Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism

NCT02380755 | Completed Phase 2

• 2 other identifiers: 385.6152013/16781-1
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Endothelial Function

  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

  electrochemical luminescence analysis in blood sample

  baseline up to 12 weeks

Study Arms (2)

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

Clomiphene Citrate DRUG

50 mg orally daily during 12 weeks

Also known as: Serophene

Clomiphene Citrate

Placebo DRUG

1 pill orally daily during 12 weeks

Also known as: Control

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Prédio dos ambulatórios HCFMUSP - PAMB

São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Obesity; Endocrine System Diseases; Infertility, Male

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: randomized, double blinded, placebo-controlled, parallel group, single-center study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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).

Study Record Dates

• First Submitted: March 1, 2015
• First Posted: March 5, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: December 27, 2017

Record last verified: 2017-12

Locations

BR (1)