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NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)

2014-07-23 21:09:44 | BioPortfolio

Summary

The design of the study is a standard double-blind design, which is needed in this study to allow for unbiased evaluation of efficacy and safety. The effect of the additional impact of testosterone replacement therapy in hypogonadal men on muscle strength and quality of life in comparison to physical exercise alone will be assessed. Treatment duration will be 54 weeks, to monitor the increase as well as the "steady state" of the parameters assessed.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Hypogonadism

Intervention

Testosterone Undeconate (Nebido, BAY86-5037), Placebo

Location

Köln
Nordrhein-Westfalen
Germany
50931

Status

Not yet recruiting

Source

Bayer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:44-0400

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Efficacy and Tolerability of Testogel/Nebido in Combination With Exercise and Diet in Hypogonadal Male Patients

With advancing age testosterone levels decline in men. Low testosterone levels plus certain symptoms are called "Late Onset Hypogonadism (LOH)". Adipose tissue may contribute to testostero...

Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis

Both conditions hypogonadism and immobilisation (paraplegia) may contribute or lead to decreased bone mineral density resp osteoporosis. In this study bone mineral density is assessed in h...

Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice

This is an observational study with a drug called Nebido, a new testosterone replacement therapy, which is available for the treatment of male hypogonadism. The benefit and safety of Nebid...

Nebido Versus Placebo in Elderly Men With Typical Symptoms of Late Onset Hypogonadism Over a Period of 54 Weeks

To evaluate the safety and efficacy of Nebido compared to placebo in elderly men aged 50 and over with symptomatic late onset hypogonadism

The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men

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PubMed Articles [1317 Associated PubMed Articles listed on BioPortfolio]

Topical Testosterone Therapy Adherence and Outcomes Among Men With Primary or Secondary Hypogonadism.

Men with primary or secondary hypogonadism (HG) prescribed testosterone therapy (TTh) who terminate treatment early might not obtain the benefit of symptom relief.

The marketing of testosterone treatments for age-related low testosterone or 'Low T'.

To summarize the research evidence on promotion of testosterone for 'Low T', or age-related hypogonadism.

Low Serum Testosterone in Outpatient Psychiatry Clinics: Addressing Challenges to the Screening and Treatment of Hypogonadism.

The symptoms of low testosterone frequently overlap with psychiatric complaints including depression and fatigue. Testosterone repletion has been shown to improve mood symptoms in men with low testost...

EAA clinical guideline on management of bone health in the andrological outpatient clinic.

Male osteoporosis is now a well-recognized medical disorder with established clinical guidelines for both diagnosis and management. Prevention as well as management of osteoporosis in men consulting t...

Screening for Hypogonadism in Primary Healthcare: How to do this Effectively.

Testosterone, the most important androgen produced by the testes, plays an integral role in male health. Testosterone levels are increasingly being checked in primary healthcare as awareness of the ri...

Medical and Biotech [MESH] Definitions

Condition resulting from deficient gonadal functions, such as GAMETOGENESIS and the production of GONADAL STEROID HORMONES. It is characterized by delay in GROWTH, germ cell maturation, and development of secondary sex characteristics. Hypogonadism can be due to a deficiency of GONADOTROPINS (hypogonadotropic hypogonadism) or due to primary gonadal failure (hypergonadotropic hypogonadism).

Steroidal compounds related to TESTOSTERONE, the major mammalian male sex hormone. Testosterone congeners include important testosterone precursors in the biosynthetic pathways, metabolites, derivatives, and synthetic steroids with androgenic activities.

A potent androgenic metabolite of TESTOSTERONE. Dihydrotestosterone (DHT) is generated by a 5-alpha reduction of testosterone. Unlike testosterone, DHT cannot be aromatized to ESTRADIOL therefore DHT is considered a pure androgenic steroid.

A potent androgenic steroid and major product secreted by the LEYDIG CELLS of the TESTIS. Its production is stimulated by LUTEINIZING HORMONE from the PITUITARY GLAND. In turn, testosterone exerts feedback control of the pituitary LH and FSH secretion. Depending on the tissues, testosterone can be further converted to DIHYDROTESTOSTERONE or ESTRADIOL.

An ester of TESTOSTERONE with a propionate substitution at the 17-beta position.

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