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S Arver, C Stief, J de la Rosette, T H Jones, A Neijber, D Carrara
Testosterone gel formulations have become a popular testosterone replacement therapy in patients with hypogonadism since their advent in the year 2000. The gel formulations restore testosterone levels to mid-normal physiological levels (14-17.5 nmol/L) as early as within 24 h, and help alleviate the signs and symptoms of testosterone deficiency, thereby leading to an improved quality of life. Although testosterone gels have a favourable efficacy and safety profile as compared to injectable and patch formulations, risk of secondary exposure poses a challenge...
March 30, 2018: Andrology
Teresa Lam, Anne Poljak, Mark McLean, Neha Bahl, Ken K Y Ho, Vita Birzniece
CONTEXT: The urea cycle is a rate-limiting step for amino acid nitrogen elimination. The rate of urea synthesis is a true indicator of whole-body protein catabolism. Testosterone reduces protein and nitrogen loss. The effect of testosterone on hepatic urea synthesis in humans has not been studied. OBJECTIVE: To determine whether testosterone reduces hepatic urea production. DESIGN: An open-label study. PATIENTS AND INTERVENTION: Eight hypogonadal men were studied at baseline, and after two weeks of transdermal testosterone replacement (Testogel, 100 mg/day)...
April 2017: European Journal of Endocrinology
Håkan Olsson, Rikard Sandström, Anders Neijber, Dario Carrara, Lars Grundemar
This randomized, open-label, multiple-dose three-way cross-over study compared the pharmacokinetics of a new testosterone gel formulation in two strengths, testosterone gel 1% and testosterone gel 2% (FE 999303), with Testogel® in 11 testosterone-suppressed healthy men. Subjects received one of six treatment sequences; 50 mg of testosterone was administered once daily for 7 consecutive days, with different treatments separated by washout-periods of 6-9 days. Testosterone gel 1% and testosterone gel 2% displayed greater relative bioavailability (2...
September 2014: Clinical Pharmacology in Drug Development
G A Wittert, R W Harrison, M J Buckley, J Wlodarczyk
We compared a novel 5% testosterone (T) cream (AndroForte 5, Lawley Pharmaceuticals, Australia) with a 1% T gel (Testogel, Besins Healthcare, Australia). Using an open-label crossover design, subjects were randomized to one of two treatment sequences using either the T gel or T cream first in a 1 : 1 ratio. Each treatment period was 30 days with a 7-14 days washout period between them. On Days 1 and 30 of each treatment period blood was sampled at -15, -5 min, 0, 2, 4, 5, 6, 7, 8, 9, 10, 12 and 16 h post study drug administration...
January 2016: Andrology
Malcolm Carruthers, Paul Cathcart, Mark R Feneley
INTRODUCTION: Testosterone treatment has evolved rapidly over the past 25 years as new, more effective and convenient methods have become available. This study reports experience with seven different methods, introduced on the market in the UK. AIM: To establish the symptom response when testosterone treatment was initiated on the basis of clinical features and symptoms of androgen deficiency, and the resulting endocrine, biochemical and physiological responses...
2015: Aging Male: the Official Journal of the International Society for the Study of the Aging Male
Detlef Thieme, Claudia Rautenberg, Joachim Grosse, Martin Schoenfelder
The legally defensible proof of the abuse of endogenous steroids in sports is currently based on carbon isotope ratio mass spectrometry (IRMS), i.e. a comparison between (13)C/(12)C ratios of diagnostic precursors and metabolites of testosterone. The application of this technique requires a chromatographic baseline separation of respective steroids prior to IRMS detection and hence laborious sample pre-processing of the urinary steroid extracts including clean up by solid-phase extraction and/or liquid chromatography...
November 2013: Drug Testing and Analysis
Hermann M Behre, Teuvo L J Tammela, Stefan Arver, Josep R Tolrá, Vincenzo Bonifacio, Michael Lamche, Judy Kelly, Florian Hiemeyer, Erik J Giltay, Louis J Gooren
INTRODUCTION: The clinical significance of low to low-normal testosterone (T) levels in men remains debated. AIM: To analyze the effects of raising serum T on lean body mass (LBM), fat mass (FM), total body mass, and health-related quality-of-life (HRQoL). METHODS: Randomized, double-blind, placebo-controlled study. Men, aged 50-80 years, with serum total T<15 nmol/L and bioavailable T < 6.68 nmol/L, and a Aging Males' Symptoms (AMS) total score >36, received 6 months treatment with transdermal 1% T gel (5-7...
