HypogonadismNCT02434562
Development and Validation of in Vitro Cell-based Bioassays for Nuclear Receptor Activation
An observational study of Hypogonadism and Estrogens, run by Universitaire Ziekenhuizen KU Leuven.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism, Estrogens, Testosterone
- What is being tested?
- Serum (with or without urine) samples
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to 30 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients in the department of Endocrinology/Andrology, Urology and Oncology
Who may be able to join
- Known or expected medical condition affecting androgens, estrogens or SHBG
Who cannot join
- 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
About this study
Official title: Development and Validation of in Vitro Cell-based Bioassays for Nuclear Receptor Activation by Human Serum
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.
Read the detailed description
In vitro cell-based bioassays may be a technique to measure serum androgen or estrogen bioactivity. In this study investigators are collecting serum (and if possible, urine) samples from different cohorts of patients, before and/or after treatment.
The aim is to measure androgens, estrogens and SHBG as well as in vitro bioactivity with newly developed cell-based bioassays, and to compare different techniques to each other as well as to clinical endpoints available in the patient's Electronic Health Record.
- Conditions
- Hypogonadism, Estrogens, Testosterone, Androgens
- Being tested
- Serum (with or without urine) samples
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum (with or without urine) samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Medical castration | Patients treated with androgen deprivation therapy (e.g. for hypersexuality, transgender subjects, ...) Receives: Other: Serum (with or without urine) samples | |
| Male hypogonadism | Patients treated with testosterone replacement therapy (e.g. for late-onset hypogonadism, secondary hypogonadism) Receives: Other: Serum (with or without urine) samples | |
| Thyroid disorders | Patients treated for hyperthyroidism or hypothyroidism (incl. during treatment for thyroid cancer) Receives: Other: Serum (with or without urine) samples | |
| Obesity and weight loss | Patients treated for obesity with weight loss interventions (mainly bariatric surgery) Receives: Other: Serum (with or without urine) samples | |
| Miscellaneous | Various disorders associated with alterations in SHBG, androgens and/or estrogens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosterone bioequivalents (in nanomolar)
Measured: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Estradiol bioequivalents (in picomolar)
Measured: 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)
Measured: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Calculated free and bioavailable estradiol (in picomolar)
Measured: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Total serum testosterone (in nanomolar)
Measured by immunoassay or liquid chromatography tandem mass spectrometry (LC-MS/MS)
Measured: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Total serum estradiol (in picomolar)
Measured by immunoassay or LC-MS/MS
Measured: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Total serum SHBG (in nanomolar)
Measured by immunoassay
Measured: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startApr 2012
- Primary completionSep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk Vanderschueren, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434562
- Sponsor's protocol ID
- s54034
- Status last verified
- May 2016
- First submitted
- 30 Apr 2015
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27576188
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of in Vitro Cell-based Bioassays for Nuclear Receptor Activation by Human Serum
- ClinicalTrials.gov ID
- NCT02434562
- Acronym / sponsor ID
- s54034
- Conditions
- Hypogonadism, Estrogens, Testosterone, Androgens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 5 May 2015 (estimated)
- 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.
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.
Detailed description
In vitro cell-based bioassays may be a technique to measure serum androgen or estrogen bioactivity. In this study investigators are collecting serum (and if possible, urine) samples from different cohorts of patients, before and/or after treatment.
The aim is to measure androgens, estrogens and SHBG as well as in vitro bioactivity with newly developed cell-based bioassays, and to compare different techniques to each other as well as to clinical endpoints available in the patient's Electronic Health Record.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Medical castration | – | Other: Serum (with or without urine) samplesPatients treated with androgen deprivation therapy (e.g. for hypersexuality, transgender subjects, ...) |
| Male hypogonadism | – | Other: Serum (with or without urine) samplesPatients treated with testosterone replacement therapy (e.g. for late-onset hypogonadism, secondary hypogonadism) |
| Thyroid disorders | – | Other: Serum (with or without urine) samplesPatients treated for hyperthyroidism or hypothyroidism (incl. during treatment for thyroid cancer) |
| Obesity and weight loss | – | Other: Serum (with or without urine) samplesPatients treated for obesity with weight loss interventions (mainly bariatric surgery) |
| Miscellaneous | – | –Various disorders associated with alterations in SHBG, androgens and/or estrogens |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in the department of Endocrinology/Andrology, Urology and Oncology
Key inclusion criteria (1 listed)
- Known or expected medical condition affecting androgens, estrogens or SHBG
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Serum (with or without urine) samples | Other | Male hypogonadism, Medical castration, Obesity and weight loss, Thyroid disorders |
Primary outcome
Testosterone bioequivalents (in nanomolar)
Time frame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Estradiol bioequivalents (in picomolar)
Time frame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
5 secondary outcomes
Calculated free and bioavailable testosterone (in nanomolar)
Time frame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Calculated free and bioavailable estradiol (in picomolar)
Time frame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Total serum testosterone (in nanomolar)
Time frame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Total serum estradiol (in picomolar)
Time frame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Total serum SHBG (in nanomolar)
Time frame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Results publication: PubMed 27576188Laurent 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.
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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. This study is not recruiting at the moment.
Dirk Vanderschueren, MD, PhD principal investigator
UZ Leuven
Questions about this trial
What is this clinical trial studying?
An observational study of Hypogonadism and Estrogens, run by Universitaire Ziekenhuizen KU Leuven.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testosterone bioequivalents (in nanomolar) (time frame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)). 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?
On the ClinicalTrials.gov record for NCT02434562, which also lists 1 linked publication.
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 25 Jan 2017; AzTrials last refreshed its copy on 31 Oct 2026.