None listed
Conditions
Brief summary
Tamsulosin is currently prescribed for the symptoms associated with a condition known as benign prostatic hyperplasia. In lay terms this is known as an enlarged prostate (benign). This condition is common in men over the age of 70. The condition can become symptomatic (meaning that symptoms appear) with urinary tract infections and signs of obstruction (of the urine pathway) reported. Symptoms are reported in about 10-30% of men aged in the early 70s. Tamsulosin is currently prescribed for these symptoms. An oral capsule containing tamsulosin has been approved in Australia and other countries and has been on the Australian market for several years. The tablet is taken daily by patients. The current study will test the safety and effectiveness of administering tamsulosin by an alternative method – a patch will be applied once to the skin and is designed to provide 7 days of doses. This patch is called a transdermal delivery system (TDS).
Interventions
7 day wearing of a Tamsulosin Transdermal Delivery System designed to deliver drug continuously for 7 days. The delivery rate is estimated to be 0.4 mg/day.
Sponsors
Corium International, Inc.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
healthy male volunteers aged 18-40 normal findings in ECG and physical exam normal clinical laboratory values
Exclusion criteria
allergy or intolerance to tamsulosin orthostatic hypotension history of alcohol or drug abuse prescription or OTC drug use in 2 weeks prior to screening hemoglobin less than 130 gm/mL
Outcome results
None listed