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Patrick R Burns, Edward D Kim, Dustin D Ruff, Allen D Seftel
This study evaluated the effect of axillary administration of a 2% testosterone solution (Axiron(®)) in hypogonadal (HGN) men who had had a suboptimal response to treatment with a commercially available topical testosterone gel. HGN men averaging 57 years old, with a mean body mass index of 31.9 kg/m(2) and median baseline testosterone level (T-level) of 185.2 ng/dL, who had failed to reach normal T-levels with a topical testosterone gel (Androgel 1.62%, Androgel, Testim, or Fortesta) were treated with a 2% testosterone solution until T-levels reached a normal range (from ≥300 to ≤1,050 ng/dL) or for up to 9 weeks...
October 5, 2015: American Journal of Men's Health
Ethan D Grober, Alaina Garbens, Andrea Božović, Vathany Kulasingam, Majid Fanipour, Eleftherios P Diamandis
OBJECTIVE: This study aims to evaluate the accuracy of the testosterone concentrations within testosterone gels and creams manufactured by compounding pharmacies. METHODS: Ten compounding pharmacies within Toronto area were included. Pharmacies were blinded as to the nature of the study. A standardized prescription for 50 mg of compounded testosterone gel/cream applied once daily was presented to each pharmacy. Two independently compounded batches were analyzed from each pharmacy 1 month apart...
June 2015: Journal of Sexual Medicine
Heather Katz, Eugene Popov, Natasha Bray, Barry Berman
Mesenteric vein thrombosis is a rare but potentially lethal cause of abdominal pain. It is usually caused by prothrombotic states that can either be hereditary or acquired. Testosterone supplementation causes an acquired prothrombotic state by promoting erythropoeisis thus causing a secondary polycythaemia. We report a case of a 59-year-old man with a history of chronic obstructive pulmonary disease (COPD) stage III, who presented with abdominal pain. Evaluation revealed an elevated haemoglobin and haematocrit, a superior mesenteric vein thrombosis on CT and a negative Janus kinase 2 mutation...
October 21, 2014: BMJ Case Reports
Claire Pexman-Fieth, Hermann M Behre, Alvaro Morales, Natalia Kan-Dobrosky, Michael G Miller
AIMS AND METHODS: This was a 6-month, open label, multinational, observational study in hypogonadal men treated with daily titrated dose of 50, 75, or 100 mg 1% testosterone gel (AndroGel®) in community practice. Primary outcome was effect of treatment on hypogonadal symptoms and quality of life as assessed by Aging Males' Symptoms (AMS) scale. Secondary objectives included erectile dysfunction (International Index of Erectile Function [IIEF]), fatigue (Multidimensional Fatigue Inventory [MFI]), and surrogates for body composition (waist circumference, body mass index [BMI])...
March 2014: Aging Male: the Official Journal of the International Society for the Study of the Aging Male
Ronald Wiehle, Glenn R Cunningham, Nelly Pitteloud, Jenny Wike, Kuang Hsu, Gregory K Fontenot, Michele Rosner, Andrew Dwyer, Joseph Podolski
OBJECTIVES: To determine the pharmacodynamic (PD) profile of serum total testosterone levels (TT) and luteinizing hormone (LH) in men with secondary hypogonadism following initial and chronic daily oral doses of enclomiphene citrate in comparison to transdermal testosterone. To determine the effects of daily oral doses of enclomiphene citrate (Androxal®) in comparison to transdermal testosterone on other hormones and markers in men with secondary hypogonadism. PATIENTS AND METHODS: This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6...
July 12, 2013: BJU International
Gary Blick
OBJECTIVES: To determine the incidence of hypogonadism in men with human immunodeficiency virus (HIV)/acquired immunodeficiency virus (AIDS), the most useful serum testosterone measurement and threshold for diagnosing hypogonadism, and the comparative efficacy of 2 testosterone replacement therapy (TRT) 1% gels (AndroGel® [Abbott Laboratories] and Testim® [Auxilium Pharmaceuticals, Inc.]). DESIGN AND SUBJECTS: This was a 2-stage observational study. In stage 1, patient records from 2 medical practices specializing in HIV/AIDS were reviewed...
March 2013: Postgraduate Medicine
C-H Liao, Y-N Wu, F-Y Lin, W-K Tsai, S-P Liu, H-S Chiang
Circulating endothelial progenitor cells (EPCs) are bone marrow-derived cells required for endothelial repair. A low EPC number can be considered as an independent predictor of endothelial dysfunction and future cardiovascular events. Recent evidence shows that patients with hypogonadal symptoms without other confounding risk factors have a low number of circulating progenitor cells (PCs) and EPCs, thus highlighting the role of testosterone in the proliferation and differentiation of EPCs. Here, we investigate if testosterone replacement therapy (TRT) can increase circulating EPC number in men with late onset hypogonadism...
July 2013: Andrology
Michael Jay Schoenfeld, Emily Shortridge, Zhanglin Cui, David Muram
INTRODUCTION: There is limited information on adherence to topical testosterone replacement therapy (TRT) among hypogonadal men. AIM: To determine adherence rates among men treated with topical testosterone gels and to examine factors that may influence adherence, including age, presence of a specific diagnosis, and index dose. METHODS: Included were 15,435 hypogonadal men, from the Thomson Reuters MarketScan Database, who had an initial topical testosterone prescription in 2009 and who were followed for 12 months...
May 2013: Journal of Sexual Medicine
Arthur L Burnett, Natalia Kan-Dobrosky, Michael G Miller
INTRODUCTION: Although testosterone replacement therapy (TRT) is the preferred treatment for hypogonadism, information for patients using testosterone includes too frequent or prolonged erections as a potential side effect. AIM: To assess the frequency and risk of priapism or related adverse events (AEs) in hypogonadal men treated with a 1% testosterone gel. METHODS: Safety and tolerability data for AndroGel 1% were assessed, including three randomized, controlled clinical trials in varying populations of hypogonadal or near hypogonadal men...
April 2013: Journal of Sexual Medicine
Xuewen Wang, Gordon I Smith, Bruce W Patterson, Dominic N Reeds, Janine Kampelman, Faidon Magkos, Bettina Mittendorfer
Men and women with hyperandrogenemia have a more proatherogenic plasma lipid profile [e.g., greater triglyceride (TG) and total and low-density lipoprotein-cholesterol and lower high-density lipoprotein-cholesterol concentrations] than healthy premenopausal women. Furthermore, castration of male rats markedly reduces testosterone availability below normal and decreases plasma TG concentration, and testosterone replacement reverses this effect. Testosterone is, therefore, thought to be an important regulator of plasma lipid homeostasis...
March 15, 2012: American Journal of Physiology. Endocrinology and Metabolism
Ernani Luis Rhoden, Abraham Morgentaler
INTRODUCTION: Despite increasing medical interest in testosterone therapy (TTh) for men with testosterone deficiency (TD) there is limited information regarding subjective response rates and acceptability of medium- to long-term TTh in routine clinical practice. AIM: To evaluate results in a consecutive series of men in clinical practice treated with TTh. MATERIAL AND METHODS: A chart review was performed for a consecutive series of men for whom TTh was initiated over 1 year for a clinical diagnosis of TD...
January 2010: Journal of Sexual Medicine
Kishore M Lakshman, Shehzad Basaria
Transdermal testosterone gels were first introduced in the US in 2000. Since then, they have emerged as a favorable mode of testosterone substitution. Serum testosterone levels reach a steady-state in the first 24 hours of application and remain in the normal range for the duration of the application. This pharmacokinetic profile is comparable to that of testosterone patch but superior to injectable testosterone esters that are associated with peaks and troughs with each dose. Testosterone gels are as efficacious as patches and injectable forms in their effects on sexual function and mood...
2009: Clinical Interventions in Aging
Frederick Taylor, Laurence Levine
INTRODUCTION: The efficacy of oral clomiphene citrate (CC) in the treatment of male hypogonadism and male infertility (MI) with low serum testosterone and normal gonadotropin levels has been reported. AIM: The aim of this article is to evaluate CC and testosterone gel replacement therapy (TGRT) with regard to biochemical and clinical efficacy and cost. MAIN OUTCOME MEASURES: The main outcome measures were change in serum testosterone with CC and TGRT therapy, and change in the androgen deficiency in aging male (ADAM) questionnaire scores with CC therapy...
