Phase
Condition
Erectile Dysfunction
Prostate Disorders
Infertility
Treatment
N/AClinical Study ID
Ages > 45 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have BPH Lower Urinary Tract Symptoms (LUTS) based on the disease diagnostic criteriaat 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 orequal to 13 at 2nd screening.
Have bladder outlet obstruction as defined by a Peak Urine Flow Rate (Qmax) of greaterthan or equal to 4 to less than or equal to 15 milliliter (mL)/second (sec) (from aprevoid total bladder volume as assessed by ultrasound of greater than or equal to 150to less than or equal to 550 mL and a minimum voided volume of 125 mL) at 2ndscreening.
Make at least 4 sexual intercourse attempts during the 4-weeks after 2nd screening asrecorded in the Sexual Encounter Profile (SEP) diary.
Are sexually active with an adult female partner, and expect to remain sexually activewith the same adult female partner for the duration of the study.
Agree not to use any other approved or experimental BPH, overactive bladder (OAB), orED 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
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 screeningif 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 ultrasounddetermination at 1st screening.
History or clinical evidence of certain pelvic, bladder, urinary tract, or urinaryretention conditions described in the protocol.
Lower urinary tract instrumentation (including prostate biopsy) within 30 days of 1stscreening.
Clinical evidence of severe hepatic impairment at 1st screening.
Current neurologic disease or condition associated with neurogenic bladder (forexample, 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 ejaculationor 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 epiduralanesthesia) during the course of the study.
History of significant central nervous system injuries (including stroke or spinalcord 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 theinvestigator to be ineffective. However, if the investigator judges that a subject'slack of response to as-needed PDE5 inhibitors is the result of inadequate coordinationbetween dosing and sexual activity with a treatment, the subject may be enrolled.
Study Design
Connect with a study center
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Surrey, British Columbia V3V 1N1
CanadaSite Not Available
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Victoria, British Columbia V8V 3N1
CanadaSite Not Available
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St. John, New Brunswick E2L 3J8
CanadaSite Not Available
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Barrie, Ontario L4M 7G1
CanadaSite Not Available
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Kitchener, Ontario N2N 3B9
CanadaSite Not Available
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Carpentras, 84200
FranceSite Not Available
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Lyon, 69437
FranceSite Not Available
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Nice, 06002
FranceSite Not Available
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Nimes, 30029
FranceSite Not Available
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Orleans, 45067
FranceSite Not Available
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Toulouse, 31059
FranceSite Not Available
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Bad Rappenau, 74906
GermanySite Not Available
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Frankfurt, D-65933
GermanySite Not Available
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Holzminden, D-37603
GermanySite Not Available
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Kempen, 47906
GermanySite Not Available
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Athens, 11527
GreeceSite Not Available
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Heraklion, 71110
GreeceSite Not Available
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Larissa, 41221
GreeceSite Not Available
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Patras, 26500
GreeceSite Not Available
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Thessaloniki, 56429
GreeceSite Not Available
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Genova, 16132
ItalySite Not Available
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Milan, 20132
ItalySite Not Available
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Sassari, 07100
ItalySite Not Available
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Trieste, 31149
ItalySite Not Available
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Colima, 28000
MexicoSite Not Available
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Durango, 34000
MexicoSite Not Available
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La Joya, 14000
MexicoSite Not Available
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Mexico City, 14050
MexicoSite Not Available
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Morelia, 58000
MexicoSite Not Available
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Amadora, 2700-351
PortugalSite Not Available
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Coimbra, 3000-075
PortugalSite Not Available
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Lisbon, 1250-203
PortugalSite Not Available
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Porto, 4202-451
PortugalSite Not Available
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Moscow, 119435
Russian FederationSite Not Available
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Rostov-On-Don, 344011
Russian FederationSite Not Available
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Anchorage, Alaska 99508
United StatesSite Not Available
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Phoenix, Arizona 85050
United StatesSite Not Available
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La Mesa, California 91942
United StatesSite Not Available
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Los Angeles, California 90017
United StatesSite Not Available
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Newport Beach, California 92660
United StatesSite Not Available
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San Diego, California 92120
United StatesSite Not Available
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Tarzana, California 91356
United StatesSite Not Available
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Englewood, Colorado 80113
United StatesSite Not Available
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Urbana, Illinois 61801
United StatesSite Not Available
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West Des Moines, Iowa 50266
United StatesSite Not Available
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Minneapolis, Minnesota 55455
United StatesSite Not Available
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Missoula, Montana 59802
United StatesSite Not Available
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Edmond, Oklahoma 73034
United StatesSite Not Available
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Dallas, Texas 75231
United StatesSite Not Available
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San Antonio, Texas 78229
United StatesSite Not Available
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Mountlake Terrace, Washington 98043
United StatesSite Not Available
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Spokane, Washington 99202
United StatesSite Not Available
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