Hypogonadism; OvarianNCT04760574
Association Between Human Immunodeficiency Virus (HIV) Infection and Male Hypogonadism
An observational study of Hypogonadism; Ovarian, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism; Ovarian
- What is being tested?
- Testosterone
- How many people
- 1,200 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Feb 2021to Nov 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population. Age-matched non-HIV infected group will be used as comparison group
Who may be able to join
- HIV-infected men who have sex with men
- HIV non-infected men
Who cannot join
- Use of testosterone supplement, anabolic steroid in the past one year.
- History of pituitary , adrenal or gonad diseases
- History of pituitary surgery or radiation therapy
- History of systemic chemotherapy
- Active opportunistic infection under treatment
- Cancer
- Severe hepatic, renal or cardiac impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Shyang-Rong Shih, Ph.D., +886-2-2312-3456 ext. 61613, srshih@ntu.edu.tw
About this study
Cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population
Read the detailed description
In this study, we conduct a cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population. Age-matched non-HIV infected MSM group will be used as comparison group. We will also determine the risk factors associated with male hypogonadism (age, duration of HIV infection, comorbidities, BMI, ART use). Correlation will be made between serum testosterone levels and sexual function, vitality, exercise capacity, mood, and bone mineral density.
- Conditions
- Hypogonadism; Ovarian
- Being tested
- Testosterone
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDiagnostic test
Serum total testosterone and free testosterone level
| Study group | Role | What they receive |
|---|---|---|
| Case group | HIV infected men who have sex with men Receives: Diagnostic Test: Testosterone | |
| Control group | HIV non-infected men Receives: Diagnostic Test: Testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of androgen deficiency
We use the score of Androgen Deficiency in Aging Males (ADAM) questionnaire to study the prevalence of hypogonadism in HIV-infected MSM population
Measured: 2021-2030
Serum free testosterone
We use serum free testosterone to study the prevalence of hypogonadism in HIV-infected MSM population
Measured: 2021-2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start2 Feb 2021
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadism; OvarianStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760574
- Sponsor's protocol ID
- 202010105RIND
- Status last verified
- Feb 2021
- First submitted
- 16 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Human Immunodeficiency Virus (HIV) Infection and Male Hypogonadism
- ClinicalTrials.gov ID
- NCT04760574
- Acronym / sponsor ID
- 202010105RIND
- Conditions
- Hypogonadism; Ovarian
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population
Detailed description
In this study, we conduct a cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population. Age-matched non-HIV infected MSM group will be used as comparison group. We will also determine the risk factors associated with male hypogonadism (age, duration of HIV infection, comorbidities, BMI, ART use). Correlation will be made between serum testosterone levels and sexual function, vitality, exercise capacity, mood, and bone mineral density.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Diagnostic Test: TestosteroneHIV infected men who have sex with men |
| Control group | – | Diagnostic Test: TestosteroneHIV non-infected men |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population. Age-matched non-HIV infected group will be used as comparison group
Key inclusion criteria (2 listed)
- HIV-infected men who have sex with men
- HIV non-infected men
Key exclusion criteria (7 listed)
- Use of testosterone supplement, anabolic steroid in the past one year.
- History of pituitary , adrenal or gonad diseases
- History of pituitary surgery or radiation therapy
- History of systemic chemotherapy
- Active opportunistic infection under treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TestosteroneSerum total testosterone and free testosterone level | Diagnostic test | Case group, Control group |
Primary outcome
Symptoms of androgen deficiency
Time frame: 2021-2030
We use the score of Androgen Deficiency in Aging Males (ADAM) questionnaire to study the prevalence of hypogonadism in HIV-infected MSM population
Serum free testosterone
Time frame: 2021-2030
We use serum free testosterone to study the prevalence of hypogonadism in HIV-infected MSM population
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypogonadism; Ovarian, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shyang-Rong Shih, Ph.D. (+886-2-2312-3456 ext. 61613, srshih@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of androgen deficiency (time frame: 2021-2030). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.