Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment (NCT00090103) | Clinical Trial Compass
CompletedPhase 3
Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment
United States, Argentina, Belgium4,844 participantsStarted 2003-11
Plain-language summary
This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.
Who can participate
Age range
50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
* males, aged ≥50 years
* clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE)
* International Prostate Symptom Score (IPSS) ≥12 points at Screening
* prostate volume ≥30 cc by transrectal ultrasonography; (TRUS)
* total serum Prostate Specific Antigen (PSA) ≥1.5ng/mL at Screening
* maximum flow rate (Qmax) \>5 mL/sec and ≤15 mL/sec and minimum voided volume of ≥125 mL at Screening (based on two voids)
* willing and able to give written informed consent and comply with study procedures
* fluent and literate in local language with the ability to read, comprehend and record information on the IPSS, BII and Patient Perception of Study Medication
* able to swallow and retain oral medication
* willing and able to participate in the study for the full 4 years.
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
* total serum PSA \>10.0ng/mL at Screening
* history or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE). Patients with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study.
Note: If total serum PSA is \>4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.
Timeframe: Years 1, 2, 3, and 4
2
Number of Participants With AUR or BPH-related Surgery