SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

Prostatic Hyperplasia Clinical Trial

Official title:

Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL OD 10mg), Open, 24-week Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486785
• Other study ID #: ALFUS_L_01667
• Status: Completed
• Phase: Phase 4
• First received: June 14, 2007
• Last updated: September 29, 2009
• Start date: April 2006
• Est. completion date: March 2008

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

• To assess the sexual function improvement from baseline to the end of treatment (Week 24 or premature withdrawal (PW)) with XATRAL 10mg OD.

Secondary Objective:

• To evaluate the association between Lower Urinary Tract Symptoms (LUTS) severity and sexual disorders,

• To compare the improvement in sexual function, urinary symptoms and Quality of Life among the different regions,

• To correlate MSHQ (Male Sexual Health Questionnaire) and IIEF-5 (the 5-Item version of the International Index of Erectile Function),

• To assess the onset of action of XATRAL 10mg OD,

• To assess the peak flow rate improvement (Qmax),

• To assess the safety and the tolerability of XATRAL 10mg OD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 431
• Est. completion date: March 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH),

• Patients with an I-PSS total score = 8,

• Patients sexually active

Exclusion Criteria:

• Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant threatening-life condition.

• Previous prostate surgery, minimally invasive procedure within 6 months prior to inclusion. Planned prostate biopsy, prostate surgery or minimally invasive procedure during the whole study period.

• Active urinary tract infection or prostatitis, neuropathic bladder, 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.

• History of postural hypotension or syncope.

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Alfuzosin
Alfuzosin 10mg Once Daily for 24 weeks

Locations

Country	Name	City	State
Colombia	Sanofi-Aventis	Bogota
Ecuador	Sanofi-Aventis	Quito
Guatemala	Sanofi-Aventis	Guatemala City
Mexico	Sanofi-Aventis	Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Colombia,  Ecuador,  Guatemala,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline to the end of treatment in the Male Sexual Health Questionnaire(MSHQ) for sexual function.		24 weeks	No
Primary	Evaluation of adverse events, vital signs (blood pressure and heart rate), PSA (Prostate-specific antigen; mandatory at baseline and optional at the end of treatment) and serum creatinine assessment (optional at baseline and at the end of treatment)		24 weeks	No
Secondary	- Mean change from baseline to 4, 12, and 24 weeks of treatment in MSHQ in the ejaculation score - Mean change from baseline to 4, 12 and 24 weeks of treatment in MSHQ ejaculation questions, in the erection questions and sexual activity and desire		24 weeks	No
Secondary	- Mean change from baseline to week 1 in I-PSS total score and sub-scores (objective onset of action) - Onset of action based on patient perception (questionnaire at Week 1)		24 weeks	No
Secondary	-Mean change from baseline to 4,12 and 24 weeks of treatment in the I-PSS total score and in the Quality of Life -QOL Mean change from baseline to 4, 12 and 24 weeks of treatment in the I-PSS total score and in the Quality of Life		24 weeks	No