Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Estrogen Receptor Modulators; Estrogens; Selective Estrogen Receptor Modulators; Zuclomiphene

Criteria

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