E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 | 10021929 |
E.1.2 | Term | Infertility male |
|
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 evaluate the effect of Elocalcitol on total sperm motility (percentage) |
|
E.2.2 | Secondary objectives of the trial |
To determine the effect of Elocalcitol on: - Sperm parameters: forward sperm motility (percentage), absolute value of total and forward sperm motility, sperm morphology (atypical sperm cells) - conception rate - IL8 seminal plasma levels - Levels of leukocytes in the semen - The safety and tolerability |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Male patients aged 18-45 years - Infertility > 1 year and regular sexual intercourses with a fertile woman - Sperm parameters: total motility (a + b + c) 10-40% (this criteria should be met for both samples collected at V2 and V3, an analysis performed in the previous 6 months can replace the V2 evaluation) - Normal rheologic characteristic of the semen (appearance, consistency, liquefaction), volume and pH in the normal range - Negative urine, urethral swab and sperm culture - Ability to fully understand all study procedures and to provide written informed consent to study participation - Ability to comply with dosing and study visits scheduled for the duration of 7 months |
|
E.4 | Principal exclusion criteria |
- Genetic causes of infertility (tests performed before the enrolment are acceptable) - Varicocele and testicular hypotrophy by clinical evaluation - Patients who have undergone testicular surgery within the 3 months prior to the enrolment - Previous or present testicular cancer - Previous testicular trauma or torsion - General endocrinological disease (documented by clinical examination and hormonal laboratory tests: gonadotropins,Testosterone, tests performed in the previous 12 months will be accepted) - Present or previous cryptorchidism - Presence of antisperm antibodies - Evidence of hepatic disease (total bilirubin > 1.5 x upper limit of normal, or AST or ALT or alkaline phosphatase > 2 x upper limit of normal) - Evidence of renal insufficiency (creatinine > 1.5 x upper limit of normal) - Patients with other clinically significant systemic diseases - Patients unable and/or unlikely to comprehend and follow the study procedures and instructions - Patients who have received any investigational drug during the preceding 30 days or 5 times the plasma half-life (if known), whichever is longer, or who have previously participated in this trial - Patients who are abusers of alcohol and/or other drugs - Patients who intend to donate blood or blood products during the study or within one month following the completion of the study - Patients with allergy, hypersensitivity or other medical contraindications to Vitamin D - History of disturbed calcium, phosphorus or magnesium metabolism |
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E.5 End points |
E.5.1 | Primary end point(s) |
to estimate the effectiveness of Elocalcitol (BXL628) on the motility of the sperm |
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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 | No |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 | Information not present in EudraCT |
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
| |
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 | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |