Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism

Hypogonadism (low testosterone level) in obese man is a clinical condition which treatment is controversial. Most of this controversy remains regarding the association between cardiovascular risk elevation and Testosterone replacement therapy in some studies.

This protocol is a double blinded randomized placebo trial and 2 groups will be followed. The primary end-point of this research is the correlation between the serum testosterone and flow-mediated dilatation of the brachial artery (FMDAB), circulating levels of sICAM-1, sVCAM-1, E-selectin and progenitor endothelial cells.

The secondary end-points include:

(1) the evaluation of metabolic parameters: weight, abdominal circumference, glycaemia, total cholesterol, fractions and triglycerides, homeostasis model assessment index (HOMA) and bioelectrical impedance parameters; and (2) hormonal parameters: total testosterone levels, sex hormone-binding globulin (SHBG), Luteinizing Hormone (LH) , Follicle stimulating hormone (FSH) and Estradiol.

Inclusion criteria

• ADAM questionnaire positive for 3 or more questions
• Total serum Testosterone lower than 300 ng/dL in two different occasions, within a 1-week minimum interval. This blood sample must be collected between 8 and 11 a.m.
• Low or Inappropriate normal serum Luteinizing hormone (LH) level
• ATP III Metabolic Syndrome Criteria
• Obesity - BMI over 30 kg/m2

Exclusion criteria

• Systemic illness, such Rheumatoid Arthritis, Cushing disease, liver insufficiency or renal insufficiency. -Use of certain medications (opiates, high-dose glucocorticoid therapy, methadone)
• Eating disorders
• Testicular volume below 4 mL
• Use of recreational drugs
• Excessive exercise practice
• Men in treatment for prostatic cancer
• Hyperprolactinaemia
• Hemochromatosis
• History of headache
• Systolic blood pressure lower than 100 mmHg
• Previous adverse reactions to nitrate compounds
• Diabetes over 10 years of diagnosis