Testosterone 2% gel can normalize testosterone concentrations in men with low testosterone regardless of body mass index.
J Sex Med
; 11(3): 857-64, 2014 Mar.
Article
en En
| MEDLINE
| ID: mdl-24283410
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 40 mg/day, which could be adjusted at days 14, 35, and 60. Patients were split into categories depending on baseline BMI Tertile 1 (≤ 29.1 kg/m(2)), Tertile 2 (29.2-32.4 kg/m(2)), and Tertile 3 (>32.4 kg/m(2)). MAIN OUTCOMEMEASURES:
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 <250-300 ng/dL. Baseline testosterone levels were comparable across BMI tertiles. After 90 days of treatment with testosterone 2% gel (≥ 40 mg/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 ≤ 1,140 ng/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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Testosterona
/
Índice de Masa Corporal
/
Hipogonadismo
/
Andrógenos
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
/
Adult
/
Aged
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
J Sex Med
Asunto de la revista:
GINECOLOGIA
/
MEDICINA REPRODUTIVA
/
UROLOGIA
Año:
2014
Tipo del documento:
Article
País de afiliación:
Estados Unidos