Prospective Sexual Function Study for BPH Subjects

NCT01777269 | Completed Phase 4 Results

• 2 other identifiers: 1161152012-002047-26
• Study Type: interventional
• Target: 489
• Locations: 7 countries
• Sites: 67

Brief 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 .

Conditions

Prostatic Hyperplasia

Outcome Measures

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)

  Baseline and 12 months

Secondary Outcomes (10)

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

  Baseline and Month 1, 3, 6, and 9

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

  Baseline and 12 months

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

  Baseline and Month 1, 3, 6, 9 and 12

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

  Baseline and Month 1, 3, 6, 9 and 12

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

  Baseline and Month 1, 3, 6, 9 and 12

Study Arms (2)

Duodart

EXPERIMENTAL

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

Drug: Dutasteride plus tamsulosin

Sugar Pill

PLACEBO COMPARATOR

A capsule once daily during 12 months

Drug: Placebo

Interventions

Dutasteride plus tamsulosin DRUG

Take 1 capsule daily

Duodart

Placebo DRUG

Take one capsule daily

Sugar Pill

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (67)

GSK Investigational Site

Randwick, New South Wales, 2031, Australia

Location

GSK Investigational Site

Sydney, New South Wales, 2000, Australia

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GSK Investigational Site

Wahroonga, New South Wales, 2076, Australia

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GSK Investigational Site

Herston, Queensland, 4029, Australia

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GSK Investigational Site

Kippa-Ring, Queensland, 4021, Australia

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GSK Investigational Site

Adelaide, South Australia, 5000, Australia

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GSK Investigational Site

Heidelberg, Victoria, 3084, Australia

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GSK Investigational Site

Malvern, Victoria, 3144, Australia

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GSK Investigational Site

Garches, 92380, France

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GSK Investigational Site

Nantes, 44277, France

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GSK Investigational Site

Nîmes, 30029, France

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GSK Investigational Site

Orléans, 45100, France

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GSK Investigational Site

Paris, 75651, France

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GSK Investigational Site

Thouars, 79100, France

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GSK Investigational Site

Nuremberg, Bavaria, 90441, Germany

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GSK Investigational Site

Hagenow, Brandenburg, 19230, Germany

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GSK Investigational Site

Oranienburg, Brandenburg, 16515, Germany

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GSK Investigational Site

Strausberg, Brandenburg, 15344, Germany

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GSK Investigational Site

Marburg, Hesse, 35039, Germany

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GSK Investigational Site

Buchholz, Lower Saxony, 21244, Germany

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GSK Investigational Site

Aachen, North Rhine-Westphalia, 52064, Germany

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GSK Investigational Site

Dortmund, North Rhine-Westphalia, 44225, Germany

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GSK Investigational Site

Dülmen, North Rhine-Westphalia, 48249, Germany

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GSK Investigational Site

Leipzig, Saxony, 04109, Germany

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GSK Investigational Site

Hettstedt, Saxony-Anhalt, 06333, Germany

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GSK Investigational Site

Kiel, Schleswig-Holstein, 24143, Germany

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GSK Investigational Site

Wedel, Schleswig-Holstein, 22880, Germany

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GSK Investigational Site

Berlin, 10787, Germany

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GSK Investigational Site

Berlin, 14057, Germany

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GSK Investigational Site

Eisleben Lutherstadt, 06295, Germany

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GSK Investigational Site

Argos, 21200, Greece

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GSK Investigational Site

Athens, 115 22, Greece

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GSK Investigational Site

Athens, 11521, Greece

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GSK Investigational Site

Athens, 11522, Greece

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GSK Investigational Site

Athens, 11527, Greece

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GSK Investigational Site

Larissa, 41110, Greece

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GSK Investigational Site

Budapest, 1032, Hungary

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GSK Investigational Site

Budapest, 1074, Hungary

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GSK Investigational Site

Budapest, 1204, Hungary

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GSK Investigational Site

Debrecen, 4043, Hungary

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GSK Investigational Site

Miskolc, 3526, Hungary

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GSK Investigational Site

Nyíregyháza, 4400, Hungary

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GSK Investigational Site

Szentes, 6600, Hungary

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GSK Investigational Site

Almere Stad, 1311RL, Netherlands

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GSK Investigational Site

Beek, 6191 JW, Netherlands

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GSK Investigational Site

Doetinchem, 7009 BL, Netherlands

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GSK Investigational Site

Ede, 6716 RP, Netherlands

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GSK Investigational Site

Eindhoven, 5623 EJ, Netherlands

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GSK Investigational Site

Sneek, 8601 ZK, Netherlands

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GSK Investigational Site

Utrecht, 3511 NH, Netherlands

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GSK Investigational Site

Winterswijk, 7101 BN, Netherlands

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GSK Investigational Site

Alcazar de San Juan (Ciudad Real), 13600, Spain

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GSK Investigational Site

Barcelona, 08006, Spain

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GSK Investigational Site

Bormujo (Sevilla), 41930, Spain

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GSK Investigational Site

Cadiz, 11009, Spain

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GSK Investigational Site

Coslada, 28822, Spain

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GSK Investigational Site

Getafe/Madrid, 28905, Spain

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GSK Investigational Site

Granada, 18012, Spain

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GSK Investigational Site

Guadalajara, 19002, Spain

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GSK Investigational Site

Madrid, 28007, Spain

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GSK Investigational Site

Madrid, 28031, Spain

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GSK Investigational Site

Madrid, 28040, Spain

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GSK Investigational Site

Marbella, 29600, Spain

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GSK Investigational Site

Mendaro, Guipuzcoa, 20850, Spain

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GSK Investigational Site

Murcia, 30008, Spain

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GSK Investigational Site

Toledo, 45004, Spain

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GSK Investigational Site

Vitoria-Gasteiz, 01009, Spain

Location

Related Publications (1)

• 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.

  PMID: 29044968 DERIVED

Related Links

• IPD for this study will be made available via the Clinical Study Data Request site.

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Dutasteride; Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 28, 2013
• Study Start: February 18, 2013
• Primary Completion: April 5, 2016
• Study Completion: April 5, 2016
• Last Updated: August 20, 2018
• Results First Posted: July 14, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

GR (6); AU (8); NL (8); ES (16); FR (6); DE (16); HU (7)