Prospective Sexual Function Study for BPH Subjects

Status Completed

Clinical 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.

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 .

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01777269
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 4
Start date	February 18, 2013
Completion date	April 5, 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02578953` - Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects	Phase 1
Terminated	`NCT02396420` - Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams	Phase 2
Terminated	`NCT04398966` - Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia	N/A
Not yet recruiting	`NCT06452927` - EEP in Patients With Urodynamically Proven DU/DA	N/A
Completed	`NCT02947958` - Teleconsultation in Counter-reference Between Tertiary and Primary Care for Patients With Benign Prostatic Hyperplasia	N/A
Completed	`NCT01937871` - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)	Phase 3
Completed	`NCT00427882` - Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study	Phase 4
Completed	`NCT02244320` - Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)	N/A
Completed	`NCT01254071` - A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry.	Phase 1
Recruiting	`NCT04108871` - Whether Transperineal Prostate Biopsy Under Local-anaesthesia Using a Transperineal-access System is Non-inferior to Standard Transrectal Biopsy to Detect Prostate Cancer in Biopsy-naïve Men	N/A
Recruiting	`NCT05686525` - Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men With BPH	N/A
Completed	`NCT01957189` - This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples	Phase 1
Completed	`NCT00316732` - Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS	N/A
Completed	`NCT02715401` - PK and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 Under Fed Condition in Healthy Male Volunteers	Phase 1
Recruiting	`NCT02278679` - Digital Rectal Exam Proficiency Tool	N/A
Completed	`NCT01482676` - The Role of microRNAs in Organ Remodeling in Lower Urinary Tract Dysfunction	N/A
Completed	`NCT01376258` - Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database	N/A
Completed	`NCT00822952` - Prostate Mechanical Imager (PMI) Clinical Bridging Study	N/A
Completed	`NCT00527605` - Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)	Phase 3
Terminated	`NCT00563485` - Randomized Trial Comparing Terazosin 5 mg Daily and Doxazosin GITS 4 mg Daily for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up	N/A