Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism
Condition: Obesity; Hypoandrogenism
MeSH terms: Obesity; Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypogonadism is a clinical condition that can be associated with obesity in man. Controversy
      exists regarding if its a condition that needs to be treated. The standard Testosterone
      Therapy is associated with increase in cardiovascular risks, according to some studies, and
      leads to infertility. The use of Clomiphene Citrate in this sub population of obese man as an
      alternative treatment option is not well studied. The aim of this protocol is to evaluate the
      cardiovascular risks, metabolic and hormonal parameters in a double blinded randomized
      placebo trial.
    

Detailed description: 
      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.
    

Intervention name(s): Clomiphene Citrate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg orally daily during 12 weeks; 1 pill orally daily during 12 weeks
Other intervention name(s): Serophene; Control
Intervention MeSH terms: Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 78 patients were randomized (1:1) to receive Clomiphene Citrate (CC) 50 mg during 12 weeks or placebo (PLB). MAIN OUTCOME MEASURES: flow-mediated dilatation of the brachial artery (FMDAB), circulating levels of sICAM-1, sVCAM-1, E-selectin and progenitor endothelial cells. Secondary endpoints: Body mass index (BMI), abdominal circumference (AC), glycaemia, total cholesterol, fractions and triglycerides, HOMA-IR index, bioelectrical impedance parameters, Adam questionnaire and hormonal parameters (total testosterone levels, SHBG, LH, FSH and Estradiol).
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Flow-mediated dilatation; Clomiphene citrate; sICAM-1; sVCAM-1; sE- Selectin; Endothelial function; Cardiovascular risk; Endocrine System Diseases; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Infertility, Male; Endothelial Progenitor Cells; Obesity; Testosterone