A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia. (COMORBID©)


Tracking Information

Start Date  ICMJEMarch 2009
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
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 ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00855582 on ClinicalTrials.gov Archive Site
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 ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia.
Official Title  ICMJEA 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
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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Erectile Dysfunction
  • Benign Prostatic Hyperplasia
Intervention  ICMJE
  • Drug: Tadalafil
    tablet once daily by mouth for 12 weeks.
    Other Names:
    • Cialis
    • LY450190
  • Drug: Placebo
    Matching 2.5 or 5 mg placebo tablet once daily by mouth for 12 weeks.
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

Recruitment Information

Estimated Enrollment  ICMJE501
Estimated Completion DateJune 2010
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
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.
GenderMale
Ages45 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
Location Countries  ICMJEUnited States,   Canada,   France,   Germany,   Greece,   Italy,   Mexico,   Portugal,   Russian Federation

Administrative Information

NCT ID  ICMJENCT00855582
Responsible PartyChief Medical Officer, Eli Lilly
Study ID Numbers  ICMJE11667, H6D-MC-LVHR
Study Sponsor  ICMJEEli Lilly and Company
Collaborators  ICMJE 
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
Information Provided ByEli Lilly and Company