Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study
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|ClinicalTrials.gov Identifier: NCT00427882|
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : November 29, 2007
To assess improvement in ejaculation from baseline to the end of treatment (Week 12 or premature withdrawal) with Alfuzosin 10mg OD, using MSHQ score.
- 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 or disease||Intervention/treatment||Phase|
|Prostatic Hyperplasia||Drug: ALFUZOSIN||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open, Non-Comparative, Multicenter Study on the Sexual Function Improvement Following Treatment With Alfuzosin in Patients With Benign Prostate Hyperplasia|
|Study Start Date :||September 2006|
|Actual Study Completion Date :||May 2007|
- Mean change from baseline to the end of treatment in the MSHQ ejaculation total score
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427882
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Study Director:||Hyou-Young Rhim, Dr.||Handok Pharmaceuticals Co., Ltd.|