NCT02434562

Brief Summary

This is a prospective biobank set up to collect serum from patients with disorders associated with changes in androgens, estrogens or sex hormone-binding globulin (SHBG), before and/or after treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Status
completed

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 Start

First participant enrolled

April 1, 2012

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
Last Updated

January 25, 2017

Status Verified

May 1, 2016

Enrollment Period

4.4 years

First QC Date

April 30, 2015

Last Update Submit

January 23, 2017

Conditions

HypogonadismEstrogensTestosteroneAndrogens

Outcome Measures

Primary Outcomes (2)

  • Testosterone bioequivalents (in nanomolar)

    second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)

  • Estradiol bioequivalents (in picomolar)

    second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)

Secondary Outcomes (5)

  • Calculated free and bioavailable testosterone (in nanomolar)

    second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)

  • Calculated free and bioavailable estradiol (in picomolar)

    second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)

  • Total serum testosterone (in nanomolar)

    second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)

  • Total serum estradiol (in picomolar)

    second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)

  • Total serum SHBG (in nanomolar)

    second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)

Study Arms (5)

Medical castration

Patients treated with androgen deprivation therapy (e.g. for hypersexuality, transgender subjects, ...)

Other: Serum (with or without urine) samples

Male hypogonadism

Patients treated with testosterone replacement therapy (e.g. for late-onset hypogonadism, secondary hypogonadism)

Other: Serum (with or without urine) samples

Thyroid disorders

Patients treated for hyperthyroidism or hypothyroidism (incl. during treatment for thyroid cancer)

Other: Serum (with or without urine) samples

Obesity and weight loss

Patients treated for obesity with weight loss interventions (mainly bariatric surgery)

Other: Serum (with or without urine) samples

Miscellaneous

Various disorders associated with alterations in SHBG, androgens and/or estrogens

Interventions

Serum (with or without urine) samplesOTHER
Male hypogonadismMedical castrationObesity and weight lossThyroid disorders

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in the department of Endocrinology/Andrology, Urology and Oncology

You may qualify if:

  • Known or expected medical condition affecting androgens, estrogens or SHBG

You may not qualify if:

  • Inability to provide written informed consent
  • Known or suspected bloodborne infectious diseases (e.g. HIV, viral hepatitis etc.)
  • Anemia (\<11 g/dL hemoglobin) or being a Jehovah's Witness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Laurent MR, Helsen C, Antonio L, Schollaert D, Joniau S, Vos MJ, Decallonne B, Hammond GL, Vanderschueren D, Claessens F. Effects of sex hormone-binding globulin (SHBG) on androgen bioactivity in vitro. Mol Cell Endocrinol. 2016 Dec 5;437:280-291. doi: 10.1016/j.mce.2016.08.041. Epub 2016 Aug 26.

    PMID: 27576188RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum and urine

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Officials

  • Dirk Vanderschueren, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 5, 2015

Study Start

April 1, 2012

Primary Completion

September 1, 2016

Study Completion

September 30, 2016

Last Updated

January 25, 2017

Record last verified: 2016-05