Recruitment and Screening for the Testosterone Trials

Cauley, Jane A.; Fluharty, Laura; Ellenberg, Susan S.; Gill, Thomas M.; Ensrud, Kristine E.; Barrett‐Connor, Elizabeth; Cifelli, Denise; Cunningham, Glenn R.; Matsumoto, Alvin M.; Bhasin, Shalender; Pahor, Marco; Farrar, John T.; Cella, David; Rosen, Raymond C.; Resnick, Susan M.; Swerdloff, Ronald S.; Lewis, Cora E.; Molitch, Mark E.; Crandall, Jill P.; Stephens‐Shields, Alisa J.; Strorer, Thomas W.; Wang, Christina; Anton, Stephen D.; Basaria, Shehzad; Diem, Susan J.; Tabatabaie, Vafa; Dougar, Darlene; Hou, Xiaoling; Snyder, Peter J.

doi:10.1093/gerona/glv031

Cited by 28 publications

(27 citation statements)

References 15 publications

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“…S1 in the Supplementary Appendix). 11 Relatively few men had a sufficiently low testosterone level to qualify; only 4700 of 21,940 men (21.4%) who had blood sampled qualified by the first measurement and 1490 of 2163 men (68.9%) qualified by the second, for an overall inclusion rate by testosterone level of 14.7%. 11 …”

Section: Resultsmentioning

confidence: 99%

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Effects of Testosterone Treatment in Older Men

et al. 2016

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BACKGROUND Serum testosterone concentrations decrease as men age, but benefits of raising testosterone levels in older men have not been established. METHODS We assigned 790 men 65 years of age or older with a serum testosterone concentration of less than 275 ng per deciliter and symptoms suggesting hypoandrogenism to receive either testosterone gel or placebo gel for 1 year. Each man participated in one or more of three trials — the Sexual Function Trial, the Physical Function Trial, and the Vitality Trial. The primary outcome of each of the individual trials was also evaluated in all participants. RESULTS Testosterone treatment increased serum testosterone levels to the mid-normal range for men 19 to 40 years of age. The increase in testosterone levels was associated with significantly increased sexual activity, as assessed by the Psychosexual Daily Questionnaire (P<0.001), as well as significantly increased sexual desire and erectile function. The percentage of men who had an increase of at least 50 m in the 6-minute walking distance did not differ significantly between the two study groups in the Physical Function Trial but did differ significantly when men in all three trials were included (20.5% of men who received testosterone vs. 12.6% of men who received placebo, P=0.003). Testosterone had no significant benefit with respect to vitality, as assessed by the Functional Assessment of Chronic Illness Therapy–Fatigue scale, but men who received testosterone reported slightly better mood and lower severity of depressive symptoms than those who received placebo. The rates of adverse events were similar in the two groups. CONCLUSIONS In symptomatic men 65 years of age or older, raising testosterone concentrations for 1 year from moderately low to the mid-normal range for men 19 to 40 years of age had a moderate benefit with respect to sexual function and some benefit with respect to mood and depressive symptoms but no benefit with respect to vitality or walking distance. The number of participants was too few to draw conclusions about the risks of testosterone treatment. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT00799617.)

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Section: Resultsmentioning

confidence: 99%

“…11 Respondents were screened first by telephone interview and then during two clinic visits. Eligibility criteria included an age of 65 years or older and serum testosterone levels that averaged less than 275 ng per deciliter.…”

Section: Methodsmentioning

confidence: 99%

Effects of Testosterone Treatment in Older Men

et al. 2016

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“…Although testosterone replacement of hypogonadal men with presumed normal aromatization activity is a logical trial choice (with obvious attention to extraskeletal risk and benefit), intriguing pilot studies also suggest a potential bone benefit from selective estrogen receptor modulators in men with low estradiol levels (34,35). Indeed, the results of the bone trial substudy of the testosterone trials are eagerly awaited, as demonstration of inadequate bone mineral density improvement in men who remain estrogen deficient despite normalization of androgen status would confirm and extend the findings of Finkelstein and colleagues and further establish estrogen signaling as a potential target for osteoporosis treatment in men (17,36). Notwithstanding these observations, there is also evidence that serum levels of estrogen (and testosterone) may not provide additional utility in the prospective prediction of osteoporotic fractures, which is obviously integral to potential clinical utility of such measurements (37).…”