December 2012: Aging Male: the Official Journal of the International Society for the Study of the Aging Male
A D Brailsford, I Gavrilović, R J Ansell, D A Cowan, A T Kicman
The accuracy and precision of gas chromatography combustion isotope ratio mass spectrometry (GC-C-IRMS) measurements are highly dependent on analyte purity. Reliable analysis of urinary steroids for doping control therefore requires extensive and time-consuming sample preparation (i.e. liquid chromatography fraction collection) prior to GC-C-IRMS analysis. The use of two-dimensional GC (GC-GC) with heart-cutting (Deans Switch) as a possible approach to reduce the sample purification required for IRMS analysis is described herein...
December 2012: Drug Testing and Analysis
Mark R Feneley, Malcolm Carruthers
INTRODUCTION: For men with androgen deficiency on testosterone replacement therapy (TRT), clinical concern relates to the development of prostate cancer (PCa). AIM: An updated audit of prostate safety from the UK Androgen Study was carried out to analyze the incidence of PCa during long-term TRT. MAIN OUTCOME MEASURES: Diagnosis of PCa in men receiving TRT, by serum prostate-specific antigen (PSA) testing and digital rectal examination (DRE), and its relation to different testosterone preparations...
August 2012: Journal of Sexual Medicine
Alper Yurci, Mehmet Yucesoy, Kursad Unluhizarci, Edip Torun, Sebnem Gursoy, Mevlut Baskol, Kadri Guven, Omer Ozbakir
INTRODUCTION: Hypogonadism characterized by low serum testosterone level, loss of libido, small testes, impotence and gynecomastia is a common clinical situation in male patients with advanced chronic liver disease. The aim of the study was to assess the efficacy and safety of testosterone replacement on muscle strength, bone mineral density (BMD), body composition and gynecomastia in hypogonadal men with liver cirrhosis. METHODS: Sixteen hypogonadal male cirrhotic patients were included and twelve completed the study...
December 2011: Clinics and Research in Hepatology and Gastroenterology
Young-Hoon Ko, Young-Min Lew, Sung-Won Jung, Sook-Haeng Joe, Chang-Hyun Lee, Hyun-Gang Jung, Moon-Soo Lee
Although there are few studies on the treatment of schizophrenia with testosterone, several indirect findings have suggested testosterone as a possible treatment modality for schizophrenia. To explore the therapeutic effect of testosterone augmentation of antipsychotic medication on symptoms in male patients with schizophrenia, the authors performed a placebo-controlled, double-blind trial on 30 schizophrenic men, using either 5 g of 1% testosterone gel (Testogel; Besins Iscovesco, Paris, France) or a placebo added to a fixed dosage of antipsychotic medication over a period of 4 weeks with a 2-week washout period...
August 2008: Journal of Clinical Psychopharmacology
Andrea Fabbri, Elisa Giannetta, Andrea Lenzi, Andrea M Isidori
There is still considerable controversy concerning the issue of testosterone replacement therapy. This is because testosterone replacement therapy is not a 'risk-free' treatment and a randomized controlled trial to evaluate safety of prolonged testosterone replacement therapy is not available, nor is it likely to be in the near future. However, recent testosterone delivery systems, such as the 1% gel (Testogel, Androgel and Testim), have proven to have a good physiologic profile, allowing constant monitoring of the possible complications and prompt discontinuation in the event of adverse effects...
July 2007: Expert Opinion on Biological Therapy
A A Yassin, F Saad, H E Diede
The study was aimed at investigating the efficacy of tadalafil (Cialis) in combination with transdermal testosterone (Testogel) for the treatment of tadalafil-refractory erectile dysfunction in hypogonadal patients. In an open-label, retrospective trial, 69 hypogonadal nonresponders to tadalafil monotherapy (mean age: 59 years, total testosterone < or =3.4 ng ml(-1)) were randomly divided into two homogeneous groups. Group I (n = 35) received Testogel (5 g containing 50 mg testosterone, daily) for 4 weeks, followed by concurrent therapy with tadalafil (20 mg, twice a week)...
April 2006: Andrologia
J Nathorst-Böös, A Flöter, M Jarkander-Rolff, K Carlström, B von Schoultz
OBJECTIVES: To elucidate if percutanous treatment with 10mg testosterone per day could enhance sexuality and psychological well-being in postmenopausal women presenting problems with low libido. Secondary to study the influence on blood lipids, hemoglobin and erythropoietin levels. METHODS: Fifty-three postmenopausal women participated. As a complement to their already on-going HRT, 10mg of a testosterone gel (Testogel, Besins-Iscovesco) or placebo was administered...
January 10, 2006: Maturitas
Pierre Bouloux
OBJECTIVE: The aim of this work was to review the pharmacokinetic and clinical profile of Testim (Auxilium Pharmaceuticals, Norristown, Pennsylvania) 1% gel formulation of testosterone for the treatment of male hypogonadism. METHODS: An English-language search of the medical literature was conducted using PubMed (1998-December 2004) and EMBASE (1998-December 2004). Search terms included ag(e)ing male, male hypogonadism, late-onset hypogonadism, testosterone, testosterone deficiency, testosterone therapy, testosterone replacement therapy, androgen therapy, testosterone gel, and Testim...
March 2005: Clinical Therapeutics
F Jockenhövel
Testosterone therapy has been used for more than 60 years in the treatment of male hypogonadism. The classical forms of hypogonadism are comprised of primary testicular failure or insufficient testicular stimulation due to the lack of pituitary gonadotropins. Typical causes of primary hypogonadism are Klinefelter's syndrome, anorchia or acquired disturbances of testicular function. Secondary hypogonadism is characterized by insufficient production of pituitary gonadotropins, due either to pituitary failure or defects at the hypothalamic level...
December 2004: Aging Male: the Official Journal of the International Society for the Study of the Aging Male
R Shabsigh
Studies in animals have indicated that the nitric oxide erectile pathway is testosterone-dependent. Castration induces erectile dysfunction and a reduction in nitric oxide synthase-stained nerves in erectile tissue. Furthermore, castration adversely affects penile hemodynamics and smooth muscle content, leading to veno-occlusive dysfunction. Testosterone replenishment reverses these physiological, biochemical and structural changes. Several clinical studies have demonstrated the benefits of a combination of testosterone and sildenafil...
December 2004: Aging Male: the Official Journal of the International Society for the Study of the Aging Male
Asjad Hameed, Theresa Brothwood, Pierre Bouloux
Optimal testosterone replacement therapy remains a considerable challenge for the estimated five out of 1000 men in the general community with androgen deficiency. Oral delivery is not possible due to rapid first pass metabolism and short half-life. Testosterone derivatives have been developed to enhance intrinsic androgenic potency, prolong duration of action, or improve oral bioavailability of synthetic androgens. Structural modification of testosterone include 17 beta-esterification, 17 alpha-alkylation, 1-methylation, addition of a 19-normethyl group, and 7 alpha-methylation...
October 2003: Current Opinion in Investigational Drugs
R S Swerdloff, C Wang
Transdermal testosterone gels represent an effective alternative to injectable testosterone preparations. Short-term (6 months) data demonstrated positive effects on muscle, bone, fat, libido and mood. This report provides a preliminary analysis of longer-term treatment with a testosterone gel (AndroGel or Testogel) in a group of men aged 19-67 years of age. The positive effects of testosterone treatment on all of the above parameters persisted in this 3-year follow-up. The benefits occurred independent of age (equally in the older and younger subjects)...
September 2003: Aging Male: the Official Journal of the International Society for the Study of the Aging Male
F Jockenhövel
Several epidemiological studies have demonstrated a gradual decrease of serum testosterone with aging in men. A considerable number of men will experience hypogonadal androgen levels, defined by the normal range for young men. Thus, in addition to the long-standing use of androgen replacement therapy in the classical forms of primary and secondary hypogonadism, age-associated testosterone deficiency has led to considerable developments in application modes for testosterone. Since oral preparations of testosterone are ineffective, due to the first-pass effect of the liver, or, in case of 17 alpha-alkylation, cause hepatotoxicity, intramuscular injection of long-acting esters, such as testosterone enanthate, have been the mainstay of testosterone therapy...
September 2003: Aging Male: the Official Journal of the International Society for the Study of the Aging Male
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