E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bening Prostate Hyperplasia |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014840 |
E.1.2 | Term | Enlarged prostate (benign) |
|
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 find an effective dosing regimen that provides a clinical effect defined as a reduction in International Prostate Symptom Score (IPSS) at 3 months after dosing in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) |
|
E.2.2 | Secondary objectives of the trial |
Efficacy parameters: IPSS over the trial period (up to a maximum of one year) Total prostate volume (TPV) Uroflowmetry parameters and post-void residual volume (PVR) Severity of storage symptoms such as frequency, urgency, nocturia, and mean volume voided per micturition Disease-specific and generic quality of life (QoL) Serum prostate-specific antigen (PSA) levels Safety parameters: Serum testosterone levels Sexual function Serum lipids (triglycerides, cholesterol, high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol) levels Insulin sensitivity Body composition Bone mineral density (BMD) and bone turnover QT/QTc interval Safety and tolerability profiles Additional objective: Pharmacokinetics over the trial period
|
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
1) QT-QTc and PK substudy
2) DEXA substudy
|
|
E.3 | Principal inclusion criteria |
1. Signed informed consent obtained before any trial-related activity is performed 2. Men, aged 50 or older 3. Clinical signs and symptoms of BPH for ≥6 months 4. Moderate to severe LUTS at screening, as defined by IPSS ≥13 5. An IPSS QoL score of ≥3 at screening 6. Prostate specific antigen (PSA) at screening ≤10 ng/mL (responsibility of the Investigator to rule out prostate cancer when PSA is >4 ng/mL, except in the USA where patients with a PSA >4 and ≤10 ng/mL should undergo a prostatic biopsy or have a negative prostatic biopsy within 12 months prior to participation in the trial) 7. Maximum urinary flow (Qmax) ranging between 5 to 15 mL/second with a minimum voided volume >125 mL at screening
|
|
E.4 | Principal exclusion criteria |
1. Post void residual volume (PVR) >250 mL 2. Stone in the bladder or urethra causing symptoms 3. Acute or chronic prostatitis 4. Interstitial cystitis / painful bladder syndrome 5. Acute or recurrent urinary tract infections 6. History of acute urinary retention (AUR) 7. Lower urinary tract instrumentation (including prostate biopsy) within 30 days of dosing at Visit 2 8. Clinical evidence of any of the following urinary tract conditions: a) Mullerian duct cysts b) Atonic, decompensated, or hypocontractile bladder c) Detrusor-sphincter dyssynergia (contraction of the detrusor without sphincter relaxation) 9. History of any of the following pelvic conditions: a) Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or open lower colonic or rectal surgery b) Pelvic radiotherapy c) Any prior surgical procedure of the urinary tract, including minimally invasive LUTS/BPH therapies d) Lower tract malignancy or trauma 10. Clinically significant microscopic hematuria at screening 11. History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance <30 mL/minute at screening 12. Systolic blood pressure >180 or <90 mmHg or diastolic blood pressure >110 or <50 mmHg at screening or malignant hypertension 13. Any causes other than BPH, which may affect evaluation of symptoms of urine flow (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, and bladder malignancy) as judged by the Investigator 14. Use of any prohibited therapies* 15. Elevated liver function tests at screening: a) Aspartate aminotransferase (AST), alanine aminotranseferase (ALT), alkaline phosphatase (ALP) >2 times the upper limit of normal b) Total bilirubin >1.5 times the upper limit of normal 16. QTc interval on the screening ECG >450 ms, or a family history of long QT syndrome 17. Any clinically significant disorder (other than BPH) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, or any other condition, which may affect the patient’s health or the outcome of the trial as judged by the Investigator 18. Diagnosed cancer within the last 5 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin 19. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema 20. Mental incapacity or language barrier precluding adequate understanding or co-operation 21. History or current evidence of drug, alcohol, or substance abuse within 6 months prior to screening 22. Hypersensitivity towards any component of the investigational medicinal product (IMP) 23. Previous participation in any degarelix trial
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
To find an effective dosing regimen that provides a clinical effect defined as a reduction in International Prostate Symptom Score (IPSS) at 3 months after dosing in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) |
|
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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
The follow-up period will be up to a maximum of one year. End of Trial (EoT) visit will occur at the time of stopping the trial. The Investigator will follow-up on each patient with a telephone call after a decision to stop the trial has been taken.
|
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |