Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism

December 23, 2017 updated by: Cintia Cercato, University of Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • Prédio dos ambulatórios HCFMUSP - PAMB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
One pill every other day during 12 weeks
Drug: Placebo
1 pill orally daily during 12 weeks
Other Names:
  • 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 Names:
  • Serophene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline up to 12 weeks
Total Testosterone
Time Frame: baseline up to 12 weeks
electrochemical luminescence analysis in blood sample
baseline up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Cintia Cercato, MD, Hospital Das Clinicas Da Faculdade De Medicina Da USP
  • Principal Investigator: Elaine Maria F Costa, Prof, PhD, FACULDADE DE MEDICINA DA USP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

March 1, 2015

First Submitted That Met QC Criteria

March 1, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Actual)

December 27, 2017

Last Update Submitted That Met QC Criteria

December 23, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 385.615
  • 2013/16781-1 (Other Identifier: FAPESP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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