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CompletedNCT01777269Updated Aug 20, 2018Results posted

Prospective Sexual Function Study for BPH Subjects

A Phase 4 interventional study of Dutasteride plus tamsulosin and Placebo in Prostatic Hyperplasia, sponsored by GlaxoSmithKline. Completed at 67 sites in 7 countries. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-08-20.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
489
Allocation
Randomized
Ages
50 Years and older
Sex
Male
01

Study summary

This is an European double-blind, placebo controlled parallel group comparison of DUODART (fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg, one capsule daily) and placebo.

PRIMARY OBJECTIVE:

To assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH who are treated with DUODART, compared to men treated with placebo .

Read the detailed description

This is an European double-blind, placebo controlled parallel group comparison of DUODART (fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg, one capsule daily) and placebo. Men eligible at screening will be randomised, after a 4 week placebo run-in, to the 2 treatment groups in a 1:1 ratio. All men will receive standardised lifestyle advice (primarily concerning weight management and exercise) relevant to maintaining sexual function. Men will also receive a standardised lifestyle advice leaflet for BPH. The double blind phase will continue for 12 months, with assessment visits at 2 weeks and at months 1, 3, 6, 9 and a final visit at month 12. Subjects with sexual adverse events during the double blind phase will continue to be followed at scheduled study visits until resolution of the adverse event or at a visit 6 months after the last dose of study medication, whichever is sooner.

PRIMARY OBJECTIVE:

To assess the change in sexual function from baseline to 1 year 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 . 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.

02

Conditions studied

  • Prostatic Hyperplasia
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 489 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
489 participants (actual)

Study arms

  • Experimental
    Duodart

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

    Drug: Dutasteride plus tamsulosin

  • Placebo comparator
    Sugar Pill

    A capsule once daily during 12 months

    Drug: Placebo

Interventions

  • DrugDutasteride plus tamsulosin

    Take 1 capsule daily

  • DrugPlacebo

    Take one capsule daily

06

What researchers measure

Primary outcomes

  1. Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months

    Total MSHQ score is composed of 3 domain scores: Erection score(ES)=sum of score for Questions (Q) 1 to 3(ranges from 0 to 15), Ejaculation score(EjS)=sum of scores for Q5 to 11(ranges from 1 to 35), Satisfaction score(SS)=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS. The total MSHQ score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analyzed using a mixed model repeated measures (MMRM) analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest double-blind (DB) treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s)

    Time frame: Baseline and 12 months

Secondary outcomes

  1. Change From Baseline in Scores From the Full Men's Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months

    Total MSHQ score is composed of 3 domain scores: ES=sum of score for Q 1 to 3(ranges from 0 to 15), EjS=sum of scores for Q5 to 11(ranges from 1 to 35), SS=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analysed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

    Time frame: Baseline and Month 1, 3, 6, and 9

  2. Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months

    Participants reaching thresholds of change in total MSHQ were assessed. Threshold values are defined as multiplicative factor. Threshold included +10 points, +20 points, +25 points, -10 points, -20 points, -25 points; where "+" indicates improvement and "-"indicates worsening. Treatment comparisons were done based on categories defined by these thresholds using Mantel-Haenszel test

    Time frame: Baseline and 12 months

  3. Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months

    Erection scale is a domain of MSHQ to assess erectile dysfunction. ES is the sum of score for questions 1 to 3. The score ranges from 0 (no erection) to 15 (strong erection). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

    Time frame: Baseline and Month 1, 3, 6, 9 and 12

  4. Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months

    Ejaculation scale is a domain of MSHQ to assess ejaculatory dysfunction. EjS is the sum of score for questions 5 to 11. The score ranges from 1 (could not ejaculate) to 35 (strong ejaculation). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

    Time frame: Baseline and Month 1, 3, 6, 9 and 12

  5. Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months

    Satisfaction scale is a domain of MSHQ to assess sexual relationship. SS is the sum of score for questions 13 to 18. The score ranges from 6 (extremely dissatisfied) to 30 (extremely satisfied). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

    Time frame: Baseline and Month 1, 3, 6, 9 and 12

  6. 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

    The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify urinary symptoms: Q1, incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. The score can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

    Time frame: Baseline and Month 1, 3, 6, 9 and 12

  7. Change From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months

    The BPH Impact Index (BII) is a 4-item, self-administered questionnaire evaluating the impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

    Time frame: Baseline and Month 1, 3, 6, 9 and 12

  8. 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

    Patient Perception of Study Medication (PPSM) is a 12-item questionnaire designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms. The total PPSM score ranges from 7 to 49, with higher scores indicating lower satisfaction. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9, 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

    Time frame: Baseline, Week 2, Month 1, 3, 6, 9 and 12

  9. Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=2 Points and >=3 Points

    Total MSHQ score is composed of 3 domain scores: ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Par. with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed. Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

    Time frame: Baseline and Month 12

  10. Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent

    Participants with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed.Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

    Time frame: Baseline and Month 12

07

Results

Posted Jul 14, 2017

Participant flow

This is a European double-blind, placebo-controlled, parallel-group study to assess the impact of dutasteride treatment on sexual function in men with moderate/severe Benign Prostatic Hyperplasia (BPH)

Participant flow — Overall Study
MilestonePlaceboDuodart
Started246243
Completed191184
Not completed5559
Withdrew: Adverse event2433
Withdrew: Lack of efficacy810
Withdrew: Protocol violation44
Withdrew: Participants reached stopping criteria11
Withdrew: Lost to follow-up40
Withdrew: Physician decision52
Withdrew: Withdrawal by subject99

Outcome measures

PrimaryChanges From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months

Total MSHQ score is composed of 3 domain scores: Erection score(ES)=sum of score for Questions (Q) 1 to 3(ranges from 0 to 15), Ejaculation score(EjS)=sum of scores for Q5 to 11(ranges from 1 to 35), Satisfaction score(SS)=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS. The total MSHQ score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analyzed using a mixed model repeated measures (MMRM) analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest double-blind (DB) treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s)

Time frame:
Baseline and 12 months
Reported as:
Least squares mean · Scores on a scale
Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months
Scores on a scalePlaceboDuodart
Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months-0.7 ± 0.78-8.7 ± 0.81
Statistical analysis
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -8.00 · 95% CI -10.22 to -5.79
SecondaryChange From Baseline in Scores From the Full Men's Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months

Total MSHQ score is composed of 3 domain scores: ES=sum of score for Q 1 to 3(ranges from 0 to 15), EjS=sum of scores for Q5 to 11(ranges from 1 to 35), SS=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analysed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

Time frame:
Baseline and Month 1, 3, 6, and 9
Reported as:
Least squares mean · Scores on a scale
Change From Baseline in Scores From the Full Men's Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months
Scores on a scalePlaceboDuodart
Month 1, n=193, 192-0.5 ± 0.68-4.6 ± 0.69
Month 3, n= 184, 181-0.5 ± 0.72-6.9 ± 0.73
Month 6, n=179, 164-0.8 ± 0.80-9.9 ± 0.83
Month 9, n=166, 146-0.8 ± 0.76-9.6 ± 0.79
Statistical analysis
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -4.11 · 95% CI -6.01 to -2.21Month 1
  • Placebo vs Duodart · Adjusted mean difference · p = <0.001 · Adjusted mean difference: -6.43 · 95% CI -8.45 to -4.41Month 3
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -9.04 · 95% CI -11.31 to -6.77Month 6
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -8.82 · 95% CI -10.96 to -6.67Month 9
SecondaryNumber of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months

Participants reaching thresholds of change in total MSHQ were assessed. Threshold values are defined as multiplicative factor. Threshold included +10 points, +20 points, +25 points, -10 points, -20 points, -25 points; where "+" indicates improvement and "-"indicates worsening. Treatment comparisons were done based on categories defined by these thresholds using Mantel-Haenszel test

Time frame:
Baseline and 12 months
Reported as:
Number · Participants
Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months
ParticipantsPlaceboDuodart
>= 2501
>= 2033
>= 10168
<= -25313
<= -20320
<= -102461
SecondaryChange From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months

Erection scale is a domain of MSHQ to assess erectile dysfunction. ES is the sum of score for questions 1 to 3. The score ranges from 0 (no erection) to 15 (strong erection). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

Time frame:
Baseline and Month 1, 3, 6, 9 and 12
Reported as:
Least squares mean · Scores on a scale
Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months
Scores on a scalePlaceboDuodart
Month 1, n=209, 215-0.3 ± 0.15-0.5 ± 0.15
Month 3, n= 202, 208-0.5 ± 0.17-0.7 ± 0.17
Month 6, n= 193, 188-0.6 ± 0.18-1.0 ± 0.19
Month 9, n=182, 169-0.5 ± 0.18-1.2 ± 0.19
Month 12, n= 175, 168-0.5 ± 0.19-1.0 ± 0.19
Statistical analysis
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.37 · Adjusted mean difference: -0.20 · 95% CI -0.62 to 0.23Month 1
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.33 · Adjusted mean difference: -0.24 · 95% CI -0.71 to 0.24Month 3
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.16 · Adjusted mean difference: -0.37 · 95% CI -0.88 to 0.15Month 6
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.009 · Adjusted mean difference: -0.68 · 95% CI -1.19 to -0.17Month 9
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.091 · Adjusted mean difference: -0.46 · 95% CI -0.99 to 0.07Month 12
SecondaryChange From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months

Ejaculation scale is a domain of MSHQ to assess ejaculatory dysfunction. EjS is the sum of score for questions 5 to 11. The score ranges from 1 (could not ejaculate) to 35 (strong ejaculation). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

Time frame:
Baseline and Month 1, 3, 6, 9 and 12
Reported as:
Least squares mean · Scores on a scale
Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months
Scores on a scalePlaceboDuodart
Month 1, n=210, 208-0.3 ± 0.42-3.2 ± 0.43
Month 3, n= 197, 196-0.5 ± 0.48-5.8 ± 0.48
Month 6, n= 191, 179-0.7 ± 0.53-7.5 ± 0.54
Month 9, n=177, 161-0.5 ± 0.52-7.6 ± 0.53
Month 12, n= 173, 164-0.6 ± 0.55-7.5 ± 0.56
Statistical analysis
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -2.89 · 95% CI -4.07 to -1.70Month 1
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -5.24 · 95% CI -6.59 to -3.90Month 3
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -6.82 · 95% CI -8.30 to -5.34Month 6
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -7.05 · 95% CI -8.51 to -5.59Month 9
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -6.92 · 95% CI -8.47 to -5.38Month 12
SecondaryChange From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months

Satisfaction scale is a domain of MSHQ to assess sexual relationship. SS is the sum of score for questions 13 to 18. The score ranges from 6 (extremely dissatisfied) to 30 (extremely satisfied). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

Time frame:
Baseline and Month 1, 3, 6, 9 and 12
Reported as:
Mean · Scores on a scale
Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months
Scores on a scalePlaceboDuodart
Month 1, n=200, 1970.1 ± 0.26-0.8 ± 0.26
Month 3, n= 189, 1820.4 ± 0.27-0.5 ± 0.28
Month 6, n= 185, 1680.2 ± 0.30-1.5 ± 0.31
Month 9, n=173, 153-0.0 ± 0.30-1.2 ± 0.32
Month 12, n= 169, 1520.3 ± 0.29-0.6 ± 0.30
Statistical analysis
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.012 · Adjusted mean difference: -0.94 · 95% CI -1.67 to -0.21Month 1
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.017 · Adjusted mean difference: -0.93 · 95% CI -1.69 to -0.17Month 3
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -1.73 · 95% CI -2.57 to -0.88Month 6
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.009 · Adjusted mean difference: -1.15 · 95% CI -2.01 to -0.30Month 9
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.047 · Adjusted mean difference: -0.83 · 95% CI -1.65 to -0.01Month 12
SecondaryChange From Baseline in International Prostate Symptom Score (IPSS) Scores Using the Observed Cases Approach at 2 Weeks, 1, 3, 6, 9, and 12 Months

The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify urinary symptoms: Q1, incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. The score can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

Time frame:
Baseline and Month 1, 3, 6, 9 and 12
Reported as:
Least squares mean · Scores on a scale
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
Scores on a scalePlaceboDuodart
Week 2, n=232, 234-1.5 ± 0.29-3.1 ± 0.29
Month1, n=222, 231-2.8 ± 0.33-3.4 ± 0.33
Month 3, n=217, 224-2.8 ± 0.33-4.1 ± 0.33
Month 6, n=206, 203-2.9 ± 0.36-4.6 ± 0.36
Month 9, n=193, 185-3.2 ± 0.38-4.5 ± 0.38
Month 12, n=187, 184-3.2 ± 0.41-5.2 ± 0.41
Statistical analysis
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -1.65 · 95% CI -2.45 to -0.85Week 2
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.24 · Adjusted mean difference: -0.55 · 95% CI -1.47 to 0.37Month 1
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.006 · Adjusted mean difference: -1.27 · 95% CI -2.19 to -0.36Month 3
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -1.73 · 95% CI -2.74 to -0.72Month 6
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.013 · Adjusted mean difference: -1.34 · 95% CI -2.40 to -0.28Month 9
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -1.97 · 95% CI -3.12 to -0.83Month 12
SecondaryChange From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months

The BPH Impact Index (BII) is a 4-item, self-administered questionnaire evaluating the impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

Time frame:
Baseline and Month 1, 3, 6, 9 and 12
Reported as:
Least squares mean · Scores on a scale
Change From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months
Scores on a scalePlaceboDuodart
Week 2, n=226, 227-0.3 ± 0.14-0.7 ± 0.14
Month1, n=216, 223-0.7 ± 0.13-0.7 ± 0.13
Month 3, n=211, 217-0.9 ± 0.15-1.1 ± 0.15
Month 6, n=201, 195-0.6 ± 0.17-1.2 ± 0.17
Month 9, n=188, 179-0.7 ± 0.16-1.2 ± 0.17
Month 12, n=183, 177-0.6 ± 0.18-1.2 ± 0.18
Statistical analysis
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.036 · Adjusted mean difference: -0.40 · 95% CI -0.78 to -0.03Week 2
  • Placebo vs Duodart · mixed-model repeated-measures · p = 1.00 · Adjusted mean difference: 0.00 · 95% CI -0.37 to 0.37Month 1
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.21 · Adjusted mean difference: -0.26 · 95% CI -0.67 to 0.15Month 3
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.009 · Adjusted mean difference: -0.62 · 95% CI -1.09 to -0.15Month 6
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.056 · Adjusted mean difference: -0.45 · 95% CI -0.91 to 0.01Month 9
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.023 · Adjusted mean difference: -0.58 · 95% CI -1.08 to -0.08Month 12
SecondaryChange 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

Patient Perception of Study Medication (PPSM) is a 12-item questionnaire designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms. The total PPSM score ranges from 7 to 49, with higher scores indicating lower satisfaction. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9, 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

Time frame:
Baseline, Week 2, Month 1, 3, 6, 9 and 12
Reported as:
Least squares mean · Scores on a scale
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
Scores on a scalePlaceboDuodart
Week 2, n=225, 227-0.4 ± 0.32-3.4 ± 0.32
Month1, n=216, 223-1.3 ± 0.38-3.4 ± 0.38
Month 3, n=211, 217-1.7 ± 0.41-3.8 ± 0.41
Month 6, n=201, 195-1.0 ± 0.44-3.6 ± 0.44
Month 9, n=188, 179-1.6 ± 0.45-2.9 ± 0.45
Month 12, n=182, 177-1.0 ± 0.49-4.6 ± 0.49
Statistical analysis
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -3.00 · 95% CI -3.89 to -2.10Week 2
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -2.10 · 95% CI -3.15 to -1.06Month 1
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -2.11 · 95% CI -3.25 to -0.98Month 3
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -2.53 · 95% CI -3.76 to -1.30Month 6
  • Placebo vs Duodart · mixed-model repeated-measures · p = 0.042 · Adjusted mean difference: -1.30 · 95% CI -2.56 to -0.05Month 9
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -3.51 · 95% CI -4.87 to -2.14Month 12
SecondaryChange From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=2 Points and >=3 Points

Total MSHQ score is composed of 3 domain scores: ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Par. with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed. Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

Time frame:
Baseline and Month 12
Reported as:
Least squares mean · Scores on a scale
Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=2 Points and >=3 Points
Scores on a scalePlaceboDuodart
IPSS improvement of >=2, n=152, 142-0.6 ± 0.81-8.4 ± 0.83
IPSS improvement of >=3, n=138,136-0.6 ± 0.86-8.0 ± 0.86
Statistical analysis
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -7.78 · 95% CI -10.07 to -5.49Par. with IPSS change from baseline \>=2 points improvement at any time post-baseline visit
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -7.39 · 95% CI -9.79 to -4.99Par. with IPSS change from baseline \>=3 points improvement at any time post-baseline visit
SecondaryChange From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent

Participants with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed.Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)

Time frame:
Baseline and Month 12
Reported as:
Least squares mean · Scores on a scale
Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent
Scores on a scalePlaceboDuodart
Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent-0.6 ± 0.86-8.3 ± 0.88
Statistical analysis
  • Placebo vs Duodart · mixed-model repeated-measures · p = <0.001 · Adjusted mean difference: -7.79 · 95% CI -10.22 to -5.35Par. with IPSS change from baseline \>=25 points improvement at any time post-baseline visit

Adverse events

Collected over Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to approximately 18 months).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—9/246 (3.7%)28/246 (11.4%)
Duodart—27/243 (11.1%)66/243 (27.2%)
Most frequent serious events
Showing 10 of 54
Most frequent serious events
EventPlaceboDuodart
PneumoniaInfections and infestations0/2462/243
Urinary tract infectionInfections and infestations0/2462/243
PresyncopeNervous system disorders0/2462/243
CystitisInfections and infestations0/2461/243
MeningitisInfections and infestations0/2461/243
Postoperative wound infectionInfections and infestations0/2461/243
Infected cystInfections and infestations0/2461/243
Respiratory tract infectionInfections and infestations0/2461/243
Cardiac failureCardiac disorders1/2461/243
Acute myocardial infarctionCardiac disorders0/2461/243
Most frequent other events
Most frequent other events
EventPlaceboDuodart
Erectile dysfunctionReproductive system and breast disorders16/24624/243
Retrograde ejaculationReproductive system and breast disorders3/24623/243
Libido decreasedPsychiatric disorders12/24620/243
Ejaculation disorderReproductive system and breast disorders2/24616/243

Baseline characteristics

Age, Continuous
Age, Continuous(Years)PlaceboDuodartTotal
Mean65.4 ± 6.4965.7 ± 6.5965.5 ± 6.53
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboDuodartTotal
Female000
Male246243489
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboDuodartTotal
African American/African Heritage123
American Indian or Alaska Native235
Asian - East Asian Heritage101
White - Arabic/North African Heritage303
White - White/Caucasian/European Heritage239237476
Mixed Race011
08

Study locations

67 sites
  • GSK Investigational Site
    Randwick, New South Wales 2031, Australia
  • GSK Investigational Site
    Sydney, New South Wales 2000, Australia
  • GSK Investigational Site
    Wahroonga, New South Wales 2076, Australia
  • GSK Investigational Site
    Herston, Queensland 4029, Australia
  • GSK Investigational Site
    Kippa-Ring, Queensland 4021, Australia
  • GSK Investigational Site
    Adelaide, South Australia 5000, Australia
  • GSK Investigational Site
    Heidelberg, Victoria 3084, Australia
  • GSK Investigational Site
    Malvern, Victoria 3144, Australia
  • GSK Investigational Site
    Garches, 92380, France
  • GSK Investigational Site
    Nantes cedex 2, 44277, France
  • GSK Investigational Site
    Nîmes cedex 9, 30029, France
  • GSK Investigational Site
    Orleans, 45100, France
  • GSK Investigational Site
    Paris Cedex 13, 75651, France
  • GSK Investigational Site
    Thouars, 79100, France
  • GSK Investigational Site
    Nuernberg, Bayern 90441, Germany
  • GSK Investigational Site
    Hagenow, Brandenburg 19230, Germany
  • GSK Investigational Site
    Oranienburg, Brandenburg 16515, Germany
  • GSK Investigational Site
    Strausberg, Brandenburg 15344, Germany
  • GSK Investigational Site
    Marburg, Hessen 35039, Germany
  • GSK Investigational Site
    Buchholz, Niedersachsen 21244, Germany
  • GSK Investigational Site
    Aachen, Nordrhein-Westfalen 52064, Germany
  • GSK Investigational Site
    Dortmund, Nordrhein-Westfalen 44225, Germany
  • GSK Investigational Site
    Duelmen, Nordrhein-Westfalen 48249, Germany
  • GSK Investigational Site
    Hettstedt, Sachsen-Anhalt 06333, Germany
  • GSK Investigational Site
    Leipzig, Sachsen 04109, Germany
  • GSK Investigational Site
    Kiel, Schleswig-Holstein 24143, Germany
  • GSK Investigational Site
    Wedel, Schleswig-Holstein 22880, Germany
  • GSK Investigational Site
    Berlin, 10787, Germany
  • GSK Investigational Site
    Berlin, 14057, Germany
  • GSK Investigational Site
    Eisleben, 06295, Germany
  • GSK Investigational Site
    Argos, 21200, Greece
  • GSK Investigational Site
    Athens, 115 22, Greece
  • GSK Investigational Site
    Athens, 11521, Greece
  • GSK Investigational Site
    Athens, 11522, Greece
  • GSK Investigational Site
    Athens, 11527, Greece
  • GSK Investigational Site
    Larisa, 41110, Greece
  • GSK Investigational Site
    Budapest, 1032, Hungary
  • GSK Investigational Site
    Budapest, 1074, Hungary
  • GSK Investigational Site
    Budapest, 1204, Hungary
  • GSK Investigational Site
    Debrecen, 4043, Hungary
  • GSK Investigational Site
    Miskolc, 3526, Hungary
  • GSK Investigational Site
    Nyíregyháza, 4400, Hungary
  • GSK Investigational Site
    Szentes, 6600, Hungary
  • GSK Investigational Site
    Almere, 1311RL, Netherlands
  • GSK Investigational Site
    Beek, 6191 JW, Netherlands
  • GSK Investigational Site
    Doetinchem, 7009 BL, Netherlands
  • GSK Investigational Site
    EDE, 6716 RP, Netherlands
  • GSK Investigational Site
    Eindhoven, 5623 EJ, Netherlands
  • GSK Investigational Site
    Sneek, 8601 ZK, Netherlands
  • GSK Investigational Site
    Utrecht, 3511 NH, Netherlands
  • GSK Investigational Site
    Winterswijk, 7101 BN, Netherlands
  • GSK Investigational Site
    Alcazar De San Juan (Ciudad Real), 13600, Spain
  • GSK Investigational Site
    Barcelona, 08006, Spain
  • GSK Investigational Site
    Bormujo (Sevilla), 41930, Spain
  • GSK Investigational Site
    Cadiz, 11009, Spain
  • GSK Investigational Site
    Coslada, 28822, Spain
  • GSK Investigational Site
    Getafe/Madrid, 28905, Spain
  • GSK Investigational Site
    Granada, 18012, Spain
  • GSK Investigational Site
    Guadalajara, 19002, Spain
  • GSK Investigational Site
    Madrid, 28007, Spain
  • GSK Investigational Site
    Madrid, 28031, Spain
  • GSK Investigational Site
    Madrid, 28040, Spain
  • GSK Investigational Site
    Marbella, 29600, Spain
  • GSK Investigational Site
    Mendaro, Guipuzcoa, 20850, Spain
  • GSK Investigational Site
    Murcia, 30008, Spain
  • GSK Investigational Site
    Toledo, 45004, Spain
  • GSK Investigational Site
    Vitoria- Gasteiz, 01009, Spain
09

References and documents

Publications

  • Roehrborn CG, Manyak MJ, Palacios-Moreno JM, Wilson TH, Roos EPM, Santos JC, Karanastasis D, Plastino J, Giuliano F, Rosen RC. 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 Apr;121(4):647-658. doi: 10.1111/bju.14057. Epub 2017 Nov 16. PubMed 29044968 ↗

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01777269
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jan 28, 2013
Start date
Feb 18, 2013
Primary completion
Apr 5, 2016
Completion
Apr 5, 2016
Results posted
Jul 14, 2017
Last update
Aug 20, 2018

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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