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
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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 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=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 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=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 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=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=76 Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature
Idiopathic Short Stature
Primary: Change in Height — 14; 17.1; 18.9 Centimeters — p=<0.006
Phase 2 N=88 Anastrozole Administration in Elderly Hypogonadal Men
Hypogonadism
Primary: Change in Lean Body Mass — -2000; -1500 grams
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 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
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
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 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 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
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 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 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=101 Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test.
Diagnosis of Adult Growth Hormone Deficiency (AGDH)
Primary: Receiver Operating Characteristic (ROC) Analysis on Peak GH (Growth Hormon) Concentrations — 2.36; 17.71 ng/mL
Phase 2 N=16 Clomiphene Citrate for Treatment of Acromegaly
Acromegaly
Primary: IGF-1 Levels — 424 ng/mL — p=< 0.05
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 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
N/A N=75 Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency
Acromegaly · Growth Hormone Deficiency · Pituitary Disease
Primary: Change in High-sensitivity C-reactive Protein — 2.93; 3.23; -0.36; 1.64 mg/liter
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=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=25 Oral Testosterone for the Treatment of Hypogonadism in Males
Hypogonadism
Primary: Percentage of Responders — 67; 57; 50; 100 percentage of subjects
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=91 Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature
Idiopathic Short Stature (ISS)
Primary: Number of Participants With One or More Drug-related Adverse Events — 42; 38; 11; 9 participants
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