A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia. (COMORBID©)
Tracking InformationStart Date ICMJE | March 2009 |
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Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE (submitted: March 3, 2009) | - Change from baseline in International Prostate Symptom Score (IPSS) total score (5mg). [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain score (5mg). [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in International Prostate Symptom Score (IPSS) total score (2.5mg). [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain score (2.5mg). [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT00855582 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: March 3, 2009) | - Change from baseline in Yes responses to Sexual Encounter Profile (SEP) diary Question 3 (5mg). [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in BPH Impact Index (BII) (5mg). [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
- Change from baseline in Yes responses to Sexual Encounter Profile (SEP) diary Question 3 (2.5mg). [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in BPH Impact Index (BII) (2.5mg). [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
- Change in Modified IPSS (mIPSS). [ Time Frame: baseline, 2 weeks ] [ Designated as safety issue: No ]
- Change in International Prostate Symptom Score (IPSS). [ Time Frame: baseline, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
- Change in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain. [ Time Frame: baseline, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
- Change in Yes responses to Sexual Encounter Profile (SEP) diary Question 3. [ Time Frame: baseline, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
- Change in BPH Impact Index (BII) [ Time Frame: baseline, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
- Change in International Prostate Symptom Score subscores. [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
- Change in International Prostate Symptom Score Quality of Life (QoL) Question 8. [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
- Change in International Index of Erectile Function - Overall Satisfaction Domain. [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
- Change in International Index of Erectile Function - Intercourse Satisfaction Domain. [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
- Change in International Index of Erectile Function Question 3. [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
- Change in International Index of Erectile Function Question 4. [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
- Change in urinary symptoms of BPH-LUTS as assessed by the Patient Global Impression of Improvement (PGI-I). [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
- Change in urinary symptoms of BPH-LUTS as assessed by the Clinician Global Impression of Improvement (CGI-I). [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
- Erectile Function General Assessment Questionnaire (EF-GAQ). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in Uroflowmetry parameters - Qmax, Qmean. [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
- Change in Uroflowmetry parameters - Vcomp. [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
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Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive InformationBrief Title ICMJE | A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia. |
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Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5 mg Once Daily Dosing for 12 Weeks for the Treatment of Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia in Men With Both Erectile Dysfunction and Benign Prostatic Hyperplasia |
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Brief Summary | Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH. |
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Detailed Description | |
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Study Phase | Phase III |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | - Erectile Dysfunction
- Benign Prostatic Hyperplasia
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Intervention ICMJE | |
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Study Arms / Comparison Groups | - Tadalafil 2.5 mg: Experimental
Intervention: Drug: Tadalafil - Tadalafil 5 mg: Experimental
Intervention: Drug: Tadalafil - Placebo: Placebo Comparator
Intervention: Drug: Placebo
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Recruitment InformationEstimated Enrollment ICMJE | 501 |
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Estimated Completion Date | June 2010 |
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Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
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Eligibility Criteria ICMJE | Inclusion Criteria: - Have BPH LUTS based on the disease diagnostic criteria at 1st screening.
- Have a history of ED based on the disease diagnostic criteria at 1st screening.
- Have Lower Urinary Tract Symptoms (LUTS) with a Total IPSS greater than or equal to 13 at 2nd screening.
- Have bladder outlet obstruction as defined by a Qmax of greater than or equal to 4 to less than or equal to 15 mL/second (from a prevoid total bladder volume as assessed by ultrasound of greater than or equal to 150 to less than or equal to 550 mL and a minimum voided volume of 125 mL) at 2nd screening.
- Make at least 4 sexual intercourse attempts during the 4-weeks after 2nd screening 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.
- Agree not to use any other approved or experimental BPH, OAB, or ED treatments as indicated in the protocol at any time during the study.
- Have not taken treatments indicated in the protocol prior to the 2nd screening.
Exclusion Criteria: - Current treatment with nitrates.
- PSA greater than 10.0 ng/mL at 1st screening.
- PSA greater than or equal to 4.0 to less than or equal to 10.0 ng/mL at 1st screening if prostate malignancy has not been ruled out to the satisfaction of a urologist.
- Clinical evidence of prostate cancer.
- Bladder PVR greater than or equal to 300 mL by ultrasound determination at 1st screening.
- History or clinical evidence of certain pelvic, bladder, urinary tract, or urinary retention conditions described in the protocol.
- Lower urinary tract instrumentation (including prostate biopsy) within 30 days of 1st screening.
- Clinical evidence of severe hepatic impairment at 1st screening.
- Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease or multiple sclerosis).
- History of significant renal insufficiency as defined by the protocol.
- History of ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated endocrine disease.
- Presence of penile deformity judged by the investigator to be clinically significant.
- History of certain cardiac or cardiovascular conditions described in the protocol.
- History of resuscitated cardiac arrest.
- Current treatment with certain medications described in the protocol.
- Scheduled or planned surgery (or any procedure requiring general, spinal, or epidural anesthesia) during the course of the study.
- History of significant central nervous system injuries (including stroke or spinal cord injury) within 6 months of 1st screening.
- HbA1c greater than 9% at 1st screening.
- Prior treatment with PDE5 inhibitors judged by the investigator to be ineffective. However, if the investigator judges that a subject's lack of response to as-needed PDE5 inhibitors is the result of inadequate coordination between dosing and sexual activity with a treatment, the subject may be enrolled.
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Gender | Male |
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Ages | 45 Years and older |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | | |
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Location Countries ICMJE | United States, Canada, France, Germany, Greece, Italy, Mexico, Portugal, Russian Federation |
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Administrative InformationNCT ID ICMJE | NCT00855582 |
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Responsible Party | Chief Medical Officer, Eli Lilly |
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Study ID Numbers ICMJE | 11667, H6D-MC-LVHR |
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Study Sponsor ICMJE | Eli Lilly and Company |
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Collaborators ICMJE | |
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Investigators ICMJE | Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | |
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Information Provided By | Eli Lilly and Company |
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