A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia

Last updated: July 26, 2011
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Erectile Dysfunction

Prostate Disorders

Infertility

Treatment

N/A

Clinical Study ID

NCT00855582
11667
H6D-MC-LVHR
  • Ages > 45
  • Male

Study 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.

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

Total Participants: 606
Study Start date:
March 01, 2009
Estimated Completion Date:
July 31, 2010

Connect with a study center

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    Surrey, British Columbia V3V 1N1
    Canada

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    Victoria, British Columbia V8V 3N1
    Canada

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    St. John, New Brunswick E2L 3J8
    Canada

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    Barrie, Ontario L4M 7G1
    Canada

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    Kitchener, Ontario N2N 3B9
    Canada

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    Carpentras, 84200
    France

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    Lyon, 69437
    France

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    Nice, 06002
    France

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    Nimes, 30029
    France

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    Orleans, 45067
    France

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    Toulouse, 31059
    France

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    Bad Rappenau, 74906
    Germany

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    Frankfurt, D-65933
    Germany

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    Holzminden, D-37603
    Germany

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    Kempen, 47906
    Germany

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    Athens, 11527
    Greece

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    Heraklion, 71110
    Greece

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    Larissa, 41221
    Greece

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    Patras, 26500
    Greece

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    Thessaloniki, 56429
    Greece

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    Genova, 16132
    Italy

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    Milan, 20132
    Italy

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    Sassari, 07100
    Italy

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    Trieste, 31149
    Italy

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    Colima, 28000
    Mexico

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    Durango, 34000
    Mexico

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    La Joya, 14000
    Mexico

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    Mexico City, 14050
    Mexico

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    Morelia, 58000
    Mexico

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    Amadora, 2700-351
    Portugal

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    Coimbra, 3000-075
    Portugal

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    Lisbon, 1250-203
    Portugal

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    Porto, 4202-451
    Portugal

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    Moscow, 119435
    Russian Federation

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    Rostov-On-Don, 344011
    Russian Federation

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    Anchorage, Alaska 99508
    United States

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    Phoenix, Arizona 85050
    United States

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    La Mesa, California 91942
    United States

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    Los Angeles, California 90017
    United States

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    Newport Beach, California 92660
    United States

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    San Diego, California 92120
    United States

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    Tarzana, California 91356
    United States

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    Englewood, Colorado 80113
    United States

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    Urbana, Illinois 61801
    United States

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    West Des Moines, Iowa 50266
    United States

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    Minneapolis, Minnesota 55455
    United States

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    Missoula, Montana 59802
    United States

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    Edmond, Oklahoma 73034
    United States

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    Dallas, Texas 75231
    United States

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    San Antonio, Texas 78229
    United States

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    Mountlake Terrace, Washington 98043
    United States

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    Spokane, Washington 99202
    United States

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