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Testosterone and "Age-Related Hypogonadism" - FDA Concerns. 26287846 2015 08 25 2016 11 25 1533-4406 373 8 2015 Aug 20 The New England journal of medicine N. Engl. J. Med. Testosterone and "Age-Related Hypogonadism"--FDA Concerns. 689-91 10.1056/NEJMp1506632 Nguyen Christine P CP From the Food and Drug Administration, Silver Spring, MD. Hirsch Mark S MS Moeny David D Kaul Suresh S Mohamoud Mohamed M Joffe Hylton V HV eng Journal Article United States N Engl J Med 0255562 0028-4793 3XMK78S47O (...) Testosterone AIM IM Advertising as Topic Age Factors Aged Cardiovascular Diseases chemically induced Drug Industry Drug Labeling legislation & jurisprudence Government Regulation Humans Hypogonadism drug therapy Male Middle Aged National Academies of Science, Engineering, and Medicine (U.S.) Health and Medicine Division Off-Label Use Testosterone adverse effects blood therapeutic use United States United States Food and Drug Administration 2015 8 20 6 0 2015 8 20 6 0 2015 8 26 6 0 ppublish 26287846 10.1056
Effects of Testosterone Administration for 3 Years on Subclinical Atherosclerosis Progression in Older Men With Low or Low-Normal Testosterone Levels: A Randomized Clinical Trial. Testosterone use in older men is increasing, but its long-term effects on progression of atherosclerosis are unknown.To determine the effect of testosterone administration on subclinical atherosclerosis progression in older men with low or low-normal testosterone levels.Testosterone's Effects on Atherosclerosis (...) Progression in Aging Men (TEAAM) was a placebo-controlled, double-blind, parallel-group randomized trial involving 308 men 60 years or older with low or low-normal testosterone levels (100-400 ng/dL; free testosterone <50 pg/mL), recruited at 3 US centers. Recruitment took place between September 2004 and February 2009; the last participant completed the study in May 2012.One hundred fifty-six participants were randomized to receive 7.5 g of 1% testosterone and 152 were randomized to receive placebo gel
Comparative Safety of Testosterone Dosage Forms Increases in testosterone use and mixed reports of adverse events have raised concerns about the cardiovascular safety of testosterone. Testosterone is available in several delivery mechanisms with varying pharmacokinetics; injections cause spikes in testosterone levels, and transdermal patches and gels cause more subtle but sustained increases. The comparative cardiovascular safety of gels, injections, and patches has not been studied.To (...) determine the comparative cardiovascular safety of testosterone injections, patches, and gels.A retrospective cohort study was conducted using administrative claims from a commercially insured (January 1, 2000, to December 31, 2012) and Medicare (January 1, 2007, to December 31, 2010) population in the United States and general practitioner records from the United Kingdom (January 1, 2000, to June 30, 2012). Participants included men (aged ≥18 years) who initiated use of testosterone patches, gels
Testosterone in Men with Erectile Dysfunction with No Symptoms of Hypogonadism Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. Rapid responses should (...) study only. It may not be copied, posted on a web site, redistributed by email or stored on an electronic system without the prior written permission of CADTH or applicable copyright owner. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners’ own terms and conditions. TITLE: Testosterone in Men with Erectile Dysfunction
Testosterone and Cardiovascular Health: Safety of Treatment of Hypogonadism. Controversy has arisen over the issue of the cardiovascular safety of testosterone.The aim of this article is to examine the evidence as to the cardiovascular safety involved with the administration of testosterone.A literature review was performed with regard to cardiovascular safety of testosterone.The main outcome measure was to evaluate the available evidence as to cardiovascular safety and risk of testosterone.A (...) handful of recently published and widely discussed manuscripts have suggested that administration of testosterone replacement therapy increases the frequency of adverse cardiovascular events. In contrast, there have been recent clinical reports suggesting that testosterone is either safe or actually reduces cardiovascular events and mortality. All of these studies-both those suggesting that testosterone has adverse effects, as well as those suggesting it has positive effects on the cardiovascular
