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Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism

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ClinicalTrials.gov Identifier: NCT02380755
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : December 27, 2017
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Cintia Cercato, University of Sao Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Hypoandrogenism Drug: Clomiphene Citrate Drug: Placebo Phase 2

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 78 patients were randomized (1:1) to receive Clomiphene Citrate (CC) 50 mg during 12 weeks or placebo (PLB). MAIN OUTCOME MEASURES: flow-mediated dilatation of the brachial artery (FMDAB), circulating levels of sICAM-1, sVCAM-1, E-selectin and progenitor endothelial cells. Secondary endpoints: Body mass index (BMI), abdominal circumference (AC), glycaemia, total cholesterol, fractions and triglycerides, HOMA-IR index, bioelectrical impedance parameters, Adam questionnaire and hormonal parameters (total testosterone levels, SHBG, LH, FSH and Estradiol).
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: randomized, double blinded, placebo-controlled, parallel group, single-center study
Primary Purpose: Treatment
Official Title: Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism: Metabolic and Cardiovascular Effects.
Study Start Date : April 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
One pill every other day during 12 weeks
Drug: Placebo
1 pill orally daily during 12 weeks
Other Name: Control

Active Comparator: Clomiphene Citrate
Clomiphene citrate 50 mg orally daily (Serophene) during 12 weeks
Drug: Clomiphene Citrate
50 mg orally daily during 12 weeks
Other Name: Serophene




Primary Outcome Measures :
  1. Endothelial Function [ Time Frame: baseline up to 12 weeks ]
    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

  2. Total Testosterone [ Time Frame: baseline up to 12 weeks ]
    electrochemical luminescence analysis in blood sample



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02380755


Locations
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Brazil
Prédio dos ambulatórios HCFMUSP - PAMB
Sao Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Cintia Cercato, MD Hospital das Clínicas da Faculdade de Medicina da USP
Principal Investigator: Elaine Maria F Costa, Prof, PhD Faculdade de Medicina da USP

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Responsible Party: Cintia Cercato, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02380755     History of Changes
Other Study ID Numbers: 385.615
2013/16781-1 ( Other Identifier: FAPESP )
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Keywords provided by Cintia Cercato, University of Sao Paulo:
Flow-mediated dilatation
Clomiphene citrate
sICAM-1
sVCAM-1
sE- Selectin
Endothelial function
Cardiovascular risk
Endocrine System Diseases
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Infertility, Male
Endothelial Progenitor Cells
Obesity
Testosterone
Additional relevant MeSH terms:
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Obesity
Hypogonadism
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
Estrogens
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents