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Trial record 5 of 51 for:    "Hypogonadism" | "Estrogens"

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

Tracking Information
First Submitted Date  ICMJE March 1, 2015
First Posted Date  ICMJE March 5, 2015
Last Update Posted Date December 27, 2017
Study Start Date  ICMJE April 2015
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2015)
  • 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
  • Total Testosterone [ Time Frame: baseline up to 12 weeks ]
    electrochemical luminescence analysis in blood sample
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02380755 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism
Official Title  ICMJE Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism: Metabolic and Cardiovascular Effects.
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Obesity
  • Hypoandrogenism
Intervention  ICMJE
  • Drug: Clomiphene Citrate
    50 mg orally daily during 12 weeks
    Other Name: Serophene
  • Drug: Placebo
    1 pill orally daily during 12 weeks
    Other Name: Control
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    One pill every other day during 12 weeks
    Intervention: Drug: Placebo
  • Active Comparator: Clomiphene Citrate
    Clomiphene citrate 50 mg orally daily (Serophene) during 12 weeks
    Intervention: Drug: Clomiphene Citrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2015)
78
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02380755
Other Study ID Numbers  ICMJE 385.615
2013/16781-1 ( Other Identifier: FAPESP )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cintia Cercato, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
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
PRS Account University of Sao Paulo
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP