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Effects of Testosterone and Estradiol Deficiency on Vasomotor Symptoms in Hypogonadal Men.

ABSTRACT: The hormonal basis of vasomotor symptoms (VMS) in hypogonadal men is incompletely understood.To determine the contributions of testosterone and estradiol deficiency to VMS in hypogonadal men.Two randomized trials were conducted sequentially between September 2004 and April 2011. Controls were recruited separately.A single-site academic medical center.Healthy men ages 20-50, with normal serum testosterone levels.Cohort 1 (n = 198, 81% completion) received goserelin acetate every 4 weeks to suppress gonadal steroids and were randomized to placebo or 1.25, 2.5, 5, or 10 g of testosterone gel daily for 16 weeks. Cohort 2 (n = 202, 78% completion) received the same regimen as cohort 1 plus anastrozole to block aromatization of testosterone. Controls (n = 37, 89% completion) received placebos for goserelin acetate and testosterone.Incidence of visits with VMS. This was a preplanned secondary analysis.VMS were reported at 26% of visits in cohort 1, and 35% of visits in cohort 2 (P = .02), demonstrating an effect of estradiol deficiency. When adjacent estradiol level groups in cohort 1 were compared, the largest difference in VMS incidence was observed between the 5-9.9 and 10-14.9 pg/mL groups (38% vs 16%, P < .001). In cohort 2, the 10-g testosterone group differed significantly from placebo (16% vs 43%, P = .048) after adjustment for small differences in estradiol levels, indicating that high testosterone levels may suppress VMS.Estradiol deficiency is the key mediator of VMS in hypogonadal men. At high levels, testosterone may have a suppressive effect.

SUBMITTER: Taylor AP

PROVIDER: S-EPMC5010571 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Effects of Testosterone and Estradiol Deficiency on Vasomotor Symptoms in Hypogonadal Men.

Taylor Alexander P AP Lee Hang H Webb Matthew L ML Joffe Hadine H Finkelstein Joel S JS

The Journal of clinical endocrinology and metabolism 20160614 9

<h4>Context</h4>The hormonal basis of vasomotor symptoms (VMS) in hypogonadal men is incompletely understood.<h4>Objective</h4>To determine the contributions of testosterone and estradiol deficiency to VMS in hypogonadal men.<h4>Design</h4>Two randomized trials were conducted sequentially between September 2004 and April 2011. Controls were recruited separately.<h4>Setting</h4>A single-site academic medical center.<h4>Participants</h4>Healthy men ages 20-50, with normal serum testosterone levels ...[more]

PMID: 27300575

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Project description:ObjectiveTo assess the relative effects of individual testosterone products among hypogonadal men.DesignSystematic review and network meta-analysis.MethodsWe searched MEDLINE, Embase, Cochrane CENTRAL, and grey literature (25 May 2017) for randomised-controlled trials (RCTs) and non-randomised studies (NRS) that involved hypogonadal men given testosterone replacement therapy (TRT) for ≥3 months. Comparators were placebo, another TRT, or the same product at a different dose. Outcomes were quality of life, depression, libido, erectile function, activities of daily living and testosterone levels, as well as cardiovascular death, myocardial infarction, stroke, prostate cancer, heart disease, diabetes, serious adverse events, withdrawals due to adverse events and erythrocytosis. RCT data were pooled via meta-analysis and network meta-analysis. Risk of bias was assessed using Cochrane's risk of bias tool (RCTs) andScottish Intercollegiate Guidelines Network (SIGN)50 (NRS).ResultsEighty-seven RCTs and 51 NRS were included. Most were at high or unclear risk of bias, with short treatment duration and follow-up. When compared as a class against placebo, TRT improved quality of life (standardised mean difference (SMD) -0.26, 95% CI -0.41 to -0.11), libido (SMD 0.33, 95% CI 0.16 to 0.50), depression (SMD -0.23, 95% CI -0.44 to -0.01) and erectile function (SMD 0.25, 95% CI 0.10 to 0.41). Most individual TRTs were significantly better than placebo at improving libido (6/10). Only one TRT was better than placebo at improving quality of life, and no individual TRTs improved depression or erectile function. There was no increased risk of adverse events, with the exception of withdrawals due to adverse events with the use of some TRTs.ConclusionDespite a class effect of improving quality of life, depression, erectile function and libido, major improvements were not observed with the use of any individual product. We observed no statistically significant increase in the risk of adverse events; however, longer-term high-quality trials are needed to fully assess the risk of harm.Prospero registration numberCRD42014009963.

Dataset Information

Effects of Testosterone and Estradiol Deficiency on Vasomotor Symptoms in Hypogonadal Men.

Publications

Effects of Testosterone and Estradiol Deficiency on Vasomotor Symptoms in Hypogonadal Men.

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