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NCT03747003 Clinical Trial

Gonadal Function in Young to Middle Aged HIV-infected Men

Erectile Dysfunction Clinical Trial

Official title:
Gonadal Function in Young to Middle Aged HIV-infected Men Assessed by Isotopic Dilution-liquid Chromatography-mass Spectrometry (ID-LC-MS/MS) and Chemiluminescent Immunoassay

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03747003
Other study ID # 15/13
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2013
Est. completion date December 31, 2018

Study information
Verified date February 2021
Source Azienda Ospedaliero-Universitaria di Modena
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

HIV infection is associated to premature decline of serum testosterone. However, prevalence and biochemical characterization of hypogonadism in HIV-infected men are still to be well defined. HIV-infection is strongly associated to erectile dysfunction in men, but preliminary data suggest that it is poorly associated with serum testosterone in this context.

Description:

The aim of this study is to evaluate the gonadal function of young to middle aged HIV-infected men in order to characterize hypogonadism by assessing circulating total testosterone with either Liquid Chromatography tandem Mass Spectrometry (LC-MS/MS) or chemiluminescent immunoassay. Furthermore, secondary aim is to assess the erectile function through the use of validated questionnaires (International Index of Erectile Function (IIEF) 15 and 5).

Recruitment information / eligibility
Status Completed
Enrollment 315
Est. completion date December 31, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Male gender - Age 18-50 years - HIV-infection - Ongoing Highly Active Antiretroviral Therapy Exclusion Criteria: - Previous treatment with androgens, anti-androgens - Severe liver insufficiency - Severe renal insufficiency

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention is provided
No intervention is provided

Locations
Country Name City State
Italy Azienda Ospedaliero - Universitaria di Modena Modena

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliero-Universitaria di Modena

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum total testosterone From blood sample - unit of measurement ng/dL Assessed only once at the moment of enrollment with liquid chromatography tandem mass spectrometry
Primary Serum total testosterone From blood sample - unit of measurement ng/dL Assessed only once at the moment of enrollment with chemiluminiscent immunoassay
Secondary Serum free testosterone Calculated formula (Vermeulen equation) Calculated only once at the moment of enrollment
Secondary Score at IIEF questionnaire Total score at erectile function domain of IIEF-15 questionnaire Assessed only once at the moment of enrollment
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