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CompletedNCT03747003Updated Feb 9, 2021

Gonadal Function in Young to Middle Aged HIV-infected Men

An observational study in Human Immunodeficiency Virus, Hypogonadism, Male and Erectile Dysfunction, sponsored by Azienda Ospedaliero-Universitaria di Modena. Completed at 1 site in Italy. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-02-09.

Primary conditionEunuchismRegistry: Acquired Immunodeficiency SyndromeReclassifiedWhy we changed it
Registry
Acquired Immunodeficiency Syndrome — the first condition term the registry derived for this study.
ClinicalTrials.gg
Eunuchism
Why
  1. The registry often attaches Acquired Immunodeficiency Syndrome to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Eunuchism.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Azienda Ospedaliero-Universitaria di Modena · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
315
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

Read the 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).

02

Conditions studied

  • Human Immunodeficiency Virus
  • Hypogonadism, Male
  • Erectile Dysfunction

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03

In context

Eunuchism Reclassified

75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.

This study's enrollment of 315 is above the median of 100 across 17 observational studies indexed under Eunuchism.

Browse Eunuchism studies →

Lead sponsor

Azienda Ospedaliero-Universitaria di Modena is the lead sponsor of 48 studies on the registry; 20 are open to participants now.

Compared within Eunuchism, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cohort of Young-to-Middle Aged HIV-infected Patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male gender
  • Age 18-50 years
  • -infection
  • Ongoing Highly Active Antiretroviral Therapy

Exclusion criteria

Exclusion Criteria:

  • Previous treatment with androgens, anti-androgens
  • Severe liver insufficiency
  • Severe renal insufficiency
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
315 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • HIV-infected male patients

    Male patients (age 18-50 years) with HIV-infection and ongoing HAART therapy No intervention is provided

    Other: No intervention is provided

Interventions

  • OtherNo intervention is provided

    No intervention is provided

06

What researchers measure

Primary outcomes

  1. Serum total testosterone

    From blood sample - unit of measurement ng/dL

    Time frame: Assessed only once at the moment of enrollment with liquid chromatography tandem mass spectrometry

  2. Serum total testosterone

    From blood sample - unit of measurement ng/dL

    Time frame: Assessed only once at the moment of enrollment with chemiluminiscent immunoassay

Secondary outcomes

  1. Serum free testosterone

    Calculated formula (Vermeulen equation)

    Time frame: Calculated only once at the moment of enrollment

  2. Score at IIEF questionnaire

    Total score at erectile function domain of IIEF-15 questionnaire

    Time frame: Assessed only once at the moment of enrollment

07

Study locations

1 site
  • Azienda Ospedaliero - Universitaria di Modena
    Modena, 41124, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2013 to primary completion in Dec 2017, 55 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 16, 2018
First posted
Nov 20, 2018
StartActual
May 15, 2013
Primary completionActual
Dec 31, 2017
CompletionActual
Dec 31, 2018
Last update
Feb 9, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03747003
Lead sponsor
Azienda Ospedaliero-Universitaria di Modena
Responsible party
Vincenzo Rochira (Associate Professor, Azienda Ospedaliero-Universitaria di Modena) — Principal investigator
First posted
Nov 20, 2018
Start date
May 15, 2013
Primary completion
Dec 31, 2017
Completion
Dec 31, 2018
Last update
Feb 9, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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