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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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PubMed Articles [1357 Associated PubMed Articles listed on BioPortfolio]

Effects of clomiphene citrate on male obesity-associated hypogonadism: a randomized, double-blind, placebo-controlled study.

Obesity causes secondary hypogonadism (HG) in men. Standard testosterone (T) replacement therapy improves metabolic parameters but leads to infertility.

Novel Therapy for Male Hypogonadism.

Hypogonadism and the treatment of low testosterone is increasingly a subject of medical inquiry and controversy. The few treatments that are FDA-approved such as testosterone topicals, injections, and...

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'.

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Single-Centre Experience of Testosterone Therapy for Boys with Hypogonadism.

Hypogonadism in boys is one of the commonest conditions encountered in paediatric endocrinology.

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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