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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01777269




Registration number
NCT01777269
Ethics application status
Date submitted
24/01/2013
Date registered
28/01/2013

Titles & IDs
Public title
Prospective Sexual Function Study for BPH Subjects
Scientific title
A Prospective Study of Sexual Function in Sexually Active Men Treated for BPH
Secondary ID [1] 0 0
2012-002047-26
Secondary ID [2] 0 0
116115
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Hyperplasia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dutasteride plus tamsulosin
Treatment: Drugs - Placebo

Experimental: Duodart - Fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg. A capsule once daily during 12 months

Placebo comparator: Sugar Pill - A capsule once daily during 12 months


Treatment: Drugs: Dutasteride plus tamsulosin
Take 1 capsule daily

Treatment: Drugs: Placebo
Take one capsule daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months
Timepoint [1] 0 0
Baseline and 12 months
Secondary outcome [1] 0 0
Change From Baseline in Scores From the Full Men's Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months
Timepoint [1] 0 0
Baseline and Month 1, 3, 6, and 9
Secondary outcome [2] 0 0
Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months
Timepoint [2] 0 0
Baseline and 12 months
Secondary outcome [3] 0 0
Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months
Timepoint [3] 0 0
Baseline and Month 1, 3, 6, 9 and 12
Secondary outcome [4] 0 0
Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months
Timepoint [4] 0 0
Baseline and Month 1, 3, 6, 9 and 12
Secondary outcome [5] 0 0
Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months
Timepoint [5] 0 0
Baseline and Month 1, 3, 6, 9 and 12
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Baseline and Month 1, 3, 6, 9 and 12
Secondary outcome [7] 0 0
Change From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months
Timepoint [7] 0 0
Baseline and Month 1, 3, 6, 9 and 12
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Baseline, Week 2, Month 1, 3, 6, 9 and 12
Secondary outcome [9] 0 0
Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=2 Points and >=3 Points
Timepoint [9] 0 0
Baseline and Month 12
Secondary outcome [10] 0 0
Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent
Timepoint [10] 0 0
Baseline and Month 12

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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 5a-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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/04/2016
Sample size
Target
Accrual to date
Final
489
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [2] 0 0
GSK Investigational Site - Sydney
Recruitment hospital [3] 0 0
GSK Investigational Site - Wahroonga
Recruitment hospital [4] 0 0
GSK Investigational Site - Herston
Recruitment hospital [5] 0 0
GSK Investigational Site - Kippa-Ring
Recruitment hospital [6] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [7] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [8] 0 0
GSK Investigational Site - Malvern
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2076 - Wahroonga
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4021 - Kippa-Ring
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Garches
Country [2] 0 0
France
State/province [2] 0 0
Nantes cedex 2
Country [3] 0 0
France
State/province [3] 0 0
Nîmes cedex 9
Country [4] 0 0
France
State/province [4] 0 0
Orleans
Country [5] 0 0
France
State/province [5] 0 0
Paris Cedex 13
Country [6] 0 0
France
State/province [6] 0 0
Thouars
Country [7] 0 0
Germany
State/province [7] 0 0
Bayern
Country [8] 0 0
Germany
State/province [8] 0 0
Brandenburg
Country [9] 0 0
Germany
State/province [9] 0 0
Hessen
Country [10] 0 0
Germany
State/province [10] 0 0
Niedersachsen
Country [11] 0 0
Germany
State/province [11] 0 0
Nordrhein-Westfalen
Country [12] 0 0
Germany
State/province [12] 0 0
Sachsen-Anhalt
Country [13] 0 0
Germany
State/province [13] 0 0
Sachsen
Country [14] 0 0
Germany
State/province [14] 0 0
Schleswig-Holstein
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Eisleben
Country [17] 0 0
Greece
State/province [17] 0 0
Argos
Country [18] 0 0
Greece
State/province [18] 0 0
Athens
Country [19] 0 0
Greece
State/province [19] 0 0
Larisa
Country [20] 0 0
Hungary
State/province [20] 0 0
Budapest
Country [21] 0 0
Hungary
State/province [21] 0 0
Debrecen
Country [22] 0 0
Hungary
State/province [22] 0 0
Miskolc
Country [23] 0 0
Hungary
State/province [23] 0 0
Nyíregyháza
Country [24] 0 0
Hungary
State/province [24] 0 0
Szentes
Country [25] 0 0
Netherlands
State/province [25] 0 0
Almere
Country [26] 0 0
Netherlands
State/province [26] 0 0
Beek
Country [27] 0 0
Netherlands
State/province [27] 0 0
Doetinchem
Country [28] 0 0
Netherlands
State/province [28] 0 0
EDE
Country [29] 0 0
Netherlands
State/province [29] 0 0
Eindhoven
Country [30] 0 0
Netherlands
State/province [30] 0 0
Sneek
Country [31] 0 0
Netherlands
State/province [31] 0 0
Utrecht
Country [32] 0 0
Netherlands
State/province [32] 0 0
Winterswijk
Country [33] 0 0
Spain
State/province [33] 0 0
Alcazar De San Juan (Ciudad Real)
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Bormujo (Sevilla)
Country [36] 0 0
Spain
State/province [36] 0 0
Cadiz
Country [37] 0 0
Spain
State/province [37] 0 0
Coslada
Country [38] 0 0
Spain
State/province [38] 0 0
Getafe/Madrid
Country [39] 0 0
Spain
State/province [39] 0 0
Granada
Country [40] 0 0
Spain
State/province [40] 0 0
Guadalajara
Country [41] 0 0
Spain
State/province [41] 0 0
Madrid
Country [42] 0 0
Spain
State/province [42] 0 0
Marbella
Country [43] 0 0
Spain
State/province [43] 0 0
Mendaro, Guipuzcoa
Country [44] 0 0
Spain
State/province [44] 0 0
Murcia
Country [45] 0 0
Spain
State/province [45] 0 0
Toledo
Country [46] 0 0
Spain
State/province [46] 0 0
Vitoria- Gasteiz

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01777269