A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effect of Tadalafil Once Daily for 8 Weeks on Prostatic Blood Flow and Perfusion Parameters in Men with Signs and Symptoms of Benign Prostatic Hyperplasia - LVIR
- Conditions
- Benign Prostatic Hyperplasia (BPH)MedDRA version: 12.1Level: LLTClassification code 10004446Term: Benign prostatic hyperplasia
- Registration Number
- EUCTR2010-020220-22-AT
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 106
Subjects are eligible to be included in the study only if they meet all of the following criteria:
[1] Present with benign prostatic hyperplasia (BPH; also referred to as BPH-LUTS [lower urinary tract symptoms]) based on the disease diagnostic criteria at screening.
[2] Are men 45 years of age or older at screening.
[3] Provide signed informed consent at screening.
[4] Agree not to use any other approved or experimental pharmacologic BPH, overactive bladder (OAB), or erectile dysfunction (ED) treatments, including alpha blockers, 5-alpha reductase inhibitors (5-ARIs), antimuscarinics, phosphodiesterase type 5 (PDE5) inhibitors, or herbal preparations at any time during the study.
[5] Have not taken the following treatments within the indicated duration:
• Finasteride therapy for at least 3 months prior to the TRUS assessment period.
• Dutasteride therapy for at least 6 months prior to the TRUS assessment period.
• All other BPH therapy (including herbal preparations and vitamin preparations containing saw palmetto) for at least 4 weeks prior to the TRUS assessment period.
• Overactive bladder therapy for at least 4 weeks prior to the TRUS assessment period.
• ED therapy for at least 4 weeks prior to the TRUS assessment period.
• Any other experimental or off-label BPH therapy, such as injectable therapies with a protracted effect, for at least 6 months prior to the TRUS assessment period.
[6] Have LUTS with a total IPSS =13 under 1 of the following conditions:
• At screening if the subject does not require wash-out of therapy for BPH-LUTS.
• At the start of the TRUS assessment period if the subject requires wash-out (4 weeks) of BPH-LUTS therapy.
[7] Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of =4 to =15 mL/second (from a prevoid total bladder volume [assessed by ultrasound] of =150 to =550 mL and a minimum voided volume of 125 mL) under 1 of the following conditions:
• At screening if the subject does not require wash-out of therapy for BPH-LUTS.
• At the start of the TRUS assessment period if the subject requires wash-out (4 weeks) of BPH-LUTS therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
[8] Prostate specific antigen (PSA) >10.0 ng/mL at screening
[9] PSA =4.0 to =10.0 ng/mL at screening if prostate malignancy has not been ruled out to the satisfaction of a urologist
[10] Bladder postvoid residual volume = 300 mL by ultrasound determination at screening
[11] History of any of the following pelvic conditions:
• Pelvic surgery or any other pelvic procedure
• Pelvic radiotherapy
• Any pelvic surgical procedure of the urinary tract
• Lower urinary tract malignancy or trauma
[12] Lower urinary tract instrumentation within 30 days of screening
[13] History of urinary retention or lower urinary tract stones within 6 months of screening
[14] History of urethral obstruction due to stricture, valves, sclerosis, or tumor
[15] Clinical evidence or medical history of any of the following bladder conditions:
• Mullerian duct cysts
• Atonic, decompensated or hypocontractile bladder
• Detrusor-sphincter dyssynergia
• Intravesical obstruction
• Interstitial cystitis
[16] Clinical evidence of any of the following urinary tract conditions at screening:
• Urinary tract infection
• Urinary tract inflammation
• Current antibiotic therapy for urinary tract infection
• Clinically significant microscopic hematuria
[17] Clinical evidence of prostate cancer
[18] History of prostate saturation biopsy
[19] Any condition which may preclude or negatively influence tolerance to TRUS
[20] Clinical evidence on TRUS of any of the following prostate conditions at the start of the TRUS assessment period or other findings related to prostate anatomy on screening TRUS that may interfere with measurement of ultrasound blood flow parameters
• Prominent median or midline lobe
• Multiple prostatic cystic changes or multiple calcifications
• Scarring from previous prostate biopsies
[21] Current neurologic disease or condition associated with neurogenic bladder
[22] History of significant renal insufficiency
[23] Clinical evidence of severe hepatic impairment at screening
[24] History of any of the following cardiac conditions:
• Angina requiring treatment with long-acting nitrates
• Angina requiring treatment with short-acting nitrates within 90 days of screening
• Unstable angina within 90 days of screening
• Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention
[25] History of any of the following coronary conditions within 90 days of screening:
• Myocardial infarction
• Coronary artery bypass graft surgery
• Percutaneous coronary intervention
[26] Any evidence of moderate to severe cardiac disease within 6 months of screening
[27] Systolic blood pressure >160 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at screening (if stress is suspected, retest under basal conditions) or malignant hypertension
[28] Scheduled or planned surgery during the course of the study
[29] History of drug, alcohol, or substance abuse within 6 months of screening
[30] Any condition that would interfere with subject ability to provide informed consent or comply with study instructions, would place subject at increased risk, or might confound the interpretation of the study results
[31] Current treatment with nitrates (as outlined in Exclusion Criterion 24), androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone agonists/antagonists, anabolic steroids, or non-prescription products containing estrogenic or androgenic supplements
[32] Current systemic treatment with any of the following:
• Pote
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method