Last updated: 08/06/2025 09:20:08

A study to monitor safety and effectiveness of Duodart in Korean participants with benign prostatic hyperplasia (BPH)

GSK study ID
214234
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of Duodart administered in Korean subjects for treatment of BPH in real-world practice
Trial description: This study will perform an active post-marketing surveillance (PMS) by collecting data on safety and effectiveness of dutasteride/tamsulosin (DUODART) in Korean participants with lower urinary tract symptoms (LUTS)/BPH. DUODART is a registered trademark of the GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with non-serious adverse events (NSAEs)

Timeframe: Up to 57 months

Number of participants with non-serious adverse drug reactions (NSADRs)

Timeframe: Up to 57 months

Number of participants with unexpected AEs

Timeframe: Up to 57 months

Number of participants with unexpected ADRs

Timeframe: Up to 57 months

Number of participants with serious AEs (SAEs)

Timeframe: Up to 57 months

Number of participants with serious ADRs (SADRs)

Timeframe: Up to 57 months

Secondary outcomes:

Change from Baseline in Physician's Global Assessment (PGA) based on International Prostate Symptom Score (IPSS) scores

Timeframe: Baseline and at 6 months

Interventions:
Not applicable
Enrollment:
720
Primary completion date:
2025-24-07
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Prostatic Hyperplasia
Product
dutasteride, dutasteride/tamsulosin, tamsulosin
Collaborators
Not applicable
Study date(s)
June 2022 to July 2025
Type
Observational
Phase
4

Participation criteria

Sex
Male
Age
18+ years
Accepts healthy volunteers
No
  • Adult
  • Treatment of moderate to severe symptoms of BPH.
  • Women
  • Pediatrics under 18 years old
Inclusion and exclusion criteria
Inclusion criteria:
  • Adult
  • Treatment of moderate to severe symptoms of BPH.
Exclusion criteria:
  • Women
  • Pediatrics under 18 years old
  • Participants with a history of orthostatic hypotension
  • Participants with severe renal impairment
  • Participants with known hypersensitivity to dutasteride, other 5 alpha-reductase inhibitors, tamsulosin hydrochloride or any component of the dutasteride/tamsulosin fixed drug combination.

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
Cheonan-si, South Korea, 31151
Status
Study Complete
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Location
GSK Investigational Site
Daegu, South Korea, 700-721
Status
Study Complete
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Location
GSK Investigational Site
Gwangju, South Korea, 61469
Status
Study Complete
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Location
GSK Investigational Site
Gyeonggi-do, South Korea, 445-170
Status
Study Complete
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Location
GSK Investigational Site
Incheon, South Korea, 21565
Status
Study Complete
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Location
GSK Investigational Site
Seoul, South Korea, 03722
Status
Study Complete
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Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Study complete
Actual primary completion date
2025-24-07
Actual study completion date
2025-24-07

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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