Treatment of Testosterone deficiency in men with Sleep Apnoea Syndrome utilising Nebido therapy.
- Conditions
- Sleep ApnoeaHypogonadism- testosterone deficiency syndromeMedDRA version: 9.1Level: LLTClassification code 10021011Term: Hypogonadism maleMedDRA version: 9.1Level: LLTClassification code 10040977Term: Sleep apnoea
- Registration Number
- EUCTR2008-001459-23-GB
- Lead Sponsor
- ikolai Sleep Monitoring Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
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
or
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
-Dearcreased bone mineral density
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method