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
  Purpose

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.

Condition Intervention Phase
Prostatic Hyperplasia
Drug: ALFUZOSIN
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Non-Comparative, Multicenter Study on the Sexual Function Improvement Following Treatment With Alfuzosin in Patients With Benign Prostate Hyperplasia

Resource links provided by NLM:


Further study details as provided by Handok Pharmaceuticals Co., Ltd.:

Primary Outcome Measures:
  • Mean change from baseline to the end of treatment in the MSHQ ejaculation total score

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 125
Study Start Date: September 2006
Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427882

Locations
Korea, Republic of
Handok
Seoul, Korea, Republic of
Sponsors and Collaborators
Handok Pharmaceuticals Co., Ltd.
Investigators
Study Director: Hyou-Young Rhim, Dr. Handok Pharmaceuticals Co., Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00427882     History of Changes
Other Study ID Numbers: ALFUS_L_01778
Study First Received: January 25, 2007
Last Updated: November 28, 2007
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Alfuzosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014