A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia
NCT ID: NCT00855582
Last Updated: 2011-07-28
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
606 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-03-31
Study Completion Date
2010-07-31
Brief Summary
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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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Conditions
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Erectile Dysfunction
Benign Prostatic Hyperplasia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Study Groups
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Tadalafil 2.5 mg
Group Type
EXPERIMENTAL
Tadalafil
Intervention Type
DRUG
tablet once daily by mouth for 12 weeks.
Tadalafil 5 mg
Group Type
EXPERIMENTAL
Tadalafil
Intervention Type
DRUG
tablet once daily by mouth for 12 weeks.
Placebo
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Matching 2.5 or 5 mg placebo tablet once daily by mouth for 12 weeks.
Interventions
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Tadalafil
tablet once daily by mouth for 12 weeks.
Intervention Type
DRUG
Placebo
Matching 2.5 or 5 mg placebo tablet once daily by mouth for 12 weeks.
Intervention Type
DRUG
Other Intervention Names
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Cialis
LY450190
Eligibility Criteria
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Inclusion Criteria
* Have BPH Lower Urinary Tract Symptoms (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 LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 at 2nd screening.
* Have bladder outlet obstruction as defined by a Peak Urine Flow Rate (Qmax) of greater than or equal to 4 to less than or equal to 15 milliliter (mL)/second (sec) (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 Sexual Encounter Profile (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, overactive bladder (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.
* Have a history of ED based on the disease diagnostic criteria at 1st screening.
* Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 at 2nd screening.
* Have bladder outlet obstruction as defined by a Peak Urine Flow Rate (Qmax) of greater than or equal to 4 to less than or equal to 15 milliliter (mL)/second (sec) (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 Sexual Encounter Profile (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, overactive bladder (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.
* Prostate-specific antigen (PSA) greater than 10.0 nanogram (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 postvoid residual volume (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.
* Glycosylated hemoglobin (HbA1c) greater than 9% at 1st screening.
* Prior treatment with phosphodiesterase type 5 (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.
* Prostate-specific antigen (PSA) greater than 10.0 nanogram (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 postvoid residual volume (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.
* Glycosylated hemoglobin (HbA1c) greater than 9% at 1st screening.
* Prior treatment with phosphodiesterase type 5 (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.
Minimum Eligible Age
45 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Eli Lilly
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Anchorage, Alaska, United States
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Phoenix, Arizona, United States
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Tarzana, California, United States
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Englewood, Colorado, United States
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Urbana, Illinois, United States
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West Des Moines, Iowa, United States
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Missoula, Montana, United States
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Surrey, British Columbia, Canada
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Victoria, British Columbia, Canada
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Saint John, New Brunswick, Canada
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Barrie, Ontario, Canada
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Kitchener, Ontario, Canada
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Carpentras, , France
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Lyon, , France
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Nice, , France
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Nîmes, , France
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Orléans, , France
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Toulouse, , France
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Bad Rappenau, , Germany
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Frankfurt, , Germany
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Holzminden, , Germany
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Kempen, , Germany
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Athens, , Greece
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Heraklion, , Greece
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Larissa, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Genova, , Italy
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Milan, , Italy
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Sassari, , Italy
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Trieste, , Italy
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Colima, , Mexico
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Durango, , Mexico
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La Joya, , Mexico
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Mexico City, , Mexico
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Morelia, , Mexico
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Amadora, , Portugal
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Coimbra, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Moscow, , Russia
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Rostov-on-Don, , Russia
Site Status
Countries
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United States
Canada
France
Germany
Greece
Italy
Mexico
Portugal
Russia
References
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Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Buttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24.
Reference Type
DERIVED
Porst H, Gacci M, Buttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.
Reference Type
DERIVED
Other Identifiers
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H6D-MC-LVHR
Identifier Type: OTHER
Identifier Source: secondary_id
11667
Identifier Type: -
Identifier Source: org_study_id
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NCT00654914
COMPLETED
PHASE3
To Assess the Safety of Avanafil in Healthy and Hepatically Impaired Male Subjects.
NCT01054430
COMPLETED
PHASE1
Depression Related Improvement With Vardenafil for Erectile Response
NCT00661219
COMPLETED
PHASE3
A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.
NCT00668096
COMPLETED
PHASE4