SteroidogenesisNCT02788136
Human Chorionic Gonadotropin Stimulation Effects on Steroidogenesis in Men With Klinefelter Syndrome
A study testing human chorionic gonadotropin in people with Steroidogenesis and Klinefelter Syndrome, run by Azienda USL Modena at 1 site in Italy.
Trial summary
The study design included six visits. During the first visit (visit 0), the subjects underwent physical examination(height, weight, body mass index (BMI), arm span, and upper segment measurement) and testicular ultrasound (US) for the calculation of testicular volume. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Steroidogenesis, Klinefelter Syndrome, Human Chorionic Gonadotropin (hCG) Stimulation
- What is being tested?
- human chorionic gonadotropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2012to Jul 2014
- Phase
- Interventional
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Klinefelter syndrome diagnosis at kariotype evaluation for the study group
- Healthy age-matched men in the control group
Who cannot join
- previous or ongoing androgen therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analisi Del Profilo Sierico Steroideo Basale e Dopo Stimolo Con Gonadotropina Corionica Umana (HCG) Nei Soggetti Affetti da Sindrome di Klinefelter (SK).
The study design included six visits. During the first visit (visit 0), the subjects underwent physical examination(height, weight, body mass index (BMI), arm span, and upper segment measurement) and testicular ultrasound (US) for the calculation of testicular volume. At 0800 h of day 0, all subjects provided a basal blood sample immediately followed by a single intramuscular injection of hCG of 5000 IU. Further five visits were performed each of five following consecutive days after the hCG injection. A blood sample was taken at each visit after an overnight fast
Read the detailed description
Blood samples were centrifuged at 2955 g for 15 min. Sera were transferred into plain polypropylene tubes and stored at -20°C until assayed. P, 17OHP, AS, DHEA, and TS were determined by LC-MS/MS at the laboratory of the Centre for Applied Biomedical Research of the S. Orsola-Malpighi Hospital, Alma Mater Studiorum, University of Bologna, Bologna, Italy.
- Being tested
- human chorionic gonadotropin
- Medical subject headings
- Klinefelter Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human chorionic gonadotropinDrug
Also called hCG
At 08 AM of day 0, all subjects underwent to a single intramuscular injection of hCG of 5000 IU
| Study group | Role | What they receive |
|---|---|---|
| Klinefelter syndrome | Experimental | 13 men with diagnosis of Klinefelter syndrome were stimulated with human chorionic gonadotropin (hCG) Receives: Drug: human chorionic gonadotropin |
| Control | Active comparator | 12 healthy age-related men were stimulated with human chorionic gonadotropin (hCG) Receives: Drug: human chorionic gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosterone
Using mass spectrometry
Measured: visit 1 (Day 1)
Secondary outcomes (7)
Testicular volume
testicular volume at ultrasonography
Measured: visit 0 (Baseline)
Steroids
Steroidogenesis evaluated through mass spectrometry
Measured: Visit 0 (Baseline)
Steroids
Steroidogenesis evaluated through mass spectrometry
Measured: Visit 1 (Day 1)
Steroids
Steroidogenesis evaluated through mass spectrometry
Measured: Visit 2 (Day 2)
Steroids
Steroidogenesis evaluated through mass spectrometry
Measured: Visit 3 (Day 3)
Steroids
Steroidogenesis evaluated through mass spectrometry
Measured: Visit 4 (Day 4)
Steroids
Steroidogenesis evaluated through mass spectrometry
Measured: Visit 5 (Day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startFeb 2012
- Primary completionJul 2014
- Study completionJul 2014
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 SteroidogenesisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuela Simoni, Azienda USL Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788136
- Sponsor's protocol ID
- Klinefelter & hCG
- Status last verified
- Jun 2016
- First submitted
- 30 May 2016
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Belli S, Santi D, Leoni E, Dall'Olio E, Fanelli F, Mezzullo M, Pelusi C, Roli L, Tagliavini S, Trenti T, Granata AR, Pagotto U, Pasquali R, Rochira V, Carani C, Simoni M. Human chorionic gonadotropin stimulation gives evidence of differences in testicular steroidogenesis in Klinefelter syndrome, as assessed by liquid chromatography-tandem mass spectrometry. Eur J Endocrinol. 2016 Jun;174(6):801-11. doi: 10.1530/EJE-15-1224.
