title: A comparison of anastrozole and testosterone versus placebo and testosterone for treatment of sexual dysfunction in men with epilepsy and hypogonadism.
abstract: Hyposexuality is commonly associated with low bioavailable testosterone (BAT) and relative estradiol elevation in men with epilepsy. This prospective, randomized, double-blind trial compared the effects of depotestosterone+the aromatase inhibitor anastrozole (T-A) versus depotestosterone+placebo (T-P) on sexual function, hormone levels, mood, and seizure frequency in men with epilepsy. Forty men with focal epilepsy, hyposexuality, and hypogonadism were randomized 1:1 to two groups (T-A or T-P) for a 3-month treatment trial of depotestosterone+either anastrozole or matching placebo. Outcomes included both efficacy and safety measures. Normalization of sexual function (S-score) occurred with greater frequency in the T-A (72.2%) than in the T-P (47.4%) group, but the difference was not statistically significant. T-A resulted in significantly lower estradiol levels and S-scores correlated inversely with estradiol levels at baseline and during treatment. Beck Depression Inventory II (BDI-II) scores improved significantly in both groups and changes in S-score correlated inversely with changes in BDI-II score. Changes in seizure frequency correlated with changes in BDI-II score. Seizure frequency decreased with both treatments and showed significant correlations with estradiol levels. Triglyceride levels increased with T-P and decreased with T-A. The difference in triglyceride changes between the two treatments was significant and correlated with changes in estradiol levels. Significant correlations between estradiol levels and S-scores, as well as seizure outcomes and triglyceride levels, suggest further study regarding a potential role for anastrozole in the treatment of men with epilepsy who have hyposexuality and hypogonadism.
authors.affiliation: Harvard Neuroendocrine Unit, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA. aherzog@bidmc.harvard.edu
authors.forename: Andrew G
authors.initials: AG
authors.lastname: Herzog
authors.forename: Erin L
authors.initials: EL
authors.lastname: Farina
authors.forename: Frank W
authors.initials: FW
authors.lastname: Drislane
authors.forename: Donald L
authors.initials: DL
authors.lastname: Schomer
authors.forename: Sarah D
authors.initials: SD
authors.lastname: Smithson
authors.forename: Kristen M
authors.initials: KM
authors.lastname: Fowler
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Dworetzky
authors.forename: Edward B
authors.initials: EB
authors.lastname: Bromfield
mesh_terms: D000293:Adolescent; D000328:Adult; D000077384:Anastrozole; D047072:Aromatase Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004827:Epilepsy / Q000453:epidemiology*; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy* / Q000453:epidemiology*; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000627:therapeutic use*; D011446:Prospective Studies; D012735:Sexual Dysfunction, Physiological / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D013739:Testosterone / Q000008:administration & dosage / Q000627:therapeutic use*; D014230:Triazoles / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D047072:Aromatase Inhibitors; D009570:Nitriles; D014230:Triazoles; D000077384:Anastrozole; D013739:Testosterone