Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380755
• Other study ID #: 385.615
• Secondary ID: 2013/16781-1
• Status: Completed
• Phase: Phase 2
• First received: March 1, 2015
• Last updated: December 23, 2017
• Start date: April 2015
• Est. completion date: January 2017

Study information

• Verified date: December 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoandrogenism
• Hypogonadism
• Obesity

Intervention

Drug:
• Clomiphene Citrate
50 mg orally daily during 12 weeks
• Placebo
1 pill orally daily during 12 weeks

Locations

Country	Name	City	State
Brazil	Prédio dos ambulatórios HCFMUSP - PAMB	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Function	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.; Icam, vcam and selectin; Endothelial progenitor cels	baseline up to 12 weeks
Primary	Total Testosterone	electrochemical luminescence analysis in blood sample	baseline up to 12 weeks