NCT03747003

Gonadal Function in Young to Middle Aged HIV-infected Men

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 315 (actual)
• Sponsor: Azienda Ospedaliero-Universitaria di Modena · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Human Immunodeficiency Virus
• Hypogonadism, Male
• Erectile Dysfunction

Interventions

Type	Name	Description
OTHER	No intervention is provided	No intervention is provided

Timeline

• Start date: 2013-05-15
• Primary completion: 2017-12-31
• Completion: 2018-12-31
• First posted: 2018-11-20
• Last updated: 2021-02-09

Locations

1 site across 1 country: Italy