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ABSTRACT: Context
The hormonal basis of vasomotor symptoms (VMS) in hypogonadal men is incompletely understood.Objective
To determine the contributions of testosterone and estradiol deficiency to VMS in hypogonadal men.Design
Two randomized trials were conducted sequentially between September 2004 and April 2011. Controls were recruited separately.Setting
A single-site academic medical center.Participants
Healthy men ages 20-50, with normal serum testosterone levels.Intervention
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.Main outcome measures
Incidence of visits with VMS. This was a preplanned secondary analysis.Results
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.Conclusions
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
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]