E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Benign prostatic hyperplasia |
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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 | 10004446 |
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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 compare the effect of LY500307 once daily for 24 weeks versus placebo treatment in improving the IPSS in men with LUTS and prostatic enlargement secondary to BPH. |
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E.2.2 | Secondary objectives of the trial |
To compare the effect of 24 weeks of LY500307 versus placebo treatment on the TPV as measured by TRUS. - To evaluate the effect of 24 weeks of LY500307 versus placebo treatment on Qmax. - To evaluate the effect of 24 weeks of LY500307 versus placebo treatment on: BPH-related QoL assessed by IPSS-QoL Index; and IPSS storage, voiding, and nocturia subscores. - To evaluate the effect of 24 weeks of LY500307 versus placebo treatment on PSA. - To evaluate LY500307 PK and factors affecting LY500307 exposure in men with LUTS and prostatic enlargement secondary to BPH. - To evaluate the relationship between LY500307 exposure and clinical efficacy as well as safety measures. - To assess the safety of LY500307 once daily for 24 weeks in the treatment of men with LUTS and prostatic enlargement secondary to BPH |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male patients with a history of BPH and moderate-to-severe LUTS due to prostate enlargement, who are at least 45 years of age and who have given informed consent, are eligible to participate in this study. Eligible patients must: Have an IPSS >/=13 at the placebo lead-in visit (Visit 2). Have a TPV by TRUS >/=30 mL at Visit 2. Show signs of bladder outlet obstruction as defined by a peak urinary flow rate (Qmax) >/=4 and </=15 mL/sec at Visit 2. Have a PSA >/=1.4 and </=10 ng/mL at screening (Visit 1). If, at screening, the patient s PSA is >4 ng/mL, prostate cancer must be excluded via a documented prostate biopsy within 12 months of Visit 1 and prior to the patient s Visit 2. Demonstrate a Post Void Residual (PVR) </=300 mL by ultrasound at Visit 2. Have not received the following excluded treatments within the specified time period: oFinasteride or dutasteride for at least 6 months prior to Visit 2. oAny alpha-adrenergic antagonists for at least 4 weeks prior to Visit 2. oAny other non-experimental BPH therapy (including an herbal preparation) for at least 4 weeks prior to Visit 2. oAny other experimental or off-label BPH therapy such as injectable therapies with a protracted effect for at least 6 months prior to Visit 2. oAny overactive bladder treatment for at least 4 weeks prior to Visit 2. oAny erectile dysfunction (ED) treatment, which may include oral phosphodiesterase (PDE) type 5 inhibitors or devices for at least 4 weeks prior to Visit 2. Have a morning fasting total testosterone (TT) concentration >/=300 ng/dL at screening (Visit 1). If hyperlipidemic, based on history, be on stable statin treatment as determined by the investigator for at least 2 months prior to Visit 2. |
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E.4 | Principal exclusion criteria |
Patients will be excluded from study participation if they: Have a history of BPH-related invasive procedures (for example, transurethral prostatectomy [TURP], open prostatectomy, and minimally invasive procedures that include thermal-based therapies, transurethral microwave treatment, transurethral needle ablation, and stents). Have active cardiovascular disease as evidenced by the following: oRecent myocardial infarction (MI), unstable angina, stroke, or transient ischemic attack (TIA) within 6 months of Visit 2. oRecent coronary intervention that includes coronary artery bypass surgery, percutaneous coronary artery intervention, or stent placement within 6 months of Visit 2. oRecent history of positive stress tests without any written documentation of effective intervention within 6 months of Visit 2. oEvidence of heart disease categorized as ≥Class III functional classification of New York Heart Association (NYHA) within 6 months of Visit 2. Have known or suspected history of prostate cancer, breast cancer, or other clinically significant neoplastic disease (other than squamous cell or basal cell carcinoma of skin). Have a history of deep venous thrombosis or pulmonary embolism disease. Have moderate to severe renal insufficiency (defined as an estimated glomerular filtration rate (eGFR) <50 mL/min/1.73m2 calculated from the Modification of Diet in Renal Disease [MDRD] formula [Huang et al. 2009]). Have a HbA1c >9.0%. Are on testosterone replacement therapy or on drugs that influence the hypothalamus-pituitary-gonadal axis, which may include any estrogen preparation, selective estrogen-receptor modulators (SERMs), gonadotropin releasing hormone (GnRH) agonists/antagonists, or androgen receptor antagonists within1 month prior to Visit 1. Patients on stable doses of thyroid replacement therapy will be allowed in this study. Are on pharmacological treatment other than statins for hyperlipidemia. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The mean change in IPSS total score from baseline to endpoint. |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
- same IMP used at different dosage |
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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.8.4.1 | 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 |
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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
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Ultima visita dell`ultimo paziente inserito nella sperimentazione |
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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 | 5 |
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 |