January 2010: Journal of Sexual Medicine
Andre T Guay, Ted M Smith, Laura A Offutt
INTRODUCTION: A popular treatment choice for male hypogonadism is topical testosterone gel. Two proprietary formulations, Testim Gel 1% (Auxilium Pharmaceuticals, Malvern, PA, USA) and AndroGel 1% (Solvay Pharmaceuticals, Marietta, GA, USA), are available. The recommended Testim application site is limited to the arms/shoulders, whereas AndroGel may be applied to the abdomen, shoulders, and upper arms. AIM: To compare absorption variability when applying Testim to various body sites...
September 2009: Journal of Sexual Medicine
Z Chik, A Johnston, A T Tucker, K Kirby, C A Alam
AIM: Circulating concentrations of endogenous compounds such as testosterone, complicate the analysis of pharmacokinetic parameters when these compounds are administered exogenously. This study examines the influence of three correction methods of accounting for endogenous concentrations on the determination of bioequivalence between two testosterone formulations. METHODS: 12 healthy males received 50 mg TDS-testosterone, TDS-placebo, and 50 mg Androgel in a randomized placebo controlled study...
April 2009: International Journal of Clinical Pharmacology and Therapeutics
Darla L Tharp, Isabelle Masseau, Jan Ivey, Venkataseshu K Ganjam, Douglas K Bowles
AIMS: Previous studies from our laboratory have demonstrated that testosterone increases coronary smooth muscle protein kinase C delta (PKC delta) both in vivo and in vitro and inhibits coronary smooth muscle proliferation by inducing G(0)/G(1) cell cycle arrest in a PKC delta-dependent manner. The purpose of the present study was to determine whether endogenous testosterone limits coronary neointima (NI) formation in a porcine model of post-angioplasty restenosis. METHODS AND RESULTS: Sexually mature, male Yucatan miniature swine were either left intact (IM), castrated (CM), or castrated with testosterone replacement (CMT; Androgel, 10 mg/day)...
April 1, 2009: Cardiovascular Research
Hermann M Behre, Lothar Heinemann, Alvaro Morales, Claire Pexman-Fieth
Hypogonadism is associated with a range of disease states that have significant effects on morbidity and mortality, and also affect quality of life. The ESPRIT study (Energy, Sexual desire and body PropoRtions wIth AndroGel, Testosterone 1% gel therapy) is a 6-month, multinational, open label, observational study in hypogonadal men being treated with transdermal AndroGel in usual daily clinical practice; 1,700-2,400 patients will be enrolled in Canada, Germany, Central and Eastern Europe, Russia and the Middle East...
June 2008: Aging Male: the Official Journal of the International Society for the Study of the Aging Male
James D Scott, Peter R Wolfe, Peter Anderson, Gary R Cohan, Anthony Scarsella
PURPOSE: Testosterone replacement therapy via deep intramuscular injections causes extraphysiologic variations in serum testosterone concentrations. A topical transdermal testosterone gel formulation (AndroGel(R)) provides sustained physiologic concentrations of serum testosterone. The objective of this open-label switch study was to compare pharmacokinetics, safety, tolerability, and efficacy of delivery of daily testosterone gel versus intramuscular testosterone injection every 1 or 2 weeks in hypogonadal human immunodeficiency virus (HIV)-infected men...
November 2007: HIV Clinical Trials
E B Mazo, S I Gamidov, V V Iremashvili, E M Sotnikova
The aim of the trial was assessment of efficacy of combined therapy with testosterone drug (androgel) and wardenafil in patients with erectile dysfunction (ED) and metabolic syndrome (MS). The trial included 16 males with organic ED, laboratory and clinical symptoms of hypogonadism and MS (mean age 63.8 +/- 8.4) who had failed monotherapy with phosphodiesterase of type 5 (FDE-5). Both routine methods and special methods of ED and MS diagnosis with application of International Index of Erectile Function were used in examination...
July 2007: Urologii︠a︡
E D Grober, M Khera, S D Soni, M G Espinoza, L I Lipshultz
The study objective was to evaluate the efficacy of changing testosterone gel preparations among suboptimally responsive hypogonadal men. The records of all hypogonadal men on gel (Testim or Androgel) testosterone replacement therapy (TRT) were reviewed to identify men who underwent a brand substitution in gel TRT due to initial suboptimal response. Total and free serum testosterone levels and the presence of hypogonadal symptoms (ADAM) were compared pre- and post-gel substitution. Of the 370 hypogonadal men on testosterone gel replacement therapy, 75 (20%) underwent a brand substitution...
March 2008: International Journal of Impotence Research
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