PubMed 27188454
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analisi Del Profilo Sierico Steroideo Basale e Dopo Stimolo Con Gonadotropina Corionica Umana (HCG) Nei Soggetti Affetti da Sindrome di Klinefelter (SK).
- ClinicalTrials.gov ID
- NCT02788136
- Acronym / sponsor ID
- Klinefelter & hCG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Azienda USL ModenaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 Jun 2016 (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.
The study design included six visits. During the first visit (visit 0), the subjects underwent physical examination(height, weight, body mass index (BMI), arm span, and upper segment measurement) and testicular ultrasound (US) for the calculation of testicular volume. At 0800 h of day 0, all subjects provided a basal blood sample immediately followed by a single intramuscular injection of hCG of 5000 IU. Further five visits were performed each of five following consecutive days after the hCG injection. A blood sample was taken at each visit after an overnight fast
Detailed description
Blood samples were centrifuged at 2955 g for 15 min. Sera were transferred into plain polypropylene tubes and stored at -20°C until assayed. P, 17OHP, AS, DHEA, and TS were determined by LC-MS/MS at the laboratory of the Centre for Applied Biomedical Research of the S. Orsola-Malpighi Hospital, Alma Mater Studiorum, University of Bologna, Bologna, Italy.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Klinefelter syndrome | Experimental | Drug: human chorionic gonadotropin13 men with diagnosis of Klinefelter syndrome were stimulated with human chorionic gonadotropin (hCG) |
| Control | Active comparator | Drug: human chorionic gonadotropin12 healthy age-related men were stimulated with human chorionic gonadotropin (hCG) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Klinefelter syndrome diagnosis at kariotype evaluation for the study group
- Healthy age-matched men in the control group
Key exclusion criteria (1 listed)
- previous or ongoing androgen therapy
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 |
|---|---|---|
| human chorionic gonadotropinAlso: hCGAt 08 AM of day 0, all subjects underwent to a single intramuscular injection of hCG of 5000 IU | Drug | Control, Klinefelter syndrome |
Primary outcome
Testosterone
Time frame: visit 1 (Day 1)
Using mass spectrometry
7 secondary outcomes
Testicular volume
Time frame: visit 0 (Baseline)
Steroids
Time frame: Visit 0 (Baseline)
Steroids
Time frame: Visit 1 (Day 1)
Steroids
Time frame: Visit 2 (Day 2)
Steroids
Time frame: Visit 3 (Day 3)
Steroids
Time frame: Visit 4 (Day 4)
Steroids
Time frame: Visit 5 (Day 5)
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 7 Jun 2016.
- Background: PubMed 27188454Belli S, Santi D, Leoni E, Dall'Olio E, Fanelli F, Mezzullo M, Pelusi C, Roli L, Tagliavini S, Trenti T, Granata AR, Pagotto U, Pasquali R, Rochira V, Carani C, Simoni M. Human chorionic gonadotropin stimulation gives evidence of differences in testicular steroidogenesis in Klinefelter syndrome, as assessed by liquid chromatography-tandem mass spectrometry. Eur J Endocrinol. 2016 Jun;174(6):801-11. doi: 10.1530/EJE-15-1224.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human chorionic gonadotropin in people with Steroidogenesis and Klinefelter Syndrome, run by Azienda USL Modena at 1 site in Italy.
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 1 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 7 Jun 2016. 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 Italy. 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?
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 (time frame: visit 1 (Day 1)). 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 NCT02788136, 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 7 Jun 2016.