Section: Unresolved Issues/future Directionsmentioning

confidence: 82%

Battle of the sex steroids in the male skeleton: and the winner is…

Weber¹

2016

Journal of Clinical Investigation

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“…We selected CCTA as the imaging modality to assess coronary atherosclerosis in this trial. Until recently, estimating the plaque progression was only possible using intravascular ultrasound (IVUS), an invasive approach that shows only proximal coronary artery plaque volumes and correlates poorly with the individual total plaque burden [9,40]. It is also invasive and expensive, with well-defined associated morbidity.…”

Section: Discussionmentioning

confidence: 99%

“…The TTrials include 12 clinical sites geographically distributed across the United States and is sponsored by the National Institute on Aging (NIA), National Institute of Neurological Disorders and Stroke (NINDS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI), and AbbVie, Inc. Men ≥65 years who had a mean serum testosterone concentration <275 ng/dL on two morning measures, who had subjective complaints and objective evidence of sexual dysfunction, physical dysfunction and/or reduced vitality (clinical conditions thought to be potentially improved by testosterone supplementation), and who were not at elevated risk for prostate, cardiovascular or hematologic problems associated with high levels of testosterone, were recruited; those eligible and consenting were assigned to one year of treatment with testosterone therapy or placebo [8,9]. The Cardiovascular Trial, designed to determine the effect of testosterone on the progression of coronary atherosclerosis, was conducted at 9 of the 12 TTrials sites.…”

Section: Methodsmentioning

confidence: 99%

The Cardiovascular Trial of the Testosterone Trials

Alamir

Ellenberg

Swerdloff

et al. 2016

Coronary Artery Disease

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Background Data from prior studies have yielded inconsistent results regarding the association of serum testosterone levels with the risk of cardiovascular disease (CVD). There are no clinical trial data on the effects of testosterone replacement therapy on plaque progression. Objective We designed a study to investigate the effect of testosterone therapy on coronary artery plaque progression using serial coronary computed tomographic angiography (CCTA). In this paper we describe the study design, methods, and characteristics of the study population. Methods The Cardiovascular Trial of The Testosterone Trials (TTrials) (NCT00799617), a double-blind, placebo-controlled trial of one year of testosterone therapy in men ≥65 years with clinical manifestations of androgen deficiency and unequivocally low serum testosterone concentrations (<275 ng/dL). CCTA performed at baseline and after 12 months of therapy will determine testosterone effects on the progression of total volume of non-calcified plaque. All scans are evaluated at a central reading center by an investigator blinded to treatment assignment. Results One hundred sixty-five men were enrolled. The average age is 71.1 years and average BMI 30.7. About 9% of men had a history of myocardial infarction, 6% angina, and 10% coronary artery revascularization. A majority reported hypertension and/or high cholesterol; 31.8% reported diabetes. Total non-calcified plaque at baseline showed a slight but non-significant trend of lower plaque volume with higher serum testosterone concentrations (p=0.12). Conclusions The Cardiovascular Trial will test the hypothesis that testosterone therapy inhibits coronary plaque progression as assessed by serial CCTA.

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Recruitment and Screening for the Testosterone Trials

Abstract: Despite the telephone screening to enrollment ratio of 65 to 1, we met the recruitment goals for each trial. Recruitment of symptomatic older men with low testosterone levels is difficult but feasible.

Cited by 28 publications

References 15 publications

Effects of Testosterone Treatment in Older Men

Effects of Testosterone Treatment in Older Men

Battle of the sex steroids in the male skeleton: and the winner is…

The Cardiovascular Trial of the Testosterone Trials

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