Testosterone testing Final Testosterone Testing: Findings & Decision Page 1 of 3 Health Technology Clinical Committee Final Findings and Decision Topic: Testosterone Testing Meeting Date: March 20, 2015 Final Adoption: May 15, 2015 Meeting materials and transcript are available on the HTA website: www.hca.wa.gov/hta/meetingmaterials/Forms/ExtMeetingMaterials.aspx Number and Coverage Topic: 20150320A – Testosterone Testing HTCC Coverage Determination: Testosterone testing is a covered benefit (...) of testosterone therapy Non-covered Indicators: N/A This decision does not apply to females, males under age 18, or transgender persons. Agency Contact Information: Agency Phone Number Labor and Industries 1-800-547-8367 Public Employees Health Plan 1-800-200-1004 Washington State Medicaid 1-800-562-3022 WA - Health Technology Assessment March 20, 2015 Final Testosterone Testing: Findings & Decision Page 2 of 3 HTCC Coverage Vote and Formal Action Committee Decision Based on the deliberations of key health
Effect of Testosterone Treatment on Glucose Metabolism in men With Type 2 Diabetes: A Randomized Controlled Trial To determine whether testosterone therapy improves glucose metabolism in men with type 2 diabetes (T2D) and lowered testosterone.We conducted a randomized, double-blind, parallel, placebo-controlled trial in 88 men with T2D, aged 35-70 years with an HbA1c ≤8.5% (69 mmol/mol), and a total testosterone level, measured by immunoassay, of ≤12.0 nmol/L (346 ng/dL). Participants were (...) randomly assigned to 40 weeks of intramuscular testosterone undecanoate (n = 45) or matching placebo (n = 43). All study subjects were included in the primary analysis. Seven men assigned to testosterone and six men receiving placebo did not complete the study. Main outcome measures were insulin resistance by homeostatic model assessment (HOMA-IR, primary outcome) and glycemic control by HbA1c (secondary outcome).Testosterone therapy did not improve insulin resistance (mean adjusted difference [MAD
Testosterone supplementation and sexual function: a meta-analysis study Testosterone supplementation and sexual function: a meta-analysis study | ECE2014 | 16th European Congress of Endocrinology | Endocrine Abstracts Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online) Menu P955 Endocrine Abstracts (2014) 35 P955 | DOI: Testosterone supplementation and sexual function: a meta-analysis study Giovanni Corona 1 , Andrea M (...) and Reggio Emilia and Azienda USL of Modena, Modena, Italy. Introduction: The role of testosterone supplementation (TS) as a possible treatment for male sexual dysfunction remains questionable. The aim of the present study is to meta-analyse data evaluating the effects of TS on male sexual function and its therapeutic synergism with the use of phosphodiesterase type 5 (PDE5i). Methods: An extensive Medline Embase and Cochrane search was performed including the following words: testosterone, erectile
Natesto (testosterone) Nasal Gel Drug Approval Package: Brand Name (Generic Name) NDA # Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Natesto (testosterone) Nasal Gel Company: Trimel Biopharma, Inc. Application No.: 205488 Approval Date: 5/28/2014 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) Date created
Testosterone for low sexual desire in nonsurgically postmenopausal women Testosterone for low sexual desire in nonsurgically postmenopausal women Testosterone for low sexual desire in nonsurgically postmenopausal women Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation Testosterone for low sexual desire in nonsurgically postmenopausal women. Lansdale: HAYES, Inc (...) .. Directory Publication. 2013 Authors' conclusions Endogenous androgens such as testosterone are thought to play a role in the regulation of sexual desire, and the goal of testosterone therapy for nonsurgically postmenopausal women is to increase sexual desire. Final publication URL The report may be purchased from: Indexing Status Subject indexing assigned by CRD MeSH Females; Libido; Postmenopause; Sexual Dysfunctions, Psychological; Testosterone Language Published English Country of organisation United
Medicalization of aging and the testosterone deficiency syndrome Servicio Navarro de Salud / Osasunbidea Plaza de la Paz, s/n - 31002 Pamplona T 848429047 - F 848429010 firstname.lastname@example.org Drug and Therapeutics Bulletin of Navarre. Spain abstract n Objective: to carry out a critical appraisal of the Testosterone Deficit Syndrome (TDS), also known as low testosterone or T-low, its diagnosis and management. Materials and methods: a bibliographic search was carried out in the TRIP (...) database and PubMed with the following key words: “testosterone deficiency”, “late-onset hypogonadism”, “male andropause” and “androgen deficiency in aging males” filtered by the type of study (clinical practice guidelines, systematic reviews, meta-analyses or clinical trials). Information on consumption and sales was obtained from invoiced prescriptions in Navarre from 2001 upto 2011. Results: many of the signs and symptoms that define this syndrome overlap with those produced by other health problems
