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A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia. (COMORBID©)
This study is currently recruiting participants.
Verified by Eli Lilly and Company, October 2009
First Received: March 3, 2009   Last Updated: October 5, 2009   History of Changes
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00855582
  Purpose

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.


Condition Intervention Phase
Erectile Dysfunction
Benign Prostatic Hyperplasia
Drug: Tadalafil
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 501
Study Start Date: March 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tadalafil 2.5 mg: Experimental Drug: Tadalafil
tablet once daily by mouth for 12 weeks.
Tadalafil 5 mg: Experimental Drug: Tadalafil
tablet once daily by mouth for 12 weeks.
Placebo: Placebo Comparator Drug: Placebo
Matching 2.5 or 5 mg placebo tablet once daily by mouth for 12 weeks.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855582

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Hide Study Locations
Locations
United States, Alaska
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Anchorage, Alaska, United States, 99508
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United States, Arizona
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Phoenix, Arizona, United States, 85050
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United States, California
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La Mesa, California, United States, 91942
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San Diego, California, United States, 92120
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Newport Beach, California, United States, 92660
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Los Angeles, California, United States, 90017
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Tarzana, California, United States, 91356
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United States, Colorado
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Englewood, Colorado, United States, 80113
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United States, Illinois
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Urbana, Illinois, United States, 61801
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United States, Iowa
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West Des Moines, Iowa, United States, 50266
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United States, Minnesota
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Minneapolis, Minnesota, United States, 55455
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United States, Montana
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Missoula, Montana, United States, 59802
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United States, Oklahoma
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Edmond, Oklahoma, United States, 73034
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United States, Texas
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Dallas, Texas, United States, 75231
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San Antonio, Texas, United States, 78229
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United States, Washington
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Mountlake Terrace, Washington, United States, 98043
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Spokane, Washington, United States, 99202
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Canada, British Columbia
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Surrey, British Columbia, Canada, V3V 1N1
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Victoria, British Columbia, Canada, V8V 3N1
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Canada, New Brunswick
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St. John, New Brunswick, Canada, E2L 3J8
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Canada, Ontario
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Barrie, Ontario, Canada, L4M 7G1
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Kitchener, Ontario, Canada, N2N 3B9
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France
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Carpentras, France, 84200
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Lyon, France, 69437
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Nice, France, 06002
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Nimes, France, 30029
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Orleans, France, 45067
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Toulouse, France, 31059
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Germany
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Bad Rappenau, Germany, 74906
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Frankfurt, Germany, D-65933
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Kempen, Germany, 47906
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Holzminden, Germany, D-37603
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Goettingen, Germany, 37073
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Greece
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Athens, Greece, 11527
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Heraklion, Greece, 71110
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Larissa, Greece, 41221
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Patras, Greece, 26500
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Thessaloniki, Greece, 56429
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Italy
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Genova, Italy, 16132
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Milan, Italy, 20132
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Sassari, Italy, 07100
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Trieste, Italy, 31149
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Mexico
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Colima, Mexico, 28000
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Durango, Mexico, 34000
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Morelia, Mexico, 58000
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Mexico City, Mexico, 14050
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La Joya, Mexico, 14000
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Portugal
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Amadora, Portugal, 2700-351
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Coimbra, Portugal, 3000-075
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Lisbon, Portugal, 1549-008
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Porto, Portugal, 4202-451
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Russian Federation
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Moscow, Russian Federation, 119435
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Rostov-On-Don, Russian Federation, 344011
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 11667, H6D-MC-LVHR
Study First Received: March 3, 2009
Last Updated: October 5, 2009
ClinicalTrials.gov Identifier: NCT00855582     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Erectile Dysfunction
Benign Prostatic Hyperplasia

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunctions, Psychological
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases
Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Pharmacologic Actions
Hyperplasia
Pathologic Processes
Sexual Dysfunction, Physiological
Phosphodiesterase Inhibitors
Prostatic Hyperplasia
Mental Disorders
Tadalafil

ClinicalTrials.gov processed this record on November 20, 2009