BPH (Benign prostatic hyperplasia) MedDRA version: 15.0 Level: SOC Classification code 10038604 Term: Reproductive system and breast disorders System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 15.0 Level: PT Classification code 10004446 Term: Benign prostatic hyperplasia System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: Duodart
Product Name: Duodart
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Males aged =50 years. 2. Men must be sexually active. 3. A confirmed clinical diagnosis of BPH. 4. International Prostate Symptom Score (IPSS) > or = 12 at Visit 1 (screening), with bother score 4 or less (score from the IPSS Quality of Life question 8). 5. Prostate volume =30 cc (by transrectal ultrasonography; TRUS). Measurement should be available by the baseline visit and should have been made /arranged at the screening visit or within the previous 6 months. 6. Total serum prostate specific antigen (PSA) =1.5 ng/mL (but see exclusion criteria 1) at Visit 1 (screening). 7. Willing and able to give signed written informed consent and comply with study procedures, including the ability to participate in the study for the full 1 year (or 18 months if necessary because of a persistent sexual AE). 8. Fluent and literate in local language with the ability to read, comprehend and record information on the MSHQ, IPSS, PPSM, BPH Impact Index (BII) and C-SSRS questionnaires. 9. Able to swallow and retain oral medication. 10. Men with a female partner of childbearing potential must either agree to use effective contraception or have had a prior vasectomy. Contraception must be used from 2 weeks prior to administration of the first dose of study treatment until at least 5 half-lives for the drug (45 days) plus 3 months (i.e. a total of 4.5 months) to allow clearance of any altered sperm after the last dose of study treatment. French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study treatment that may impact subject eligibility is provided in the SmPC for DUODART. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Total serum PSA >10.0 ng/mL at Visit 1 (screening). 2. History or evidence of prostate cancer. Subjects with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study. 3. Current or prior use (within the periods given) of the following prohibited medications i. Any prior use of a 5a-reductase inhibitor (finasteride or dutasteride), ii. Anti-cholinergics (e.g. oxybutynin, propantheline, tolerodine, solifenacin or darifenacin) within 1 month prior to visit 2 (baseline) iii. An alpha-adrenoreceptor blocker (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 1 month prior to visit 2 (baseline) iv. Use of any drugs with anti-androgenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents) within the 6 months prior to visit 1 (screening). v. Use of any drugs noted for propensity to cause gynaecomastia, or which could affect prostate volume, within 6 months prior to Visit 1 (screening). vi. Use of any investigational or marketed study drug within 30 days or 5 half-lives of the drug in question, (whichever is longer), preceding visit 2 (baseline). 4. Current use (at the baseline visit or within the prior 1month) of: PDE-5 inhibitors, Anabolic steroids, Drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin. 5. Use of phytotherapy for BPH within 2 weeks prior to Visit 1 (screening) and/or predicted to need phytotherapy during the study. 6. History of a known (immediate or delayed) hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to the study medication or excipients that, in the opinion of the Investigator or GSK, contraindicate their participation. 7. Previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive or minimally invasive procedures to treat BPH. 8. History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to Visit 1 (screening). Catheterisation (100 mL (suprapubic ultrasound) at Visit 1 (screening) or a recorded PVR above this level on any previous examination. Measurement should be available by the baseline visit and should have been made /arranged at the screening visit or within the previous 6 months. 12. Any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections). 13. History of ‘first dose’ hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy. 14. History of postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury. 15. History of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy. 16. Prior history of malignancies (other than basal cell carcinoma or squamous cell carcinoma of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the change in sexual function from baseline in sexually active men with at least moderate BPH (international prostate symptom score - IPSS = or > 12) who are treated with DUODART, compared to men treated with placebo at 1 year. Change in sexual function will be assessed by change in total score from the full men’s sexual health questionnaire (MSHQ) which has domains for erectile dysfunction, ejaculatory function and libido.;Secondary Objective: Changes in sexual function from baseline using the full Men’s Sexual Health Questionnaire (MSHQ). Assess percentage of subjects reaching various thresholds of change in total MSHQ at 12 months. Changes in erectile dysfunction (ED), ejaculatory dysfunction (EjD), and libido domains (of the MSHQ). Assess changes in BPH symptoms, quality of life, perception of treatment benefit/satisfaction with treatment and relationship of these changes to sexual function. Assess changes in MSHQ in subpopulations of men with good BPH symptomatic response that is subjects with IPSS improvement of =2 and =3 points from baseline and, separately to assess changes in MSHQ scores at 12 months in subpopulations of men with =25% improvement from baseline. EXPLORATORY OBJECTIVE: assess the persistence of sexual adverse events by following up those men with sexual adverse events who withdraw from the study or men with sexual adverse events present at the last visit of the treatment phase. ;Primary end point(s): To assess the change in sexual function from baseline to 1 year in sexually active menwith at least moderate BPH (international prostate symptom score - IPSS = or > 12) whoare treated with DUODART, compared to men treated with placebo. Change in sexual function will be assessed by change in total score from the full men’s sexual health questionnaire (MSHQ) which has domains for erectile dysfunction, ejaculatory function and libido.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in sexual function from baseline using the full Men’s Sexual Health Questionnaire (MSHQ). Assess percentage of subjects reaching various thresholds of change in total MSHQ at 12 months. Changes in erectile dysfunction (ED), ejaculatory dysfunction (EjD), and libido domains (of the MSHQ). Assess changes in BPH symptoms, quality of life, perception of treatment benefit/satisfaction with treatment and relationship of these changes to sexual function. Assess changes in MSHQ in subpopulations of men with good BPH symptomatic response that is subjects with IPSS improvement of =2 and =3 points from baseline and, separately to assess changes in MSHQ scores at 12 months in subpopulations of men with =25% improvement from baseline. EXPLORATORY OBJECTIVE: assess the persistence of sexual adverse events by following up those men with sexual adverse events who withdraw from the study or men with sexual adverse events present at the last visit of the treatment phase. ;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Australia, France, Germany, Greece, Hungary, Italy, Netherlands, Spain
Contacts
Public ContactClincial Trials Helpdesk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed