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
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Phase 3 N=39 LutrePulse Hypogonadotropic Hypogonadism
Primary Amenorrhea With Hypogonadotropic Hypogonadism
Primary: Ovulation Rate — 1; 4; 5; 9 Participants — p=0.0120
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 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=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 3 N=499 Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Secondary Hypogonadism
Primary: Change From Baseline in Total Morning Testosterone at 26 Weeks — 280.9; 214.7 ng/dL
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 3 N=24 Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)
PCOS
Primary: 17OHP Levels After hCG — 3.2; 1.3 ng/ml
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 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
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 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
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…
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 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=17 Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolescent Males With Hypogonadotropic Hypogonadism (HH) (MK-8962-043)
Hypogonadotropic Hypogonadism
Primary: Change From Baseline in Log-Transformed Testicular Volume (TV) to Week 64 — 1.5; 14.5 mL
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=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=13 Clomiphene Citrate for the Treatment of Low Testosterone Associated With Chronic Opioid Pain Medication Administration
Hypogonadism · Opioid-Related Disorders · Male Infertility
Primary: Serum Total Testosterone (Change From Baseline) — 322.5; 179.8 ng/mL
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 3 N=25 Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)
Polycystic Ovary Syndrome
Primary: Serum 17OHP Responses to hCG — 2.0; 1.2; 1.1; 1.0 ng/ml — p=<0.05
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 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=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=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 2 N=59 GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients
Amenorrhea · Premature Ovarian Failure · Ovarian Function Insufficiency
Primary: Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide — 37 participants
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=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 4 N=15 Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Growth Hormone Deficiency · Traumatic Brain Injury
Primary: Maximum Oxygen Uptake at Baseline. — 29.0 mL/kg/min
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