Androgel

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])...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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)...

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...

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...

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...

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...

The major indication for testosterone (T) treatment is male hypogonadism that is characterized by low serum T concentrations. Although a recently developed hydroalcoholic gel, Androgel, containing 1% T addresses many of the problems associated with the more conventional formulations, the bioavailability of T is only 10% requiring 5 to 10 g of gel to be applied daily. The present study was performed to investigate the effect of isopropyl alcohol (IPA) content as a penetration enhancer based on its ability to prevent skin dryness and in turn to increase T permeation from hydroalcoholic gels...

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...

A randomized, double-blind, placebo-controlled trial was conducted to (1) evaluate efficacy and safety of transdermal testosterone gel (AndroGel) for hypogonadal men in Taiwan, and (2) observe improvements in sexual function through international index of erectile function (IIEF) scores. Eligible hypogonadal men were randomized to receive 50 mg/day transdermal testosterone gel (TTG) or placebo for 3 months. Primary end point was change from baseline in total testosterone (TT) and free testosterone (FT). Secondary end points were change from baseline in serum hormone levels (such as dihydrotestosterone (DHT), estradiol (E2), luteinizing hormone (LH), follicle-stimulating hormone (FSH) and sex-hormone-binding globulin (SHBG)) and changes in IIEF scores...