Presentation Authors: Joseph Mahon*, MAYWOOD, IL, Sevann Helo, Minneapolis, MN, Joseph Ellen, Richmond, VA, Paul Fuestel, Charles Welliver, Albany, NY, Andrew McCullough, Burlington, MA
Introduction: The use of selective estrogen receptor modifiers (SERM) and aromatase inhibitors (AI) have been used for decades for the treatment of secondary hypogonadism. While both have been shown to satisfactorily increase free and total testosterone (FT, TT) levels, the clinical benefit on sexual function is unclear. Minimal quality evidence is available for testosterone restoration, particularly with the utilization of validated questionnaires.
Methods: Individuals with baseline TT 150-350 ng/DL on two hormone assays aged 18-70 yrs, positive baseline ADAM score, BMI < 40 and SHIM >7 and < 21 were eligible to be randomized to AI, SERM or placebo for 8 weeks in a cross-over fashion for a total study duration of 24 weeks._x000D_
Hormone assays (TT, FT, LH, FSH, and SHBG) and questionnaire data (ADAM, IIEF, EHS) were collected at baseline and at the conclusion of each 8 week study arm._x000D_
The primary outcome was an improvement of +4 in the erectile function domain of IIEF response after 8 weeks of treatment compared to placebo. Secondary outcomes included: normalization of TT, decreased affirmative responses to ADAM, and improved EHS.
Results: The average age was 45.8 years (range 29-63). Drug agents improved TT to a eugonadal range with SERM reaching higher mean levels than AI +124.1 (95% CI 24.0, 224.1), p=0.01. _x000D_
While a trend towards improvement in ADAM response and the overall satisfaction domain of IIEF were noted for SERM vs. screening; no statistically significant changes in EHS or the other IIEF domains were noted with either drug versus placebo.
Conclusions: In this pilot placebo RCT, both SERM and AI were noted to produce eugonadal levels of TT. Interestingly, however, these improvements did not lead to significant improvements in IIEF domains, ADAM response or EHS validated questionnaire responses. Thus concluding, hypogonadism is far more than just a number.