Benign prostatic hyperplasia and erectile dysfunction. MedDRA version: 9.1 Level: LLT Classification code 10061461 MedDRA version: 9.1 Level: LLT Classification code 10004446
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tadalafil
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placeb
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -men 45 years of age or older at Visit 1. -Present with BPH LUTS based on the disease diagnostic criteria (Section 8.1.1) at Visit 1 and have a history of ED based on the disease diagnostic criteria (Section 8.1.2) at Visit 1. -Have LUTS with a Total IPSS 13 at Visit 2. -Have bladder outlet obstruction as defined by a 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 Visit 2 (see Protocol Attachment LVHR.3). -Make at least 4 sexual intercourse attempts during the 4-week placebo lead-in period, as recorded in the SEP diary. -Are sexually active with an adult female partner, and expect to remain sexually active with the same adult female partner for the duration of the study. -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 Visit 3. -Agree not to use any other approved or experimental pharmacologic BPH, OAB, or ED treatments, including alpha blockers, 5 ARIs, antimuscarinics, 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 Visit 2. [b] Dutasteride therapy for at least 6 months prior to Visit 2. [c] All other BPH therapy (including herbal preparations) for at least 4 weeks prior to Visit 2. [d] OAB therapy for at least 4 weeks prior to Visit 2. [e] ED therapy (including herbal preparations) for at least 4 weeks prior to Visit 2. -Provide signed informed consent at Visit 1. 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
Exclusion criteria: -PSA 10.0ng/mL at V1-PSA4.0 to 10.0ng/mL at V1 if prostate malignancy has not been ruled out to the satisfaction of a urologist-Bladder PVR 300 mL at V1-Pelvic surgery or other pelvic procedure, including radical prostatectomy,pelvic surgery for removal of malignancy or bowel resection,pelvic radiotherapy,any pelvic surgical procedure of the urinary tract, including minimally invasive BPH LUTS therapies and penile implant surgery,lower urinary tract malignancy or trauma-Lower urinary tract instrumentation within 30days of V1-Urinary retention or lower urinary tract stones within 6months of V1-Severe hepatic impairment at V1-Urethral obstruction due to stricture, valves, sclerosis, or tumor-Bladder conditions:mullerian duct cysts,atonic,decompensated or hypocontractile bladder,detrusor-sphincter dyssynergia,intravesical obstruction.Interstitial cystitis-Urinary tract conditions at V1:urinary tract infection,urinary tract inflammation,current antibiotic therapy for urinary tract infection,significant microscopic hematuria as determined by a urologist-Prostate cancer-Current neurologic disease or condition associated with neurogenic bladder-Significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance 30 mL/minute at V1-ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated endocrine disease-Presence of clinically significant penile deformity-Cardiac conditions:chronic stable angina treated with long-acting nitrates,angina requiring treatment with short-acting nitrates within 90 days of V1,unstable angina within 90 days of V1,angina occurring during sexual intercourse in the last 6months,positive cardiac stress test-Coronary conditions within 90 days of V1:myocardial infarction,coronary artery bypass graft surgery,percutaneous coronary intervention-New significant cardiac conduction defect within 90 days prior V1-Supraventricular arhythmia with mean heart rate >100 bpm at rest despite medical or device therapy or heart rate >100 bpm for 30 sec despite medical or device therapy or presence of an automatic internal cardioverter-defibrillator-Resuscitated cardiac arrest-Heart disease (NYHA  Class II) within 6 months of V1-Systolic blood pressure 160 or 90 mmHg or diastolic blood pressure 100 or 50 mmHg at V1 or malignant hypertension-HIV infection-Scheduled or planned surgery (or procedure requiring general,spinal or epidural anesthesia)during the study-History of significant central nervous system injuries within 6 months of V1-Drug,alcohol or substance abuse within 6 months of V1-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-Treatment with nitrates, androgens, antiandrogens, estrogens,luteinizing hormone releasing hormone agonists/antagonists,anabolic steroids or cancer chemotherapy-Systemic treatment with potent cytochrome P450 3A4 (CYP3A4) inhibitors,CYP3A4 inducers-HbA1c 9% at V1-Known or suspected hypersensitivity to tadalafil or drug components-Prior treatment with PDE5 inhibitors judged to be ineffective-Investigator site personnel affiliated with this study and/or their immediate families-Lilly employees and their immediate family-Cur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The evaluate the efficacy of tadalafil once daily for 12 weeks compared with placebo in improving both IPSS and IIEF Erectile Function (EF) Domain in men with both ED and signs and symptoms of BPH.;Secondary Objective: •efficacy of tadalafil 2.5&5mg daily for 12 weeks v placebo in improving Patient Sexual Encounter Profile (SEP) diary Question 3. •efficacy of tadalafil 2.5&5mg daily for 12 weeks v placebo in improving BII. •safety of tadalafil 2.5&5mg daily for 12 weeks. •change in mIPSS from baseline to 2 weeks for tadalafil 2.5&5mg daily versus placebo. •change in IPSS, IIEF EF Domain, SEP diary Question 3, and BII from baseline to 4 and 8 weeks for tadalafil 2.5&5mg daily v placebo. •change in IPSS subscores,IIEF Overall and Intercourse Satisfaction Domains,IIEF Questions 3 and 4,and SEP diary Questions 2, 4, and 5 from baseline to 4, 8, and 12 weeks for tadalafil 2.5&5mg daily v placebo. •impact of tadalafil 2.5&5mg daily for 12 weeks v placebo on urinary symptoms of BPH LUTS. •impact of tadalafil 2.5&5mg daily for 12 weeks v placebo on improving erectile function. •change in uroflowmetry parameters from baseline to 12 weeks for tadalafil 2.5 and 5 mg once daily versus placebo;Primary end point(s): Mean changes from baseline to the end of therapy in Total IPSS and IIEF EF Domain Score. | — |
Countries
France, Germany, Greece, Italy, Portugal
Outcome results
None listed