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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Erectile Dysfunction
• HIV Infections
• Human Immunodeficiency Virus
• Hypogonadism
• Hypogonadism, Male

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