Trial | NCT02380755  Report issue

Title

Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism
Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism: Metabolic and Cardiovascular Effects.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    clomifene ...

  • Study Participants

    78
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 Started
Apr 30
2015
Primary Completion
Jan 31
2017
Study Completion
Jan 31
2017
Last Update
Dec 27
2017

Drug Clomiphene Citrate

50 mg orally daily during 12 weeks

  • Other names: Serophene

Drug Placebo

1 pill orally daily during 12 weeks

  • Other names: Control

Placebo Placebo Comparator

One pill every other day during 12 weeks

Clomiphene Citrate Active Comparator

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

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
No Results Posted