Status:
COMPLETED
A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia
Lead Sponsor:
Eli Lilly and Company
Conditions:
Erectile Dysfunction
Benign Prostatic Hyperplasia
Eligibility:
MALE
45+ years
Phase:
PHASE3
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 be...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
606 Patients enrolled
Trial Details
Trial ID
NCT00855582
Start Date
March 1 2009
End Date
July 1 2010
Last Update
July 28 2011
Active Locations (52)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Anchorage, Alaska, United States, 99508
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Phoenix, Arizona, United States, 85050
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
La Mesa, California, United States, 91942
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles, California, United States, 90017