What Is Andropause? Is Testosterone Supplementation the Answer in Older Men? What Is Andropause? Is Testosterone Supplementation the Answer in Older Men? – Clinical Correlations Search What Is Andropause? Is Testosterone Supplementation the Answer in Older Men? September 20, 2012 5 min read By Kylie Birnbaum Faculty Peer Reviewed Women have long bemoaned menopause and its physiological, psychological, and sexual effects. Fortunately, hormone replacement therapy has provided relief (...) for symptomatic women. Less attention is paid to men, who also experience declines in their sex hormones. Decreased testosterone may explain many symptoms experienced by elderly men, such as poor sexual function and libido, decreased bone mineral density, fatigue, and decreased muscle mass and strength. Should physicians treat elderly men with testosterone replacement therapy? Late-onset hypogonadism, or “andropause,” is the gradual decline in testosterone levels in aging men. It differs from menopause
Effect of testosterone supplementation with and without a dual 5Î±-reductase inhibitor on fat-free mass in men with suppressed testosterone production: a randomized controlled trial. Steroid 5α-reductase inhibitors are used to treat benign prostatic hyperplasia and androgenic alopecia, but the role of 5α-dihydrotestosterone (DHT) in mediating testosterone's effects on muscle, sexual function, erythropoiesis, and other androgen-dependent processes remains poorly understood.To determine whether (...) testosterone's effects on muscle mass, strength, sexual function, hematocrit level, prostate volume, sebum production, and lipid levels are attenuated when its conversion to DHT is blocked by dutasteride (an inhibitor of 5α-reductase type 1 and 2).The 5α-Reductase Trial was a randomized controlled trial of healthy men aged 18 to 50 years comparing placebo plus testosterone enthanate with dutasteride plus testosterone enanthate from May 2005 through June 2010.Eight treatment groups received 50, 125, 300
Effect of 1 Week of Sleep Restriction on Testosterone Levels in Young Healthy MenFREE 21632481 2011 06 03 2018 11 13 1538-3598 305 21 2011 Jun 01 JAMA JAMA Effect of 1 week of sleep restriction on testosterone levels in young healthy men. 2173-4 10.1001/jama.2011.710 Leproult Rachel R Department of Medicine, University of Chicago, Chicago, Illinois, USA. Van Cauter Eve E eng P60DK-020595 DK NIDDK NIH HHS United States 5R01HL72694-5 HL NHLBI NIH HHS United States M01 RR000055 RR NCRR NIH HHS (...) United States MO1-RR-00055 RR NCRR NIH HHS United States R01 HL072694 HL NHLBI NIH HHS United States P60 DK020595 DK NIDDK NIH HHS United States Journal Article Research Support, N.I.H., Extramural United States JAMA 7501160 0098-7484 3XMK78S47O Testosterone WI4X0X7BPJ Hydrocortisone AIM IM Adult Fatigue Humans Hydrocortisone blood Male Sleep Deprivation physiopathology Testosterone blood deficiency Young Adult 2011 6 3 6 0 2011 6 3 6 0 2011 6 4 6 0 ppublish 21632481 305/21/2173 10.1001/jama.2011.710
Reduction in 24-hour plasma testosterone levels in subjects who showered 15 or 30 minutes after application of testosterone gel. To investigate whether showering, to prevent the involuntary transfer of testosterone to others through skin contact, either 15 or 30 minutes after application of testosterone gel would significantly affect plasma testosterone levels.Prospective 3-way crossover trial.University hospital in the Netherlands.Ten agonadal female-to-male transsexuals who had sex (...) -reassignment surgery at least 3 months earlier.Subjects were randomized to one of three application regimens for testosterone gel 50 mg/day, each lasting 7 days: testosterone application after showering (standard regimen), shower was taken 30 minutes after testosterone application, or shower was taken 15 minutes after testosterone application. Subjects then crossed over to each of the other two application regimens for a total of 21 days of study participation.On day 7 of each application regimen, mean
Incomplete testosterone suppression in prostate cancer. 21067409 2010 11 30 2013 11 21 1533-4406 363 20 2010 Nov 11 The New England journal of medicine N. Engl. J. Med. Incomplete testosterone suppression in prostate cancer. 1976 10.1056/NEJMc1010187 Crawford E David ED Rove Kyle O KO eng Letter United States N Engl J Med 0255562 0028-4793 0 Androgen Antagonists 33515-09-2 Gonadotropin-Releasing Hormone 3XMK78S47O Testosterone AIM IM Androgen Antagonists pharmacology therapeutic use (...) Gonadotropin-Releasing Hormone agonists antagonists & inhibitors Humans Male Prostatic Neoplasms blood drug therapy mortality Testosterone blood 2010 11 12 6 0 2010 11 12 6 0 2010 12 14 6 0 ppublish 21067409 10.1056/NEJMc1010187