Testosterone replacement therapy in hypogonadal men: The contribution of endogenous testosterone production

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SAT 281-290-Comparative Effectiveness/Health Outcomes/Quality Improvement/Patient or Provider Education/Endocrine Emergencies
Clinical
Saturday, June 15, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SAT-290
David Muram* and Xiao Ni
Eli Lilly and Company, Indianapolis, IN
Objective: This post-hoc analysis investigated the effects of endogenous testosterone (T) production reflected by baseline testosterone levels on testosterone replacement therapy (TRT) in hypogonadal men.

Design: In this open-label titration trial, 2% T topical solution was applied to the axillae daily for 120 days. Dose adjustments were allowed on Days 45 and 90 to maintain T within physiological range (300 - 1050 ng/dL).

Patients: Males (N = 155) over 18 years of age with hypogonadism (T < 300 ng/dL).

Measurements: Serum T levels were measured at days 15, 60 and 120. Subjects were divided by T-level at baseline (T < 230 ng/dL and T ≥ 230 ng/dL). Changes in T levels and the dose of TRT required to achieve serum T level within (300 - 1050 ng/dL) were collected.

Results: At baseline, 74 and 80 subjects were in the T<230 and T ≥ 230 ng/dL groups respectively (one subject was removed from the analysis due to protocol violation of using TRT prior to baseline). At day 15, patients whose T levels at baseline were <230ng/dL had slightly lower serum T levels (413 vs. 463, p=0.09). Similar results were seen on day 60 (470 vs 486, p=0.66) and day 120 (447 vs. 502, p=0.04). However, a similar proportion of patients in each group reached the threshold of 300ng/dL. Among patients who had a Day 45 visit, numerically higher proportion of patients in the <230 group required dose escalation (22% vs. 17%) based on the Day 15 T level; however, the difference is not statistically significant (p=0.52, based on the Fisher’s exact test).

Conclusions: While baseline T levels may affect the final T concentration, a similar proportion of patients was within the normal range and reach the therapeutic goal. Patients, especially those with very low levels at baseline, may benefit from close monitoring of testosterone levels and appropriate dose adjustment.

Disclosure: DM: Employee, Eli Lilly & Company. XN: Employee, Eli Lilly & Company.

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm

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