Daily Tadalafil on Body Fat and Lean Mass

Study design: open-label, randomized controlled study Study duration: 16 weeks (8 active treatment + 8 follow-up)

At baseline, after 8 and 16 weeks the following evaluations will be assessed: general physical examination and anthropometric parameters i.e., body weight (BW), height, BMI, and waist circumference (WC). Every eight weeks, body composition was calculated by using a whole body dual-energy X-ray absorptiometry (DEXA-HOLOGIC QDR-1000) according to the instructions of the manufacturer and standardized procedures, and the individual Total Fat Mass (FM) variation has been expressed as delta-variation (%) from baseline. Abdominal fat mass (distrectual, described as R1) was calculated by using arbitrary area of the square chosen by tracing of an ideal line joining last inferior ribs and anterior superior iliac spines. Calibration with the manufacturer's spine phantom and quality control analysis were performed daily. Fat Mass was expressed in grams per square centimeter (g/cm2) and result expressed as variation in percentage. Secondary outcomes were variations forom baseline of IIEF-5, total testosterone, estradiol and testosterone /estradiol ratios.

STATISTICAL EVALUATION With a two-sided alpha value of 5% and power of 90%, a sample size of 20 subjects per arm would be able to detect a 2% variation in the percentage of body lean and fat mass from the baseline at upper waist section (for fat mass) and overall body composition (for lean mass). Also, we tested for the differences between treatment groups by using analysis of variance for repeated measures. Statistical analysis was performed by using the computer statistical package SPSS 11.0 (SPSS Inc., Chicago, IL).

Inclusion criteria

• Male subjects greater than 18 years with any BMI who volunteered to enter the study because of the presence of sexual distress and/or mild erectile dysfunction.

Exclusion criteria

• Any concomitant treatment during the prior three months, changes in lifestyle, diet or physical exercise attended within the 16 weeks of study duration; patients actively or potentially trying to start a family or requiring fertility treatment; significant hepatic, respiratory, hematological or renal disease; history of drug or alcohol abuse; history or presence of any cancer; any other reason, which the investigator feels, precludes safe inclusion of the patient.