Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal...
HypogonadismMaleThis is an open-label, multi-center, single arm study evaluating the blood pressure (BP) changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood pressure monitoring (ABPM) in LPCN 1021 treated adult hypogonadal male subjects.
Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate...
HypogonadismPrimary Hypogonadism1 moreTo evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.
Estrogen Treatment (Oral vs. Patches) in Turner Syndrome
Turner SyndromeHypogonadism1 moreThe study attempts to evaluate if the way of administering estrogen, the principal female hormone, via patches or orally, affects the way estrogen works in girls with Turner Syndrome. These are girls who are very short and whose ovaries do not work. We will examine changes bone, protein and fat metabolism under the influence of estrogen delivered by a patch trough the skin vs estrogen taken orally. These studies are conducted while the girls are taking GH therapy.
Patient and Healthcare Professional Views on Genetic/Genomic Information and Testing
HypogonadismHypogonadotropic1 moreTechnologic advances (i.e. next generation sequencing technologies and novel bioinformatics approaches) have been drivers of scientific discovery and have deepened our understanding of the genetics and genomics of health and disease. In parallel, the falling cost of sequencing has led to screening moving from specialty clinics into the primary care setting. However, our ability to help patients and families understand these technologies and related genetic health literacy issues lag behind. These factors pose a number of questions and challenges for clinicians including: how can we best present complex genetic/genomic information to patients to ensure that patients understand the information and can make informed decisions? What are the specific information and support needs of patients and families to be able to make decisions that are in line with their values? In collaboration with investigators from the Harvard Reproductive Endocrine Sciences Center at the Massachusetts General Hospital, this project broadly aims to examine patient understanding and factors affecting decisions surrounding genetic testing. Using the paradigm of a rare genetic disorder (isolated gonadotropin releasing hormone [GnRH] deficiency - hypogonadotropic hypogonadism/Kallmann syndrome [HH/KS]) we will examine the views and perspectives of patients and healthcare professionals alike regarding genetic/genomic information and testing with the intention of identifying patient-centered responses to these unmet needs and challenges.
Salivary Testosterone in Men: Diurnal Variation and Post-Prandial Responses
HypogonadismMaleThe purpose is to evaluate Sal-T against standard biomarkers of male gonadal status based on serum T, calculated free T and BAT. The optimal salivary sampling in terms of fasting and time of day will also be defined. The ultimate aim is to add Sal-T into the Trust's repertoire of tests in investigating suspected hypogonadism in men.
A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired...
Secondary HypogonadismThis is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment with the 12.5 mg or 25 mg Androxal or AndroGel 1.62%.
A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired...
Secondary HypogonadismThis is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment with 12.5 mg or 25 mg Androxal or AndroGel 1.62%.
ORAL T-6: Oral Androgens in Man-6
ContraceptionHypogonadismWe propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.
An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance...
Secondary HypogonadismThe purpose of this study is to investigate the route(s) of elimination and mass balance of enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~]) 500 nanocurie [nCi]) dose of [14C]Androxal in healthy adult male subjects.
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Physical FrailtyHip Fracture2 moreThe primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether exercise training combined with testosterone replacement therapy can improve skeletal muscle strength, and lean mass, to a greater degree than exercise training alone.