Clomiphene Citrate for the Treatment of Obesity Related M... | NCT02380755

Studies
Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism

NCT02380755

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Dec 27, 2017Actual

Enrollment

78Actual

Phase

Phase 2

Conditions

Obesity
Hypoandrogenism

Interventions

Clomiphene Citrate
Placebo

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013/16781-1	Other Identifier	FAPESP

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2017Actual

First Submitted Date

Mar 1, 2015

First Submission Date that Met QC Criteria

Mar 1, 2015

First Posted Date

Mar 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2017

Last Update Posted Date

Dec 27, 2017Actual

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

Obesity
Hypoandrogenism

Keywords

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	One pill every other day during 12 weeks	Drug: Placebo
Clomiphene Citrate	Active Comparator	Clomiphene citrate 50 mg orally daily (Serophene) during 12 weeks	Drug: Clomiphene Citrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clomiphene Citrate	Drug	50 mg orally daily during 12 weeks	Clomiphene Citrate

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cintia Cercato, MD	University of Sao Paulo	Principal Investigator
Elaine Maria F Costa, Prof, PhD	Faculdade de Medicina da USP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prédio dos ambulatórios HCFMUSP - PAMB		São Paulo		05403-000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D004700	Endocrine System Diseases
D007248	Infertility, Male

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002996	Clomiphene

Ancestor Terms

ID	Term
D013267	Stilbenes
D001597	Benzylidene Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided

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).