Abstract
Introduction: Little is known about the effect of body mass index (BMI) on the efficacy and safety of testosterone therapy in hypogonadal men. A prior noncomparative trial demonstrated that testosterone 2% gel restored testosterone levels in hypogonadal men and was generally well tolerated. Aim: This post hoc analysis evaluated the influence of BMI on the pharmacokinetics of testosterone therapy in men with low testosterone. Methods: Men (N=149) aged 18-75 applied testosterone 2% gel to the front and inner thigh once daily for 90 days. Starting dose was 40mg/day, which could be adjusted at days 14, 35, and 60. Patients were split into categories depending on baseline BMI: Tertile 1 (≤29.1kg/m2), Tertile 2 (29.2-32.4kg/m2), and Tertile 3 (>32.4kg/m2). Main Outcome Measures: Efficacy end points were average serum total testosterone concentrations over 24 hours and maximum serum testosterone concentrations at day 90. Adverse events were recorded. Results: The efficacy analysis included 129 men with low testosterone (mean age 52.9, 54.0, and 54.2 years for Tertiles 1, 2, and 3, respectively) defined as serum testosterone <250-300ng/dL. Baseline testosterone levels were comparable across BMI tertiles. After 90 days of treatment with testosterone 2% gel (≥40mg/day), 79.1%, 79.5%, and 73.8% of patients in Tertiles 1, 2, and 3, respectively, achieved serum testosterone concentrations in the physiologic range (i.e., ≥300 to ≤1,140ng/dL). The mean average daily dose at day 90 was higher in participants in Tertiles 3 vs. 2 (P=0.039) and Tertiles 3 vs. 1 (P=0.010). The gel was generally well tolerated, with skin reactions the most commonly reported adverse event (16.1%; n=24). Conclusions: In this study, daily application of testosterone 2% gel was effective at returning serum testosterone to physiologic levels in men with low testosterone and high BMI, although required dose was affected by BMI.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 857-864 |
| Number of pages | 8 |
| Journal | Journal of Sexual Medicine |
| Volume | 11 |
| Issue number | 3 |
| DOIs | |
| State | Published - Jan 1 2014 |
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Keywords
- Body Mass Index
- Hypogonadism
- Testosterone Replacement
- Transdermal Systemic Testosterone Gel
ASJC Scopus subject areas
- Reproductive Medicine
- Obstetrics and Gynecology
- Urology
Cite this
Testosterone 2% gel can normalize testosterone concentrations in men with low testosterone regardless of body mass index. / Dobs, Adrian S; Norwood, Paul; Potts, Susan; Gould, Errol; Chitra, Surya.
In: Journal of Sexual Medicine, Vol. 11, No. 3, 01.01.2014, p. 857-864.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Testosterone 2% gel can normalize testosterone concentrations in men with low testosterone regardless of body mass index
AU - Dobs, Adrian S
AU - Norwood, Paul
AU - Potts, Susan
AU - Gould, Errol
AU - Chitra, Surya
PY - 2014/1/1
Y1 - 2014/1/1
N2 - Introduction: Little is known about the effect of body mass index (BMI) on the efficacy and safety of testosterone therapy in hypogonadal men. A prior noncomparative trial demonstrated that testosterone 2% gel restored testosterone levels in hypogonadal men and was generally well tolerated. Aim: This post hoc analysis evaluated the influence of BMI on the pharmacokinetics of testosterone therapy in men with low testosterone. Methods: Men (N=149) aged 18-75 applied testosterone 2% gel to the front and inner thigh once daily for 90 days. Starting dose was 40mg/day, which could be adjusted at days 14, 35, and 60. Patients were split into categories depending on baseline BMI: Tertile 1 (≤29.1kg/m2), Tertile 2 (29.2-32.4kg/m2), and Tertile 3 (>32.4kg/m2). Main Outcome Measures: Efficacy end points were average serum total testosterone concentrations over 24 hours and maximum serum testosterone concentrations at day 90. Adverse events were recorded. Results: The efficacy analysis included 129 men with low testosterone (mean age 52.9, 54.0, and 54.2 years for Tertiles 1, 2, and 3, respectively) defined as serum testosterone <250-300ng/dL. Baseline testosterone levels were comparable across BMI tertiles. After 90 days of treatment with testosterone 2% gel (≥40mg/day), 79.1%, 79.5%, and 73.8% of patients in Tertiles 1, 2, and 3, respectively, achieved serum testosterone concentrations in the physiologic range (i.e., ≥300 to ≤1,140ng/dL). The mean average daily dose at day 90 was higher in participants in Tertiles 3 vs. 2 (P=0.039) and Tertiles 3 vs. 1 (P=0.010). The gel was generally well tolerated, with skin reactions the most commonly reported adverse event (16.1%; n=24). Conclusions: In this study, daily application of testosterone 2% gel was effective at returning serum testosterone to physiologic levels in men with low testosterone and high BMI, although required dose was affected by BMI.
AB - Introduction: Little is known about the effect of body mass index (BMI) on the efficacy and safety of testosterone therapy in hypogonadal men. A prior noncomparative trial demonstrated that testosterone 2% gel restored testosterone levels in hypogonadal men and was generally well tolerated. Aim: This post hoc analysis evaluated the influence of BMI on the pharmacokinetics of testosterone therapy in men with low testosterone. Methods: Men (N=149) aged 18-75 applied testosterone 2% gel to the front and inner thigh once daily for 90 days. Starting dose was 40mg/day, which could be adjusted at days 14, 35, and 60. Patients were split into categories depending on baseline BMI: Tertile 1 (≤29.1kg/m2), Tertile 2 (29.2-32.4kg/m2), and Tertile 3 (>32.4kg/m2). Main Outcome Measures: Efficacy end points were average serum total testosterone concentrations over 24 hours and maximum serum testosterone concentrations at day 90. Adverse events were recorded. Results: The efficacy analysis included 129 men with low testosterone (mean age 52.9, 54.0, and 54.2 years for Tertiles 1, 2, and 3, respectively) defined as serum testosterone <250-300ng/dL. Baseline testosterone levels were comparable across BMI tertiles. After 90 days of treatment with testosterone 2% gel (≥40mg/day), 79.1%, 79.5%, and 73.8% of patients in Tertiles 1, 2, and 3, respectively, achieved serum testosterone concentrations in the physiologic range (i.e., ≥300 to ≤1,140ng/dL). The mean average daily dose at day 90 was higher in participants in Tertiles 3 vs. 2 (P=0.039) and Tertiles 3 vs. 1 (P=0.010). The gel was generally well tolerated, with skin reactions the most commonly reported adverse event (16.1%; n=24). Conclusions: In this study, daily application of testosterone 2% gel was effective at returning serum testosterone to physiologic levels in men with low testosterone and high BMI, although required dose was affected by BMI.
KW - Body Mass Index
KW - Hypogonadism
KW - Testosterone Replacement
KW - Transdermal Systemic Testosterone Gel
UR - http://www.scopus.com/inward/record.url?scp=84895448794&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84895448794&partnerID=8YFLogxK
U2 - 10.1111/jsm.12411
DO - 10.1111/jsm.12411
M3 - Article
C2 - 24283410
AN - SCOPUS:84895448794
VL - 11
SP - 857
EP - 864
JO - Journal of Sexual Medicine
JF - Journal of Sexual Medicine
SN - 1743-6095
IS - 3
ER -