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Prostatic HyperplasiaPhase 4NCT01777269

Prospective Sexual Function Study for BPH Subjects

A Phase 4 study testing Dutasteride plus tamsulosin in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 67 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Prostatic Hyperplasia
What is being tested?
Dutasteride plus tamsulosin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
489 participants
Where
67 sitesin 7 countries
Study dates
18 Feb 2013to 5 Apr 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 11Show fewer
  • 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.

Who cannot join

  • 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),
Show all 34Show fewer
  • 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 locations and contacts

67 sites in 7 countries.

67 sites in 7 countries

Germany16 sites

  • GSK Investigational Site

    Aachen, North Rhine-Westphalia, 52064

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 14057

  • GSK Investigational Site

    Buchholz, Lower Saxony, 21244

  • GSK Investigational Site

    Dortmund, North Rhine-Westphalia, 44225

  • GSK Investigational Site

    Dülmen, North Rhine-Westphalia, 48249

  • GSK Investigational Site

    Eisleben Lutherstadt, 06295

  • GSK Investigational Site

    Hagenow, Brandenburg, 19230

  • GSK Investigational Site

    Hettstedt, Saxony-Anhalt, 06333

  • GSK Investigational Site

    Kiel, Schleswig-Holstein, 24143

  • GSK Investigational Site

    Leipzig, Saxony, 04109

  • GSK Investigational Site

    Marburg, Hesse, 35039

  • GSK Investigational Site

    Nuremberg, Bavaria, 90441

  • GSK Investigational Site

    Oranienburg, Brandenburg, 16515

  • GSK Investigational Site

    Strausberg, Brandenburg, 15344

  • GSK Investigational Site

    Wedel, Schleswig-Holstein, 22880

Other trials in Germany

Spain16 sites

  • GSK Investigational Site

    Alcazar de San Juan (Ciudad Real), 13600

  • GSK Investigational Site

    Barcelona, 08006

  • GSK Investigational Site

    Bormujo (Sevilla), 41930

  • GSK Investigational Site

    Cadiz, 11009

  • GSK Investigational Site

    Coslada, 28822

  • GSK Investigational Site

    Getafe/Madrid, 28905

  • GSK Investigational Site

    Granada, 18012

  • GSK Investigational Site

    Guadalajara, 19002

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28031

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Marbella, 29600

  • GSK Investigational Site

    Mendaro, Guipuzcoa, 20850

  • GSK Investigational Site

    Murcia, 30008

  • GSK Investigational Site

    Toledo, 45004

  • GSK Investigational Site

    Vitoria-Gasteiz, 01009

Other trials in Spain

Australia8 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Heidelberg, Victoria, 3084

  • GSK Investigational Site

    Herston, Queensland, 4029

  • GSK Investigational Site

    Kippa-Ring, Queensland, 4021

  • GSK Investigational Site

    Malvern, Victoria, 3144

  • GSK Investigational Site

    Randwick, New South Wales, 2031

  • GSK Investigational Site

    Sydney, New South Wales, 2000

  • GSK Investigational Site

    Wahroonga, New South Wales, 2076

Other trials in Australia

Netherlands8 sites

  • GSK Investigational Site

    Almere Stad, 1311RL

  • GSK Investigational Site

    Beek, 6191 JW

  • GSK Investigational Site

    Doetinchem, 7009 BL

  • GSK Investigational Site

    Ede, 6716 RP

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Sneek, 8601 ZK

  • GSK Investigational Site

    Utrecht, 3511 NH

  • GSK Investigational Site

    Winterswijk, 7101 BN

Other trials in Netherlands

Hungary7 sites

  • GSK Investigational Site

    Budapest, 1032

  • GSK Investigational Site

    Budapest, 1074

  • GSK Investigational Site

    Budapest, 1204

  • GSK Investigational Site

    Debrecen, 4043

  • GSK Investigational Site

    Miskolc, 3526

  • GSK Investigational Site

    Nyíregyháza, 4400

  • GSK Investigational Site

    Szentes, 6600

Other trials in Hungary

France6 sites

  • GSK Investigational Site

    Garches, 92380

  • GSK Investigational Site

    Nantes, 44277

  • GSK Investigational Site

    Nîmes, 30029

  • GSK Investigational Site

    Orléans, 45100

  • GSK Investigational Site

    Paris, 75651

  • GSK Investigational Site

    Thouars, 79100

Other trials in France

Greece6 sites

  • GSK Investigational Site

    Argos, 21200

  • GSK Investigational Site

    Athens, 115 22

  • GSK Investigational Site

    Athens, 11521

  • GSK Investigational Site

    Athens, 11522

  • GSK Investigational Site

    Athens, 11527

  • GSK Investigational Site

    Larissa, 41110

Other trials in Greece

About this study

Official title: A Prospective Study of Sexual Function in Sexually Active Men Treated for BPH

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.

Being tested
Dutasteride plus tamsulosin, Placebo
Medical subject headings
Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dutasteride plus tamsulosinDrug

    Take 1 capsule daily

  • PlaceboDrug

    Take one capsule daily

Study groups in NCT01777269
Study groupRoleWhat they receive
DuodartExperimentalFixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg. A capsule once daily during 12 months
Receives: Drug: Dutasteride plus tamsulosin
Sugar PillPlacebo comparatorA capsule once daily during 12 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Baseline and 12 months

Secondary outcomes (10)

  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)

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: Baseline and Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2013 (estimated)
  2. Study start18 Feb 2013
  3. Primary completion5 Apr 2016
  4. Study completion5 Apr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
489 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01777269
Sponsor's protocol ID
116115
Other IDs
2012-002047-26
Status last verified
Jul 2018
First submitted
24 Jan 2013
Last updated
20 Aug 2018
Data monitoring committee
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dutasteride plus tamsulosin in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 67 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in Germany, Spain, Australia, Netherlands, Hungary and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01777269, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.

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Prospective Sexual Function Study for BPH Subjects | AzTrials