The Cardiovascular Trial of the Testosterone Trials

Abstract

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.

Testosterone Treatment and Coronary Artery Plaque Volume in Older Men With Low Testosterone

“…The overall study design of the TTrials 14 as well as the design of the Cardiovascular Trial 15 have been published. To qualify for the TTrials overall, a participant had to qualify for at least 1 of the 3 main trials (Sexual Function Trial, Physical Function Trial, and Vitality Trial).…”

“…Each of these sites had at least a 64-slice CCTA scanner and staff experienced in CCTA, as determined by a questionnaire. 15 Precontrast scans for evaluation of coronary artery calcium density and post contrast scans for evaluation of coronary artery plaque volume were performed at baseline and 12 months. If a participant who had a baseline scan developed an allergy to contrast medium or experienced a decrease in estimated glomerular filtration rate to 60 mL/min/1.73 m 2 or less before the month 12 scan, only the precontrast scan was performed at month 12.…”

“…Coronary artery plaque volume was assessed by CCTA at 9 of the 12 TTrials clinical sites. Each of these sites had at least a 64-slice CCTA scanner and staff experienced in CCTA, as determined by a questionnaire . Precontrast scans for evaluation of coronary artery calcium density and postcontrast scans for evaluation of coronary artery plaque volume were performed at baseline and 12 months.…”

Basal Anti Mullerian hormone levels and endometrial thickness at midcycle can predict the outcome after clomiphene citrate stimulation in anovulatory women with PCOS, a retrospective study

“…The diagnosis was made in the event that two out of the three criteria were fulfilled: oligo/anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries. All women revealed ≥ 12 follicles of 2–9 mm diameter on at least one ovary on transvaginal ultrasound, as well as 17-hydroxy progesterone levels < 2 ng/mL, and, thus, non-classical adrenogenital syndrome could be excluded [25].…”

Antimüllerian hormone and endometrial thickness in predicting xfollicular maturation in patients with polycystic ovary syndrome

“…Before CC treatment, 95.4% of patients had an EMT of ≤5 mm and a follicular size of 1 to 6 mm, similar to the finding in Abd Alamir et al's study. 13 CC treatment had resulted in a midcycle EMT of 6 to 10 mm in approximately 74.6% of participants. This agrees with the results reported in Gaba et al's study.…”