male infertility MedDRA version: 9.1 Level: LLT Classification code 10021929 Term: Infertility male
Conditions
Interventions
Product Name: Elocalcitol
Product Code: BXL628
Pharmaceutical Form: Capsule, soft
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the pla
Sponsors
BIOXELL SPA
Eligibility
Sex/Gender
Male
Inclusion criteria
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 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of Elocalcitol on total sperm motility (percentage);Secondary Objective: 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;Primary end point(s): to estimate the effectiveness of Elocalcitol (BXL628) on the motility of the sperm | — |
Countries
Italy
Outcome results
None listed