Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006454

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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 .

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00006454
  •   2015/04/27
  •   2013/01/24
  •   no
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Secondary IDs

  •   2012-002047-26 
  •   NCT01777269  (ClinicalTrials.gov)
  •   116115  (GlaxoSmithKline)
  •   2012-002047-26 
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Health Condition or Problem studied

  •   Prostatic Hyperplasia
  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   Drug: Dutasteride plus tamsulosin
  •   Drug: Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   IV
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Primary Outcome

- Changes in total score from the full men's sexual health questionnaire (MSHQ) which has domains for erectile dysfunction, ejaculatory function and libido.; time frame: 12 months; 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.

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Secondary Outcome

- Change in scores from the full Men's Sexual Health Questionnaire (MSHQ) from baseline at 1, 3, 6 and 9 months; time frame: 1, 3, 6 and 9 months; To assess changes in sexual function from baseline at 1, 3, 6 and 9 months using the full Men's Sexual Health Questionnaire (MSHQ).
- The percentage of subjects reaching the following thresholds: +10 points, +20 points,+25 points, -10 points, -20 points, -25 points, change in total MSHQ from baseline at 12 months; time frame: 12 months; To assess the percentage of subjects reaching various thresholds of change in total MSHQ from baseline at 12 months. Thresholds will include: +10 points, +20 points,+25 points, -10 points, -20 points, -25 points, changes in score
- Change in scores from ED, EjD and libido domains from baseline at 1, 3, 6, 9 and 12 months.; time frame: 1, 3, 6 , 9 and 12 months; To assess changes from baseline in erectile dysfunction (ED), ejaculatory dysfunction (EjD), and libido domains (of the MSHQ) on DUODART vs placebo at 1, 3, 6, 9 and 12 months.
- Change in scores from baseline IPSS questionnaire scores, Quality of Life (BPH Impact Index -BII scores) and perception of treatment benefit/satisfaction with treatment (PPSM questionnaire scores) at 2 weeks an 1, 3, 6 ,9 and 12 months; time frame: 1, 3, 6 , 9 and 12 months; To assess changes from baseline in BPH symptoms (IPSS questionnaire change in scores), quality of life (BPH Impact Index - BII), perception of treatment benefit/satisfaction with treatment (Patient Perception of Study Medication (PPSM) and relationship of these changes to sexual function
- Change in MSHQ scores from baseline at 12 months in subpopulations of men with good BPH symptomatic response; time frame: 12 months; To assess changes in MSHQ scores from baseline at 12 months in subpopulations of men with good BPH symptomatic response
- Assess the duration of events both during the treatment phase and after treatment discontinuation by following up men with sexual adverse events who withdraw from the study or men with sexual apresent at the last visit of the treatment phase; time frame: 6 months of follow up; To evaluate the persistence (duration) of sexual adverse events occuring during the treatment phase

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Countries of Recruitment

  •   Australia
  •   France
  •   Germany
  •   Greece
  •   Hungary
  •   Netherlands
  •   Spain
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Locations of Recruitment

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Recruitment

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  •   2013/02/27
  •   476
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   50   Years
  •   no maximum age
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Additional 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.

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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.

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Addresses

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    • GlaxoSmithKline
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  • start of 1:1-Block address scientific-contact
    • GlaxoSmithKline
    • GSK Clinical Trials 
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    • US GSK Clinical Trials Call Center 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.