Prospective Sexual Function Study for BPH Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01777269
First received: January 24, 2013
Last updated: July 24, 2014
Last verified: June 2014
  Purpose

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 .


Condition Intervention Phase
Prostatic Hyperplasia
Drug: Dutasteride plus tamsulosin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Study of Sexual Function in Sexually Active Men Treated for BPH

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    To evaluate the persistence (duration) of sexual adverse events occuring during the treatment phase


Estimated Enrollment: 476
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Duodart
Fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg. A capsule once daily during 12 months
Drug: Dutasteride plus tamsulosin
Take 1 capsule daily
Placebo Comparator: Sugar Pill
A capsule once daily during 12 months
Drug: Placebo
Take one capsule daily

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males aged ≥50 years.
  • Men must be sexually active. A man is considered sexually active if he has been engaged in sexual activity with a partner during the past 4 weeks (at least once) and plans to be active during the next 4 weeks (unless due to travel or other practical reasons). Men should confirm that they are in a stable relationship and expect to maintain their sexual activity over the next year.
  • A confirmed clinical diagnosis of BPH.
  • International Prostate Symptom Score (IPSS) ≥12 at Visit 1 (screening), with bother score 4 or less (score from the IPSS Quality of Life question 8).
  • Prostate volume ≥30 cc (by transrectal ultrasonography; TRUS). Measurement should be available by the baseline visit and should have been made /arranged at the screening visit or within the previous 6 months.
  • Total serum prostate specific antigen (PSA ≥1.5 ng/mL (see exclusion criteria 1) at Visit 1 (screening).
  • Willing and able to give signed written informed consent and comply with study procedures, including the ability to participate in the study for the full 1 year (or 18 months if necessary because of a persistent sexual AE).
  • Fluent and literate in local language with the ability to read, comprehend and record information on the MSHQ, IPSS, PPSM, BPH Impact Index (BII) and C-SSRS questionnaires.
  • Able to swallow and retain oral medication.
  • Men with a female partner of childbearing potential must either agree to use effective contraception or have had a prior vasectomy. Contraception must be used from 2 weeks prior to administration of the first dose of study treatment until at least 5 half-lives for the drug (45 days) plus 3 months (i.e. a total of 4.5 months) to allow clearance of any altered sperm after the last dose of study treatment.
  • French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

  • Total serum PSA >10.0 ng/mL at Visit 1 (screening).
  • History or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE and/or rising PSA). Subjects with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study.

Note: If total serum PSA is >4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, including consideration of prostate biopsy.

Excluded medication and therapies

  • Current or prior use (within the periods given) of the following prohibited medications
  • Any prior use of a 5α-reductase inhibitor (finasteride or dutasteride),
  • Anti-cholinergics (e.g. oxybutynin, propantheline, tolerodine, solifenacin or darifenacin) within 1 month prior to visit 2 (baseline)
  • An alpha-adrenoreceptor blocker (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 1 month prior to visit 2 (baseline)
  • Use of any drugs with anti-androgenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents) within the 6 months prior to visit 1 (screening).
  • Use of any drugs noted for propensity to cause gynaecomastia, or which could affect prostate volume, within 6 months prior to Visit 1 (screening).
  • Use of any investigational or marketed study drug within 30 days or 5 half-lives of the drug in question, (whichever is longer), preceding visit 2 (baseline).
  • Current use (at the baseline visit or within the prior 1month) of:
  • PDE-5 inhibitors for Erectile Dysfunction.
  • Anabolic steroids.
  • Drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin.
  • Use of phytotherapy for BPH within 2 weeks prior to Visit 1 (screening) and/or predicted to need phytotherapy during the study.
  • History of a known (immediate or delayed) hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to the study medication or excipients that, in the opinion of the Investigator or GSK, contraindicate their participation.
  • Previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive or minimally invasive procedures to treat BPH.

Recent Medical Procedures

- History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to Visit 1 (screening). Catheterisation (<10F) is acceptable with no time restriction.

Medical history

  • Presence of structural abnormalities in the Lower Urinary Tract or sexual organs (e.g. urethral stricture, Peyronie's Disease etc) that may cause LUTS or sexual dysfunction.
  • History of AUR.
  • Post-void residual volume >100 mL (suprapubic ultrasound) at Visit 1 (screening) or a recorded PVR above this level on any previous examination. Measurement should be available by the baseline visit and should have been made /arranged at the screening visit or within the previous 6 months.
  • Any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections).
  • History of 'first dose' hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy.
  • History of postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury.
  • History of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy.
  • Prior history of malignancies (other than basal cell carcinoma or squamous cell carcinoma of the skin) within the past 5 years. Subjects with an earlier history of malignancy who have had no evidence of disease for at least the past 5 years are eligible.
  • History of hepatic impairment or abnormal liver function tests at Visit 1 (screening) (defined as ALT, AST or alkaline phosphatase >2 times the ULN, or total bilirubin >1.5 times the ULN (unless associated with predominantly indirect bilirubin elevation or Gilbert's syndrome).
  • History of renal insufficiency, or serum creatinine >1.5 times the upper limit of normal at Visit 1 (screening).
  • Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to the Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
  • History or current evidence of drug or alcohol abuse within the previous 12 months.
  • History or presence of any serious and/or unstable pre-existing psychiatric disorder or other conditions that in the opinion of the Investigator or GSK Medical Monitor, could interfere with subject's safety, obtaining informed consent, compliance to the study procedures, or confound the results of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777269

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 67 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01777269     History of Changes
Other Study ID Numbers: 116115, 2012-002047-26
Study First Received: January 24, 2013
Last Updated: July 24, 2014
Health Authority: Spain: Agencia Espanola de Medicamentos y Productos Sanitarios
Australia: Human Research Ethics Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Netherlands: Centrale Commissie Mensgebonden Onderzoek
Hungary: Országos Gyógyszerészeti Intézet
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
Greece: National Drug Organisation

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Tamsulosin
Dutasteride
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses
5-alpha Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014