Study FDC114615: Comparative efficacy of DuodartTM plus lifestyle advice versus watchful waiting plus lifestyle advice with step-up therapy to tamsulosin in the management of treatment naïve men with moderately symptomatic benign prostatic hyperplasia and prostate enlargement.

Phase 4

Completed

• Conditions: benign prostate hyperplasia; 10046590; prostate symptoms

• Registration Number: NL-OMON38047
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

* Males aged *50 years with confirmed clinical diagnosis of BPH.
* International Prostate Symptom Score (IPSS) 8*19.
* Prostate volume *30 cc (TRUS).
* PSA *1.5 ng/mL.
* Men with a female partner of childbearing potential must agree to use effective contraception.

Exclusion Criteria

* Total serum PSA >10.0 ng/mL.
* History or evidence of prostate cancer.
* Current or any prior use of the following prohibited medications
o a 5*-reductase inhibitor,
o anti-cholinergics,
o an alpha-adrenoreceptor blocker for BPH or LUTS.
* any drugs with anti-androgenic properties within the previous 6 months.
* any drugs noted for gynaecomastia effects, or could affect prostate volume, within 6 months of the Visit 1.
* Use of phytotherapy for BPH within 2 weeks prior to Visit 1.
* Previous prostate surgery.
* Instrumentation of the urethra within 7 days prior to Visit 1 (screening). Catheterisation (<10F) is acceptable with no time restriction.
* History of AUR within 3 months prior to Visit 1.
* Post-void residual volume >250 mL
* 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.
* History of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>BPH symptoms.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Questionnaires, progression, surgery, adverse effects.</p><br>