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 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
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=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 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 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=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=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=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 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 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=24 Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)
PCOS
Primary: 17OHP Levels After hCG — 3.2; 1.3 ng/ml
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
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=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=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=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=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 4 N=40 Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder
Hypoactive Sexual Desire Disorder
Primary: Changes in Blood Oxygen Level Dependent (BOLD) Signal Change on Functional MRI — 9.98; 7.67 BOLD signal change
N/A N=30 Estrogen Sensitivity and Ovulatory Dysfunction in Obesity
Obesity · Infertility
Primary: Luteinizing Hormone Pulse Amplitude — 2.73; 1.12 IU/L
Phase 2 N=143 A 6 Month Safety Extension Study of MBGS205
Hypogonadotropic Hypogonadism
Primary: Percent Change in Bone Mineral Density Measured by DEXA (g/cm^2) From Baseline in Study MBGS205 to Week 48 in Study MBGS206 — -2.24; -3.31; -1.68 Percentage change
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…
N/A N=60 Dysregulation of FSH in Obesity: Functional and Statistical Analysis
Obesity · Fertility
Primary: Difference Between Peak Inhibin B — 100.8; 38.8 picograms/mL
Phase 2 N=20 Study of Leptin for the Treatment of Hypothalamic Amenorrhea
Amenorrhea
Primary: the Difference Between the Placebo and Leptin Treated Groups in the Change in Bone Mineral Content(BMC) at the Anteroposterior (AP) Spine From Baseline to 36 Weeks…
Phase 2 N=57 Efficacy and Tolerability of an Intra-Nasal Testosterone Product
Hypogonadism
Primary: Serum Testosterone Ln-Cmax — 6.25; 6.41; 6.54; 6.36 ng/dL
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=105 Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles
Infertility
Primary: Total Fertilization Proportion (i.e. Total Competent Proportion) — 0.59; 0.65 ratio
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