Erectile Dysfunction, Human Immunodeficiency Virus, Hypogonadism, Male
Conditions
Brief 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).
Interventions
No intervention is provided
Sponsors
Azienda Ospedaliero-Universitaria di Modena
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum total testosterone | Assessed only once at the moment of enrollment with liquid chromatography tandem mass spectrometry | From blood sample - unit of measurement ng/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum free testosterone | Calculated only once at the moment of enrollment | Calculated formula (Vermeulen equation) |
| Score at IIEF questionnaire | Assessed only once at the moment of enrollment | Total score at erectile function domain of IIEF-15 questionnaire |
Countries
Italy
Outcome results
None listed