FDC116115: A prospective study of sexual function in sexually active men treated for BPH

Overview

No summary available.

Registry

who.int

Start Date

September 11, 2012

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•1\. Males aged \=50 years.
•2\. Men must be sexually active.
•3\. A confirmed clinical diagnosis of BPH.
•4\. International Prostate Symptom Score (IPSS) \> or \= 12 at Visit 1 (screening), with bother score 4 or less (score from the IPSS Quality of Life question 8\).
•5\. Prostate volume \=30 cc (by transrectal ultrasonography; TRUS). Measurement should be available by the baseline visit and should have been made /arranged at the screening visit or within the previous 6 months.
•6\. Total serum prostate specific antigen (PSA) \=1\.5 ng/mL (but see exclusion criteria 1\) at Visit 1 (screening).
•7\. Willing and able to give signed written informed consent and comply with study procedures, including the ability to participate in the study for the full 1 year (or 18 months if necessary because of a persistent sexual AE).
•8\. Fluent and literate in local language with the ability to read, comprehend and record information on the MSHQ, IPSS, PPSM, BPH Impact Index (BII) and C\-SSRS questionnaires.
•9\. Able to swallow and retain oral medication.
•10\. Men with a female partner of childbearing potential must either agree to use effective contraception or have had a prior vasectomy. Contraception must be used from 2 weeks prior to administration of the first dose of study treatment until at least 5 half\-lives for the drug (45 days) plus 3 months (i.e. a total of 4\.5 months) to allow clearance of any altered sperm after the last dose of study treatment.

•1\. Total serum PSA \>10\.0 ng/mL at Visit 1 (screening).
•2\. History or evidence of prostate cancer. Subjects with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study.
•3\. Current or prior use (within the periods given) of the following prohibited medications
•i. Any prior use of a 5a\-reductase inhibitor (finasteride or dutasteride),
•ii. Anti\-cholinergics (e.g. oxybutynin, propantheline, tolerodine, solifenacin or darifenacin) within 1 month prior to visit 2 (baseline)
•iii. An alpha\-adrenoreceptor blocker (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 1 month prior to visit 2 (baseline)
•iv. Use of any drugs with anti\-androgenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents) within the 6 months prior to visit 1 (screening).
•v. Use of any drugs noted for propensity to cause gynaecomastia, or which could affect prostate volume, within 6 months prior to Visit 1 (screening).
•vi. Use of any investigational or marketed study drug within 30 days or 5 half\-lives of the drug in question, (whichever is longer), preceding visit 2 (baseline).
•4\. Current use (at the baseline visit or within the prior 1month) of: PDE\-5 inhibitors, Anabolic steroids, Drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin.