The Effect of Testosterone Replacement on the High Density Lipoprotein Cholesterol Subgroups
Phase 4 Study That Compares the High Density Lipoprotein Cholesterol (HDL) Cholesterol Subgroups of the Patients With Congenital Hypogonadotrophic Hypogonadism With That of the Healthy Control Subjects, and Investigates the Effect of Testosterone Treatment on HDL Subgroups.
1 other identifier
interventional
140
1 country
1
Brief Summary
The study is designed to answer the following questions:
- 1.Is there any difference between the compositions of the HDL cholesterol subpopulations of patients with hypogonadism and the healthy controls.
- 2.What is the effect of testosterone replacement therapy on the distributions of HDL subgroups.
- 3.Is there any difference between the effects of the two different testosteron replacement regiments
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2008
Typical duration for phase_4
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
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 12, 2011
CompletedFirst Posted
Study publicly available on registry
October 18, 2011
CompletedOctober 18, 2011
October 1, 2011
2.4 years
October 12, 2011
October 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in the HDL cholesterol levels and the HDL subgroups
The HDL subfractions were measured by polyethylene glycol (PEG) precipitation technique. Two different reagents were prepared in different PEG concentrations and pH values. The supernatant of the solution precipitated with reagent A contained total HDL cholesterol while the supernatant of the solution precipitated with reagent B, contained only the HDL3 subclass. The cholesterol was then quantified by enzymatic with CHOD-PAP reagent (Olympus Diagnostics GmbH, Hamburg, Germany). HDL2 cholesterol was measured by calculating the difference between total HDL and the HDL3 subclass.
6 months
Study Arms (2)
Testosterone 250mg injection,
ACTIVE COMPARATORTestosterone transdermal application
ACTIVE COMPARATORInterventions
The combination of 4 different testosterone esthers (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaproate and 100 mg testosterone decanoate) injected in 3 weeks intervals.
Application of testosterone 50mg transdermal gel in every night
Eligibility Criteria
You may qualify if:
- Congenital hypogonadotrophic hypogonadism,
- Male sex
You may not qualify if:
- Previous history of androgen replacement,
- any chronic disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gulhane School of Medicine
Ankara, 06018, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 12, 2011
First Posted
October 18, 2011
Study Start
September 1, 2008
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
October 18, 2011
Record last verified: 2011-10