Last updated: 11/07/2018 10:07:57
Prospective sexual function study for BPH subjects
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A prospective study of sexual function in sexually active men treated for BPH
Trial description: This is an European double-blind, placebo controlled parallel group comparison ofDUODART (fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg, onecapsule daily) and placebo.PRIMARY OBJECTIVE:To assess the change in sexual function from baseline to 1 year in sexually active menwith at least moderate BPH who are treated with DUODART, compared to men treated with placebo .
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Changes from Baseline (BL) in total score from the full Men’s Sexual Health Questionnaire (MSHQ) at 12 months
Timeframe: Baseline and 12 months
Secondary outcomes:
Change from baseline in scores from the full Men’s Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 months
Timeframe: Baseline and Month 1, 3, 6, and 9
Number of participants reaching various thresholds of change in total MSHQ from baseline at 12 months
Timeframe: Baseline and 12 months
Change from Baseline in erectile dysfunction (ED) at 1, 3, 6, 9 and 12 months
Timeframe: Baseline and Month 1, 3, 6, 9 and 12
Change from Baseline in ejaculatory dysfunction (EjD) at 1, 3, 6, 9 and 12 months
Timeframe: Baseline and Month 1, 3, 6, 9 and 12
Change from Baseline in satisfaction score at 1, 3, 6, 9 and 12 months
Timeframe: Baseline and Month 1, 3, 6, 9 and 12
Change from Baseline in International Prostate Symptom Score (IPSS) Scores using the Observed Cases approach at 2 weeks, 1, 3, 6, 9, and 12 months
Timeframe: Baseline and Month 1, 3, 6, 9 and 12
Change From Baseline in Quality of Life (BPH Impact Index –BII scores) at 2 weeks, 1, 3, 6, 9, and 12 months
Timeframe: Baseline and Month 1, 3, 6, 9 and 12
Change from Baseline in perception of treatment benefit/satisfaction with treatment (Patient Perception of Study Medication - PPSM questionnaire scores) at 2 weeks, 1, 3, 6, 9, and 12 months
Timeframe: Baseline, Week 2, Month 1, 3, 6, 9 and 12
Change from baseline in total MSHQ scores from Baseline at 12 months among participants with IPSS improvement of >=2 points and >=3 points
Timeframe: Baseline and Month 12
Change from baseline in total MSHQ scores from Baseline at 12 months among participants with IPSS improvement of >=25 percent
Timeframe: Baseline and Month 12
Interventions:
Drug: Dutasteride plus tamsulosin
Drug: Placebo
Enrollment:
489
Observational study model:
Not applicable
Primary completion date:
2016-05-04
Time perspective:
Not applicable
Clinical publications:
Claus Roehrborn, Michael J. Manyak, Juan Manuel Palacios-Moreno, Timothy H. Wilson, Eril PM. Roos, Javier Cambronero Santos, Dimitrios Karanastasis, Janet Plastino, Francois Giuliano, Raymond C. Rosen. A prospective randomised placebo-controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJU Int. 2018;121(4):647-658.
Medical condition
Prostatic Hyperplasia
Product
dutasteride, dutasteride/tamsulosin, tamsulosin
Collaborators
Not applicable
Study date(s)
February 2013 to April 2016
Type
Interventional
Phase
4
Participation criteria
Sex
Male
Age
50+ years
Accepts healthy volunteers
No
- Males aged ≥50 years.
- Men must be sexually active. A man is considered sexually active if he has been engaged in sexual activity with a partner during the past 4 weeks (at least once) and plans to be active during the next 4 weeks (unless due to travel or other practical reasons). Men should confirm that they are in a stable relationship and expect to maintain their sexual activity over the next year.
- Total serum PSA >10.0 ng/mL at Visit 1 (screening).
- History or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE and/or rising PSA). 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.
Inclusion and exclusion criteria
Inclusion criteria:
- Males aged ≥50 years.
- Men must be sexually active. A man is considered sexually active if he has been engaged in sexual activity with a partner during the past 4 weeks (at least once) and plans to be active during the next 4 weeks (unless due to travel or other practical reasons). Men should confirm that they are in a stable relationship and expect to maintain their sexual activity over the next year.
