From Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks — 3.61; 2.95 units…
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 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=150 Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism
Hypogonadism
Primary: Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL) — 139 Participants
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
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
Phase 4 N=5,204 A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men
Hypogonadism · Cardiovascular Diseases
Primary: Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event — 182; 190 Participants
Phase 1 N=105 CYP19A1 (Cytochrome P450 Family 19 Subfamily A Member 1) Gene and Pharmacogenetics of Response to Testosterone Therapy
Hypogonadism
Primary: Percent Change in Bone Mineral Density (BMD) According to rs700518 Polymorphism in the CYP19A1 Gene — 3.69; 4.13; 3.82; 0.38 percent change — p=<0.05
Phase 4 N=20 Testosterone Gel Applied to Women With Pituitary Gland Problems
Panhypopituitarism
Primary: Fatigue Impact Scale — -22.9; 2.2 units on a scale — p=0.08
Phase 3 N=321 Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Male Hypogonadism
Primary: Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL — 83.6; 79.2 percentage of partipants
Phase 2 N=60 5-Alpha Reductase and Anabolic Effects of Testosterone
Male Hypogonadism · Muscle Atrophy · Sarcopenia
Primary: 1 Repetition Maximum (1-RM) Strength Testing — 129.1; 109.4; 137.2; 118.8 kg — p=<0.001
Phase 3 N=715 A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy
Hypogonadism
Primary: Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12 — 43; 217 participants — p=<0.001
Phase 3 N=144 Safety and Efficacy Trial of Testosterone Undecanoate
Male Hypogonadism
Primary: Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL — 87 Participants