E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sleep Apnoea Hypogonadism- testosterone deficiency syndrome |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021011 |
E.1.2 | Term | Hypogonadism male |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10040977 |
E.1.2 | Term | Sleep apnoea |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the effects of NEBIDO therapy for hypogonadism on the parameters of sleep apnoea syndrome |
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E.2.2 | Secondary objectives of the trial |
To determine the effect of NEBIDO therapy on symptoms of hypogonadism such as dimished libido, erectile quality, mood changes, waist circumference and Body Mass Index
To find out the tolerability of NEBIDO therapy in patients with sleep apnoea syndrome when given in physiological doses. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
-Improvement of daytime sleepiness by assessing the patient employing the Epworth Sleepiness Scale (before and after treatment) -Incidence of oxyhaemoglobin desturation dips of 4% or lower per hour -The sleep apnoea index (number of events per hour)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
End of trial will be defined as the last visit of the last subject
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |