A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia. - A Study in Benign Prostatic Hyperplasia

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2009-010739-42-FR
• Date of registration: 05/10/2009
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia. - A Study in Benign Prostatic Hyperplasia
• Scientific title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia. - A Study in Benign Prostatic Hyperplasia
• Date of first enrolment: 20/11/2009
• Target sample size: 453
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010739-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, France, Germany, Greece, Italy, Netherlands

Key inclusion & exclusion criteria

Inclusion criteria:
-Men 45 years of age or older at Screening Visit.
-Provide signed informed consent at Screening Visit.
-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.
-Have not taken the following treatments within the indicated duration:
[a] Finasteride therapy for at least 3 months prior to Placebo Lead in Visit.
[b] Dutasteride therapy for at least 6 months prior to Placebo Lead in Visit.
[c] Other BPH therapy (including herbal preparations) for at least
4 weeks prior to Placebo Lead in Visit.
[d] OAB therapy for at least 4 weeks prior to Placebo Lead in Visit.
[e] ED therapy for at least 4 weeks prior to Placebo Lead in Visit.
[f] Other experimental or off-label BPH therapy, such as injectable therapies with a protracted effect, for at least 1/2 year prior to Placebo Lead in Visit.
-Have LUTS with a Total IPSS >=13 at Placebo Lead in Visit.
-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) at Placebo Lead in Visit.
-Demonstrate compliance with study drug administration requirements during the placebo lead-in period by administering >=70% of prescribed doses, confirmed by documentation that the subject returned <=30% of prescribed doses at Randomization Visit.
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

Exclusion criteria:
-PSA >10.0 ng/mL at Screening Visit.
-PSA >=4.0 to <=10.0 ng/mL at Screening Visit if prostate malignancy has not been ruled out to the satisfaction of an urologist.
-Bladder PVR >=300 mL by ultrasound determination at Screening Visit.
-History of any of the following pelvic conditions:
[a] Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or bowel resection.
[b] Pelvic radiotherapy.
[c] Any pelvic surgical procedure of the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery.
[d] Lower urinary tract malignancy or trauma.
-Lower urinary tract instrumentation within 30 days of Screening Visit.
-History of urinary retention or lower urinary tract stones within 6 months of Screening Visit.
-History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
-Clinical evidence of any of the following bladder conditions:
[a] Mullerian duct cysts.
[b] Atonic, decompensated, or hypocontractile bladder.
[c] Detrusor-sphincter dyssynergia.
[d] Intravesical obstruction.
[e] Interstitial cystitis.
-Clinical evidence of any of the following urinary tract conditions at Screening Visit :
[a] Urinary tract infection.
[b] Urinary tract inflammation.
[c] Current antibiotic therapy for urinary tract infection.
[d] Clinically significant microscopic hematuria as determined by a urologist.
-Clinical evidence of prostate cancer.
-Current neurologic disease or condition associated with neurogenic bladder.
-History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance <30 mL/minute at Screening Visit as calculated by the central laboratory using the Cockroft-Gault Formula.
-Clinical evidence of severe hepatic impairment at Screening Visit.
-History of any of the following cardiac conditions:
[a] Angina requiring treatment with long-acting nitrates.
[b] Angina requiring treatment with short-acting nitrates within 90 days of Screening Visit.
[c] Unstable angina within 90 days of Screening Visit.
[d] Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention.
-History of any of the following coronary conditions within 90 days of Screening Visit :
[a] Myocardial infarction.
[b] Coronary artery bypass graft surgery.
[c] Percutaneous coronary intervention.
-Any evidence of heart disease (New York Heart Association [NYHA] >=Class III within 6 months of Screening Visit.
-Systolic blood pressure >160 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at Screening Visit, or malignant hypertension.
-Scheduled or planned surgery during the course of the study.
-Scheduled or planned cataract surgery during the course of the study due to risk of intraoperative floppy iris syndrome (IFIS).
-History of significant central nervous system injuries within 6 months of Screening Visit.
-History of drug, alcohol, or substance abuse within 6 months of Screening Visit.
-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.
-Current treatment with nitrates, androgens, antiandrogens, estrogens, luteinizing
hormone-releasing hormone agonists/antagonists, or anabolic steroids.
-Current systemic treatment with any of the following:
[a] Potent cytochrome P450 3A4 (CYP3A4) inhibitors, such as ketocon

Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Benign Prostatic Hyperplasia (BPH)
MedDRA version: 9.1 Level: LLT Classification code 10004446 Term: Benign prostatic hyperplasia

Intervention(s)

Trade Name: Cialis
Product Name: tadalafil
Product Code: LY450190
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tadalafil
CAS Number: 171596-29-5
Current Sponsor code: 450190
Other descriptive name: TADALAFIL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5mg-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Omnic MR
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: TAMSULOSIN HYDROCHLORIDE
CAS Number: 106463176
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.4-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Change in IPSS from baseline after 12 weeks.

Main Objective: Change from baseline in International Prostate Symptom Score (IPSS) at 12 weeks, tadalafil compared with placebo.

Secondary Objective: To evaluate the:
- Change from baseline in International Prostate Symptom Score (IPSS) at 12 weeks, tamsulosin compared with placebo.
- Change from baseline in modified International Prostate Symptom Score (mIPSS) at 1 week) and in IPSS at 4 weeks.
- Change from baseline at 12 weeks in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF).
- Uroflowmetry measurements.
-safety of tadalafil in treating BPH.

Secondary ID(s)

2009-010739-42-DE

H6D-MC-LVID

Ethics review

Status: Approved
Approval date: 21/07/2009
Contact:

Results

• Results available: Yes
• Date Posted: 05/01/2017
• Date Completed: 27/01/2011
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-010739-42/results