E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Male diseases of the urinary and reproductive systems [C12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10021929 |
E.1.2 | Term | Infertility male |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
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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 |
The aim of this intervention is to investigate whether Denosumab can improve semen quality in a sub-group of infertile men. |
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E.2.2 | Secondary objectives of the trial |
Differences in clinical pregnancies, reproductive hormones, and differences in semen quality. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Infertile men >18 years and <60 years of age with reduced sperm production (Sperm concentration <20 mio/mL) - Serum AMH > 38 pmol/L |
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E.4 | Principal exclusion criteria |
- Men with chronic diseases (diabetes mellitus, thyroid disease, endocrine diseases requirering treatment such as sarcoidosis, tuberculosis, wegeners, vasculitis as well as inflammatory bowel diseases e.g. chron’s disease or ulcerative colitis etc). - Men with active or previous malignant disease - Men in treatment for osteoporosis - Serum ionized calcium < 1,18 mmol/L, Total calcium < 2.14 mmol/L or Albumin corrected calcium <2.17 mmol/L - Serum 25OHD < 25 nmol/L - eGFR <60 mL/min/1.73m^2 - Poor dental status og dental implants - Men with obstructive oligospermia (Sperm volume <0.9 mL) or who has been vasectomized - Latex allergy - Any case with indication for tesis biopsy, |
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E.5 End points |
E.5.1 | Primary end point(s) |
Differences in sperm production (sperm concentration millions/mL) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
80 days after intervention |
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E.5.2 | Secondary end point(s) |
- Difference in sperm quality (total number of sperm, total number of motile sperm, percentage of total motile sperm, total number of progressive motile sperm and percentage of progressive motile sperm, total number of morphologically normal sperm and percentage of morphologically normal sperm) - Difference in pregnancies achieved spontaneously or at IUI before day 180. - Difference in the number of live-born children where pregnancy is achieved spontaneously or at IUI before day 180. - Difference in the number of live-born children where pregnancy is achieved by artificial insemination (IVF and ICSI) before day 180. - Difference in the number of spontaneous abortions in the trial period. - Difference in serum levels of reproductive hormones (FSH, LH, AMH, Inhibin B and INSL3) on day 80. - Difference in serum levels of sex hormones (Testosterone, estradiol and SHBG) on day 80. - Difference in endocrine gonadal function (Inhibin B/FSH ratio and testosterone/LH ratio) on day 80. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.5 | Efficacy | No |
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 | 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 | No |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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 | No |
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
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End of trial is defined as last patient's last visit (LVLS) |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |