Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism
|ClinicalTrials.gov Identifier: NCT02380755|
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : December 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity Hypoandrogenism||Drug: Clomiphene Citrate Drug: Placebo||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||78 participants|
|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|
|Official Title:||Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism: Metabolic and Cardiovascular Effects.|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Placebo Comparator: Placebo
One pill every other day during 12 weeks
1 pill orally daily during 12 weeks
Other Name: 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 Name: Serophene
- Endothelial Function [ Time Frame: baseline up to 12 weeks ]
- 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
- Total Testosterone [ Time Frame: baseline up to 12 weeks ]electrochemical luminescence analysis in blood sample
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02380755
|Prédio dos ambulatórios HCFMUSP - PAMB|
|Sao Paulo, Brazil, 05403-000|
|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|