- A confirmed clinical diagnosis of BPH.
- International Prostate Symptom Score (IPSS) ≥12 at Visit 1 (screening), with bother score 4 or less (score from the IPSS Quality of Life question 8).
- 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.
- Total serum prostate specific antigen (PSA ≥1.5 ng/mL (see exclusion criteria 1) at Visit 1 (screening).
- 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).
- 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.
- Able to swallow and retain oral medication.
- 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.
Exclusion criteria:
- Total serum PSA >10.0 ng/mL at Visit 1 (screening).
- History or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE and/or rising PSA). 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. Note: If total serum PSA is >4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, including consideration of prostate biopsy. Excluded medication and therapies -Current or prior use (within the periods given) of the following prohibited medications
- Any prior use of a 5α-reductase inhibitor (finasteride or dutasteride),
- Anti-cholinergics (e.g. oxybutynin, propantheline, tolerodine, solifenacin or darifenacin) within 1 month prior to visit 2 (baseline)
- An alpha-adrenoreceptor blocker (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 1 month prior to visit 2 (baseline)
- 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).
- Use of any drugs noted for propensity to cause gynaecomastia, or which could affect prostate volume, within 6 months prior to Visit 1 (screening).
- 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). -Current use (at the baseline visit or within the prior 1month) of:
- PDE-5 inhibitors for Erectile Dysfunction.
- Anabolic steroids.
- Drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin.
- Use of phytotherapy for BPH within 2 weeks prior to Visit 1 (screening) and/or predicted to need phytotherapy during the study.
- 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.
- Previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive or minimally invasive procedures to treat BPH. Recent Medical Procedures
- History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to Visit 1 (screening). Catheterisation (<10F) is acceptable with no time restriction. Medical history
- Presence of structural abnormalities in the Lower Urinary Tract or sexual organs (e.g. urethral stricture, Peyronie's Disease etc) that may cause LUTS or sexual dysfunction.
- History of AUR.
- Post-void residual volume >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.
- 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).
- History of ‘first dose’ hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy.
- 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.
- History of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy.
- Prior history of malignancies (other than basal cell carcinoma or squamous cell carcinoma of the skin) within the past 5 years. Subjects with an earlier history of malignancy who have had no evidence of disease for at least the past 5 years are eligible.
- History of hepatic impairment or abnormal liver function tests at Visit 1 (screening) (defined as ALT, AST or alkaline phosphatase >2 times the ULN, or total bilirubin >1.5 times the ULN (unless associated with predominantly indirect bilirubin elevation or Gilbert's syndrome).
- History of renal insufficiency, or serum creatinine >1.5 times the upper limit of normal at Visit 1 (screening).
- Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to the Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
- History or current evidence of drug or alcohol abuse within the previous 12 months.
- History or presence of any serious and/or unstable pre-existing psychiatric disorder or other conditions that in the opinion of the Investigator or GSK Medical Monitor, could interfere with subject’s safety, obtaining informed consent, compliance to the study procedures, or confound the results of the study.
Trial location(s)
Location
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Status
Study Complete
Location
GSK Investigational Site
Duelmen, Nordrhein-Westfalen, Germany, 48249
Status
Study Complete
Location
GSK Investigational Site
Wahroonga, New South Wales, Australia, 2076
Status
Study Complete
Location
GSK Investigational Site
Strausberg, Brandenburg, Germany, 15344
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hettstedt, Sachsen-Anhalt, Germany, 06333
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wedel, Schleswig-Holstein, Germany, 22880
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44225
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Alcazar de San Juan (Ciudad Real), Spain, 13600
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Buchholz, Niedersachsen, Germany, 21244
Status
Study Complete
Location
GSK Investigational Site
Oranienburg, Brandenburg, Germany, 16515
Status
Study Complete
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Study Complete
Location
GSK Investigational Site
Kippa-Ring, Queensland, Australia, 4021
Status
Study Complete
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24143
Status
Study Complete
Location
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52064
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Leipzig, Sachsen, Germany, 04109
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sydney, New South Wales, Australia, 2000
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2016-05-04
Actual study completion date
2016-05-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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