Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study

This study has been completed.
Sponsor:
Information provided by:
Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00427882
First received: January 25, 2007
Last updated: November 28, 2007
Last verified: November 2007

January 25, 2007
November 28, 2007
September 2006
Not Provided
Mean change from baseline to the end of treatment in the MSHQ ejaculation total score
Same as current
Complete list of historical versions of study NCT00427882 on ClinicalTrials.gov Archive Site
  • Mean change from baseline to 4 weeks in MSHQ ejaculation total score
  • Mean change from baseline to 4 weeks and the end of treatment in MSHQ erection total score and in the satisfaction total score
  • Mean change from baseline to 4 weeks and the end of treatment in MSHQ ejaculation questions, in the erection and satisfaction sub-scores
  • 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
  • Mean change from baseline to 4 weeks and the end of treatment in I-PSS sub-scores for voiding, filling and nocturia symptoms
  • Mean change from baseline to 4 weeks and the end of treatment in the peak urinary flow rate (Qmax)
  • Correlation between MSHQ and IPSS
  • Evaluation of adverse events, vital signs (blood pressure and heart rate in sitting position), PSA (Prostate Specific Antigen) and creatinine.
Same as current
Not Provided
Not Provided
 
Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study
An Open, Non-Comparative, Multicenter Study on the Sexual Function Improvement Following Treatment With Alfuzosin in Patients With Benign Prostate Hyperplasia

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostatic Hyperplasia
Drug: ALFUZOSIN
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
May 2007
Not Provided

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.

Male
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00427882
ALFUS_L_01778
Not Provided
Not Provided
Handok Pharmaceuticals Co., Ltd.
Not Provided
Study Director: Hyou-Young Rhim, Dr. Handok Pharmaceuticals Co., Ltd.
Handok Pharmaceuticals Co., Ltd.
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP