NCT04760574

Brief Summary

Cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Feb 2021Nov 2030

Study Start

First participant enrolled

February 2, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2030

Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

9.8 years

First QC Date

February 16, 2021

Last Update Submit

March 1, 2021

Conditions

Hypogonadism; Ovarian

Outcome Measures

Primary Outcomes (2)

  • 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

    2021-2030

  • Serum free testosterone

    We use serum free testosterone to study the prevalence of hypogonadism in HIV-infected MSM population

    2021-2030

Study Arms (2)

Case group

HIV infected men who have sex with men

Diagnostic Test: Testosterone

Control group

HIV non-infected men

Diagnostic Test: Testosterone

Interventions

TestosteroneDIAGNOSTIC_TEST

Serum total testosterone and free testosterone level

Case groupControl group

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • HIV-infected men who have sex with men
  • HIV non-infected men

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Central Study Contacts

Shyang-Rong Shih, Ph.D.

CONTACT

+886-2-2312-3456srshih@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 18, 2021

Study Start

February 2, 2021

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2030

Last Updated

March 3, 2021

Record last verified: 2021-02

Locations

TW(1)