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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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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=39 LutrePulse Hypogonadotropic Hypogonadism
Primary Amenorrhea With Hypogonadotropic Hypogonadism
Primary: Ovulation Rate — 1; 4; 5; 9 Participants — p=0.0120
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=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=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 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 2 N=14 Effect of Intranasal Insulin on LH Concentrations in Man
Hypogonadotropic Hypogonadism
Primary: LH — 7.7; 3.3; 7.9; 3.8 IU/L
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 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
N/A N=62 Reproductive Hormonal Alterations in Obesity
Obesity
Primary: Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1) — 4.1; 3.6 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 4 N=20 Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia
Growth Hormone Deficiency · Septo-Optic Dysplasia · Hypopituitarism
Primary: Change in Anthropometric Measures Over Time — 1.97; -0.61; 1.39; 1.22 Z-score
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
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=88 Anastrozole Administration in Elderly Hypogonadal Men
Hypogonadism
Primary: Change in Lean Body Mass — -2000; -1500 grams
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 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 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=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=306 Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
Male Hypogonadism
Primary: Serum Testosterone Cavg — 76; 43; 61 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 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 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=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 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 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=31 A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism
Hypogonadism
Primary: Number of Participants Who Met Both Index 1 and Index 2 — 23 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