Human Chorionic Gonadotropin Stimulation Effects on Steroidogenesis in Men With Klinefelter Syndrome
Analisi Del Profilo Sierico Steroideo Basale e Dopo Stimolo Con Gonadotropina Corionica Umana (HCG) Nei Soggetti Affetti da Sindrome di Klinefelter (SK).
1 other identifier
interventional
25
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 30, 2016
CompletedFirst Posted
Study publicly available on registry
June 2, 2016
CompletedJune 7, 2016
June 1, 2016
2.4 years
May 30, 2016
June 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Testosterone
Using mass spectrometry
visit 1 (Day 1)
Secondary Outcomes (7)
Testicular volume
visit 0 (Baseline)
Steroids
Visit 0 (Baseline)
Steroids
Visit 1 (Day 1)
Steroids
Visit 2 (Day 2)
Steroids
Visit 3 (Day 3)
- +2 more secondary outcomes
Study Arms (2)
Klinefelter syndrome
EXPERIMENTAL13 men with diagnosis of Klinefelter syndrome were stimulated with human chorionic gonadotropin (hCG)
Control
ACTIVE COMPARATOR12 healthy age-related men were stimulated with human chorionic gonadotropin (hCG)
Interventions
At 08 AM of day 0, all subjects underwent to a single intramuscular injection of hCG of 5000 IU
Eligibility Criteria
You may qualify if:
- Klinefelter syndrome diagnosis at kariotype evaluation for the study group
- Healthy age-matched men in the control group
You may not qualify if:
- previous or ongoing androgen therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AziendaUSLModena
Modena, 41126, Italy
Related Publications (1)
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.
PMID: 27188454BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ordinary Professor
Study Record Dates
First Submitted
May 30, 2016
First Posted
June 2, 2016
Study Start
February 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
June 7, 2016
Record last verified: 2016-06