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OpenTrials
Completed

NCT Number: NCT00427882

Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study

Primary:

To assess improvement in ejaculation from baseline to the end of treatment (Week 12 or premature withdrawal) with Alfuzosin 10mg OD, using MSHQ score.

Secondary:

* To evaluate sexual function improvement * To evaluate LUTS (Lower Uninary Tract Symptoms) improvement * To evaluate the association between LUTS severity and sexual function. * To assess the safety and the tolerability of Alfuzosin 10mg OD.

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Handok

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH) diagnosed by the Investigator
  • Patients with an I-PSS total score ≥ 8
  • Patients sexually active as defined by at least one of the following activities in the last 4 weeks: intercourse, caressing, foreplay, masturbation

Exclusion criteria

  • Patients with a known history of hepatic or severe renal insufficiency, unstable angina pectoris
  • Patients who had a previous prostate surgery
  • Patients who had a prostate biopsy or minimally invasive procedure within 6 months prior to inclusion
  • Patients with a prostate surgery or minimally invasive procedure during the whole study period
  • Patients with an active urinary tract infection or prostatitis
  • Patients with a neuropathic bladder defined as a spinal injury consequence or related to a neurological disorder or a known residual volume ≥ 350 ml
  • Patients with a diagnosed prostate cancer
  • Patients having received 5a-reductase inhibitors or LUTS related-phytotherapy within 6 months prior to inclusion, or a1-blockers within 30 days prior to inclusion
  • Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion
  • Patients with a history of postural hypotension or syncope
  • Patients with a known hypersensitivity to alfuzosin

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Alfuzosin

Drug

Primary outcomes

  1. Mean change from baseline to the end of treatment in the MSHQ ejaculation total score

Secondary outcomes

  1. Mean change from baseline to 4 weeks in MSHQ ejaculation total score

  2. Mean change from baseline to 4 weeks and the end of treatment in MSHQ erection total score and in the satisfaction total score

  3. Mean change from baseline to 4 weeks and the end of treatment in MSHQ ejaculation questions, in the erection and satisfaction sub-scores

  4. Mean change from baseline to 4 weeks and the end of treatment in the I-PSS (International Prostate Symptom Score) total score and in the Quality of Life

  5. Mean change from baseline to 4 weeks and the end of treatment in I-PSS sub-scores for voiding, filling and nocturia symptoms

  6. Mean change from baseline to 4 weeks and the end of treatment in the peak urinary flow rate (Qmax)

  7. Correlation between MSHQ and IPSS

  8. Evaluation of adverse events, vital signs (blood pressure and heart rate in sitting position), PSA (Prostate Specific Antigen) and creatinine.

Sponsors and collaborators

Lead sponsor

Handok Inc.

Industry

Registry information

Official study title

An Open, Non-Comparative, Multicenter Study on the Sexual Function Improvement Following Treatment With Alfuzosin in Patients With Benign Prostate Hyperplasia

Important dates

Study start
2006
Study completion
2007
First posted
Jan 29, 2007
Registry last updated
Nov 29, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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