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
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N/A N=10 HOP-2A - Intratesticular Hormone Levels
Healthy · Male Infertility · Prostate Disease
Primary: Intratesticular Hormones in Normal Men — 486; 3.0; 3.7; 0.20 ng/mL
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=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 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 3 N=222 A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Hypogonadism
Primary: Number of Oral TU Treated Subjects Who Have a Total T Cavg in the Eugonadal Range of 252 to 907 ng/dL at Visit 7 — 145; 48 Participants
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 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 3 N=306 Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
Male Hypogonadism
Primary: Serum Testosterone Cavg — 76; 43; 61 Participants
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 4 N=246 A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
Hypogonadism
Primary: Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP) — 1.9 mmHg
Phase 1 N=9 Opioid Antagonism in Hypogonadotropic Hypogonadism
Hypogonadotropic Hypogonadism · Low Testosterone
Primary: Average Change in Mean Luteinizing Hormone (LH) Value — 1.571 IU/L
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=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=18 A Study of the Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adult Men With Hypogonadotropic Hypogonadism (HH) (P07937)
Hypogonadism · Hypogonadotropic Hypogonadism
Primary: Change From Baseline in Log-Transformed Testicular Volume at Week 52 — 2.3 Fold change
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=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
Phase 3 N=314 Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men
Hypogonadism, Male
Primary: Percentage of Male Hypogonadal Subjects With Average NaF/EDTA Plasma Total Testosterone (T Cavg) Within the Normal Range Using Oral SOV2012-F1. — 166 Participants
Phase 3 N=133 Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
Hypogonadism
Primary: Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism…
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 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 2 N=17 To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
Secondary Hypogonadism
Primary: Sperm Concentration — 0.54; 72.8; 3.00; 182.6 millions sperm/mL — p=0.118
Phase 2 N=271 Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
Hypogonadotropic Hypogonadism
Primary: Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment — 59; 62; 63; 7 Participants
Phase 2 N=14 Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]
Puberty, Precocious
Primary: Change in Growth Rate (cm/Year) — -1.62 cm/year — p=0.278
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 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 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 1 N=40 Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men
Hypogonadism
Primary: Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours — 463 ng/dL
Phase 2 N=50 A Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene
Acquired Hypogonadotropic Hypogonadism · Obesity
Primary: Change From Baseline in Lean Body Mass (LBM) at Week 48 — 65.23; 65.60; 68.12; 3.14 kg — p=0.7103