Phase 2 N=35 Maximal Suppression of the Androgen Axis in Clinically Localized Prostate Cancer
Cancer · Prostate Neoplasms
Primary: Prostate Tissue DHT — 0.03; 0.06; 0.03 ng/g
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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
N/A N=16 A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men With Castration Resistant Prostate Cancer
Prostate Cancer
Primary: Percentage of Patients Completing at Least 3 Months of Therapy With a PSA Below Baseline. — 42.9 Percentage of Participants
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 2 N=53 A Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer
Prostate Cancer
Primary: Testosterone Levels — 1.02; 1.05 ng/dL — p=0.4879
Phase 4 N=78 The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel
Hypogonadism
Primary: Percentage of Participants Achieving Normal Serum Testosterone Levels — 94.7 percentage of participants
Phase 2 N=20 Efficacy, Pharmacokinetics and Safety of Testosterone
Testicular Hypogonadism
Primary: Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were…
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=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 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=8 Phlebotomy Study of Testosterone Undecanoate
Hypogonadism
Primary: % of Mean Difference in T Concentration Compared to Plain Collection Tube — 8.6; 16.6; 23.2 Difference as % of Mean of T results
Phase 4 N=60 Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters
Hypogonadism, Male
Primary: Change in Testosterone Levels From Baseline to 27 Weeks — 652 ng/dL
Phase 2 N=40 HOP-3 Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone
Healthy Males
Primary: Serum Testosterone (T) — 0.43; 1.5; 3.7; 8.4 nmol/liter — p=<0.05
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 3 N=180 A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel
Adult Male Hypogonadism
Primary: The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL — 2.9; 4.7; 77.9; 85.5 percentage of participants
Phase 3 N=155 A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations
Hypogonadism
Primary: Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120 — 84.1 percentage of participants — p=<0.001
Phase 3 N=163 Efficacy and Safety of Leuprolide Acetate 22.5 mg Depot in Treatment of Prostate Cancer
Prostate Cancer
Primary: Percentage of Participants Achieving Chemical Castration (Defined as Testosterone Levels ≤ 0.5 ng/mL) at Days 28, 84, and 168. — 98.1 percentage of participants
Phase 2 N=40 ITT4 Intratesticular Hormonal Milieu in Man (ITT4)
Healthy Males
Primary: Intratesticular Testosterone (IT-T) Level — 14; 3.7; 1.7; 18.4 ng/mL — p=<0.05
N/A N=60 De-implementation of Low Value Castration for Men With Prostate Cancer
Cancer of Prostate
Primary: Feasibility - Site Level: Medical Center Director (MCD) Approval — 3; 1 sites
Phase 2 N=36 Testosterone and Olaparib in Treating Patients With Castration-Resistant Prostate Cancer
Castration-Resistant Prostate Carcinoma · Prostate Adenocarcinoma
Primary: Percent of Patients With a Prostate-specific Antigen (PSA) Decline of at Least 50% Below Baseline PSA50 Response Rate — 14 Participants
Phase 2 N=84 Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception
Pain · Hypogonadism
Primary: Brief Pain Inventory (BPI) at Week 14 — 10.2; 9.7; 5.3; 5.1 units on a scale
Phase 3 N=62 PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate
Healthy
Primary: Prostate Tissue DHT Concentrations After Treatment — 4.05; 4.26; 2.99; 3.88 ng/g
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=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
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=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=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 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 2 N=41 Castration Compared to Castration Plus Metformin as First Line Treatment for Patients With Advanced Prostate Cancer
Prostate Cancer
Primary: Metabolic Syndrome — 0; 0 kilograms