Testosterone Replacement Therapy Decreases Plasma Paraoxonase 1 Enzyme Activity In Male Patients With Hypogonadism
This study has been completed.
Sponsor:
Gulhane School of Medicine
Information provided by:
Gulhane School of Medicine
ClinicalTrials.gov Identifier:
NCT01107067
First received: April 19, 2010
Last updated: NA
Last verified: May 2008
History: No changes posted
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Purpose
The purpose of this study is investigating the effect of testosterone treatment on paraoxonase level in male patients with hypogonadotrophic hypogonadism
| Condition | Intervention | Phase |
|---|---|---|
|
Hypogonadism |
Drug: Sustanon |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | Phase IV Study to Investigate the Effect of Testosterone Treatment on Paraoxonase Level in Male Patients With Hypogonadotrophic Hypogonadism |
Resource links provided by NLM:
Drug Information available for:
Testosterone propionate
Methyltestosterone
Testosterone cypionate
Testosterone
Testosterone enanthate
U.S. FDA Resources
Further study details as provided by Gulhane School of Medicine:
Primary Outcome Measures:
- paraoxonase level after testosterone treatment
| Enrollment: | 32 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: testosterone replacement therapy |
Drug: Sustanon
250 mg/21 days
Other Name: no name
|
Eligibility| Ages Eligible for Study: | 20 Years to 25 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Volunteers patients with hypogonadism
Exclusion Criteria:
- Coronary heart disease
- Other pituitary/hypothalamic disorders or other non-hypogonadism diseases
- None was receiving vitamins, lipid-lowering drugs, or other medications known to interfere with PON1 activity, lipid profile, or gonadal function
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Gulhane School of Medicine Department of Endocrinology and Metabolism |
| ClinicalTrials.gov Identifier: | NCT01107067 History of Changes |
| Other Study ID Numbers: | aa001 |
| Study First Received: | April 19, 2010 |
| Last Updated: | April 19, 2010 |
| Health Authority: | Turkey: Ministry of Health |
Keywords provided by Gulhane School of Medicine:
|
hypogonadism paraoxonase Hipogonadism |
Additional relevant MeSH terms:
|
Hypogonadism Gonadal Disorders Endocrine System Diseases Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Androgens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents |
ClinicalTrials.gov processed this record on May 19, 2013