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Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism

NCT ID: NCT02380755

Last Updated: 2017-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-01-31

Brief Summary

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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

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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.

Conditions

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Obesity Hypoandrogenism

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
randomized, double blinded, placebo-controlled, parallel group, single-center study

Study Groups

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Placebo

One pill every other day during 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 pill orally daily during 12 weeks

Clomiphene Citrate

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

Group Type ACTIVE_COMPARATOR

Clomiphene Citrate

Intervention Type DRUG

50 mg orally daily during 12 weeks

Interventions

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Clomiphene Citrate

50 mg orally daily during 12 weeks

Intervention Type DRUG

Placebo

1 pill orally daily during 12 weeks

Intervention Type DRUG

Other Intervention Names

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Serophene Control

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Cintia Cercato

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cintia Cercato, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital das Clínicas da Faculdade de Medicina da USP

Elaine Maria F Costa, Prof, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Medicina da USP

Locations

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Prédio dos ambulatórios HCFMUSP - PAMB

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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2013/16781-1

Identifier Type: OTHER

Identifier Source: secondary_id

385.615

Identifier Type: -

Identifier Source: org_study_id