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Showing 1-10 of 10 trials
NCT03721497
Bariatric surgery is an effective method in the treatment of severe obesity and type 2 diabetes mellitus achieving high remission rates. However, weight loss also causes loss of skeletal muscle and bone mass which at least partly could be prevented by exercise and dietary intervention although the counselling of obese and sedentary individuals in order to increase their physical activity presents a challenge. As up to 78.8% of men undergoing bariatric surgery have low levels of testosterone, testosterone therapy could be considered an attractive alternative or supplement to prevent the immense loss of muscle mass during weight loss. Furthermore, low testosterone levels are associated with sarcopenia, insulin resistance, increased body fat, reduced quality of life, loss of libido and reduced sexual function. The study is a long-term randomized, placebo-controlled trial investigating the effects of testosterone therapy combined with exercise and diet counselling on body composition, components of the metabolic syndrome, hormones, inflammation, sexual function and quality of life before and after weight loss in obese, hypogonadal men undergoing bariatric surgery.
NCT04708249
D-chiroinositol (DCI), is known as second messenger of insulin pathway, but recently several works have reported the influence of DCI on steroidogenesis. In particular, the DCI capabilities to regulate aromatase expression and testosterone biosynthesis are arising. In this regard, DCI administration in case of reduced levels of testosterone, could be a good therapeutic opportunity. For this reason, the treatment of Late-Onset Male Hypogonadism (LOH) in undoubtedly an interesting target. LOH is a reduction of testosterone level due to advancing age, currently treated with Testosterone Replacement Therapy (TRT). Unfortunately, there is a lack of information about TRT safety, especially in older men. For these reasons, the aim of this study is to evaluate the effect of DCI treatment on testosterone accumulation in LOH patient.
NCT00911586
The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.
NCT02966652
DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency in men. The study was a Phase 1 clinical study in hypogonadal men, defined according to FDA and Endocrine Society Guidelines, designed to evaluate the pharmacokinetic (PK) characteristics of DITEST, and to assess the safety and tolerability of DITEST in the target population.
NCT01765179
The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.
NCT01665599
This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations \<300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator.
NCT02081300
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
NCT01228071
This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal testosterone range after initial testosterone gel 2% application, time to steady state after after initiation of testosterone gel 2%, and drying time after application of testosterone gel 2%.
NCT02715713
The primary goal of this pilot study is to investigate the association between testosterone deficiency and the presence of abnormalities in the function of the autonomic nervous system. If such association exists, then we will investigate the effect of testosterone replacement therapy on correcting these abnormalities.
NCT00858650
The primary objective of the Registry of HYpogonadism in MEn (RHYME) is to establish and maintain a large, multi-national prospective registry of male patients who have been diagnosed with male hypogonadism (HG), also known as androgen deficiency or testosterone deficiency.