EUCTR2008-001459-23-GB
Active, not recruiting
Not Applicable
Treatment of Testosterone deficiency in men with Sleep Apnoea Syndrome utilising Nebido therapy.
ikolai Sleep Monitoring Clinic0 sitesJune 18, 2008
DrugsNebido
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ikolai Sleep Monitoring Clinic
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •20 hypogonadal men requiring Nebido therapy who have proven sleep apnoea syndrome
- •Hypogonadism is defined as:
- •Total testosterone of \<8 nmol or free testosterone of \< 180 pmol/L
- •Total testosterone between 8\-12 nmol/L or free testesterone .180\-250 pmol/L who are symptomatic of hypogonadism:
- •\- Diminished libido and erectile quality and frequency
- •\-Changes in mood and cognitive ability
- •\-Sleep disturbance
- •\-Decrease in lean body mass
- •\-Increase in visceral fat
- •\-Decrease in body hair and skin alterations
Exclusion Criteria
- •The patients are ineligible for the study if there is a current or past history of:
- •\- Androgen dependent carcinoma of prostate or male mammary galnd
- •\-Liver tumours
- •\-Hypersensitivity to Nebido or any of its incipients
- •\-Symptoms or signs of prostatic enlargement
- •\-Polycythaemia (Haematocrit of 55% or more)
- •\-Any general systemic illness
- •\-Severe cardiac, hepatic or renal insufficiency
- •or those deemed unable to comply with the requirements of the protocol
Outcomes
Primary Outcomes
Not specified
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