Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism

University of Sao Paulo78 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Obesity Hypoandrogenism

Interventions

Clomiphene CitrateDRUG

50 mg orally daily during 12 weeks

PlaceboDRUG

1 pill orally daily during 12 weeks

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Prédio dos ambulatórios HCFMUSP - PAMB

São Paulo, Brazil

Outcomes

Primary Outcomes

Endothelial Function

1. Flow-mediated dilatation of the brachial artery (FMDAB): Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter. 2. Icam, vcam and selectin 3. Endothelial progenitor cels

Time frame: baseline up to 12 weeks

Total Testosterone

electrochemical luminescence analysis in blood sample

Time frame: baseline up to 12 weeks

Data from ClinicalTrials.gov

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