Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism

University of Sao Paulo

Status and phase: Completed; Phase 2

Conditions: Obesity; Hypoandrogenism

Treatments: Drug: Clomiphene Citrate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02380755

385.615

2013/16781-1 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

One pill every other day during 12 weeks

Treatment:

Drug: Placebo

Clomiphene Citrate

Active Comparator group

Description:

Clomiphene citrate 50 mg orally daily (Serophene) during 12 weeks

Treatment:

Drug: Clomiphene Citrate