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
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 |
Verified date | February 2021 |
Source | Azienda Ospedaliero-Universitaria di Modena |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero - Universitaria di Modena | Modena |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria di Modena |
Italy,
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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