Erectile DysfunctionPhase 3COMORBID©NCT00855582

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

A Phase 3 study testing Tadalafil in people with Erectile Dysfunction and Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 52 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 45 years and older, men only
Conditions the study is for: Erectile Dysfunction, Benign Prostatic Hyperplasia
What is being tested?: Tadalafil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 606 participants
Where: 52 sitesin 9 countries
Study dates: Mar 2009to Jul 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

52 sites in 9 countries.

Country

City, postcode or hospital

52 sites in 9 countries

United States17 sites

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, 99508
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Dallas, Texas, 75231
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Edmond, Oklahoma, 73034
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Englewood, Colorado, 80113
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La Mesa, California, 91942
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Los Angeles, California, 90017
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Minneapolis, Minnesota, 55455
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Missoula, Montana, 59802
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Mountlake Terrace, Washington, 98043
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Newport Beach, California, 92660
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Phoenix, Arizona, 85050
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San Antonio, Texas, 78229
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San Diego, California, 92120
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Spokane, Washington, 99202
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Tarzana, California, 91356
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Urbana, Illinois, 61801
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West Des Moines, Iowa, 50266

Other trials in United States

France6 sites

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Carpentras, 84200
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Lyon, 69437
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Nice, 06002
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Nîmes, 30029
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Orléans, 45067
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Toulouse, 31059

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Canada5 sites

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Barrie, Ontario, L4M 7G1
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Kitchener, Ontario, N2N 3B9
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Saint John, New Brunswick, E2L 3J8
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Surrey, British Columbia, V3V 1N1
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Victoria, British Columbia, V8V 3N1

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Greece5 sites

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Athens, 11527
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Heraklion, 71110
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Larissa, 41221
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Pátrai, 26500
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Thessaloniki, 56429

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Mexico5 sites

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Colima, 28000
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Durango, 34000
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La Joya, 14000
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Mexico City, 14050
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Morelia, 58000

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Germany4 sites

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Bad Rappenau, 74906
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Frankfurt, D-65933
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Holzminden, D-37603
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Kempen, 47906

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Italy4 sites

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Genova, 16132
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Milan, 20132
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Sassari, 07100
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Trieste, 31149

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Portugal4 sites

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Amadora, 2700-351
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Coimbra, 3000-075
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Lisbon, 1250-203
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Porto, 4202-451

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Russia2 sites

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Moscow, 119435
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Rostov-on-Don, 344011

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About this 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

Conditions: Erectile Dysfunction, Benign Prostatic Hyperplasia
Being tested: Tadalafil, Placebo
Keywords: Erectile Dysfunction, Benign Prostatic Hyperplasia
Medical subject headings: Erectile Dysfunction, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TadalafilDrug
Also called Cialis, LY450190
tablet once daily by mouth for 12 weeks.
PlaceboDrug
Matching 2.5 or 5 mg placebo tablet once daily by mouth for 12 weeks.

Study groups in NCT00855582
Study group	Role	What they receive
Tadalafil 2.5 mg	Experimental	Not described Receives: Drug: Tadalafil
Tadalafil 5 mg	Experimental	Not described Receives: Drug: Tadalafil
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg)
The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg)
Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg)
The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg)
Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks

Secondary outcomes (26)

Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg)
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of Yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg)
The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg)
The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint
The Modified IPSS is the total IPSS collected at 2 weeks post-baseline. The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 2 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint
The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 4 weeks, 8 weeks
Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain at Week 4 and Week 8 Endpoint
Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 4 weeks, 8 weeks
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 4 and Week 8 Endpoint
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 4 weeks, 8 weeks
Change From Baseline in BPH Impact Index (BII) at Week 4 and 8 Endpoint
The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 4 weeks, 8 weeks
Change From Baseline in International Prostate Symptom Score Voiding (Obstructive) Subscore at Week 12 Endpoint
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. The obstructive subscore ranges from 0 to 20 with a higher score representing greater obstruction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score Storage (Irritative) Subscore at Week 12 Endpoint
IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. The irritative subscore ranges from 0 to 15 with a higher score representing more irritative symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score Nocturia Question at Week 12
The IPSS Nocturia question (Question 7) measures the number of times needed to get up at night to urinate. Scores range from 0 (none) to 5 (5 or more times). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score Quality of Life (QoL) at Week 12 Endpoint
Assessment of quality of life (QoL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in International Index of Erectile Function - Overall Satisfaction Domain at Week 12 Endpoint
Self-reported overall satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 13 and 14. Each question is scored from 1 through 5, with a possible total score of 2 through 10. Higher scores represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in International Index of Erectile Function - Intercourse Satisfaction Domain at Week 12 Endpoint
Self-reported intercourse satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 6, 7 and 8. Each question is scored from 0 through 5 with a possible total score of 0 through 15. Higher score represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in International Index of Erectile Function Question 3 at Week 12 Endpoint
IIEF Question 3 asks how often a subject was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in International Index of Erectile Function Question 4 at Week 12 Endpoint
IIEF Question 4 asks whether how often a subject was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 2 at Week 12 Endpoint
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2, "Were you able to insert your penis into your partner's vagina?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 4 at Week 12 Endpoint
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4, "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 5
Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5, "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Measured: Baseline, 12 weeks
Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint
A scale that measures the patient's perception of urinary symptoms at endpoint compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).
Measured: 12 weeks
Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint
A scale that measures clinician's rating of the total change in the patient's urinary symptoms at endpoint compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).
Measured: 12 weeks
Erectile Function General Assessment Questionnaire (EF-GAQ)
The EF-GAQ consisted of two questions: (1) Has the treatment you have been taking during this study improved your erections? and (2) If yes, has the treatment improved your ability to engage in sexual activity? Each question has a Yes/No response.
Measured: 12 weeks
Change From Baseline in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) at Week 12 Endpoint
Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.
Measured: Baseline, 12 weeks
Change From Baseline in Uroflowmetry Parameters - Mean Urine Flow Rate (Qmean) at Week 12 Endpoint
Qmean is defined as the average urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.
Measured: Baseline, 12 weeks
Change From Baseline in Uroflowmetry Parameters - Voided Volume (Vcomp) at Week 12 Endpoint
Vcomp is defined as the volume of urine voided (measures in mL using a standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.
Measured: Baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Jul 2010

First posted4 Mar 2009 (estimated)
Study startMar 2009
Primary completionJul 2010
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 606 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00855582
Sponsor's protocol ID: 11667
Other IDs: H6D-MC-LVHR
Acronym: COMORBID©
Status last verified: Jul 2011
First submitted: 3 Mar 2009
Last updated: 28 Jul 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 26299520
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.
PubMed 24119319

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Erectile Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00855582
Acronym / sponsor ID: COMORBID© / 11667
Conditions: Erectile Dysfunction, Benign Prostatic Hyperplasia
Keywords: Erectile Dysfunction, Benign Prostatic Hyperplasia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 606 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 4 Mar 2009 (estimated)
Results: Posted 30 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Tadalafil 2.5 mg	Experimental	Drug: Tadalafil
Tadalafil 5 mg	Experimental	Drug: Tadalafil
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 45 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TadalafilAlso: Cialis, LY450190tablet once daily by mouth for 12 weeks.	Drug	Tadalafil 2.5 mg, Tadalafil 5 mg
PlaceboMatching 2.5 or 5 mg placebo tablet once daily by mouth for 12 weeks.	Drug	Placebo

Primary outcome

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg)
Time frame: Baseline, 12 weeks
The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg)
Time frame: Baseline, 12 weeks
Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg)
Time frame: Baseline, 12 weeks
The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg)
Time frame: Baseline, 12 weeks
Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

26 secondary outcomes

Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg)
Time frame: Baseline, 12 weeks
Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg)
Time frame: Baseline, 12 weeks
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)
Time frame: Baseline, 12 weeks
Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg)
Time frame: Baseline, 12 weeks
Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint
Time frame: Baseline, 2 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint
Time frame: Baseline, 4 weeks, 8 weeks
Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain at Week 4 and Week 8 Endpoint
Time frame: Baseline, 4 weeks, 8 weeks
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 4 and Week 8 Endpoint
Time frame: Baseline, 4 weeks, 8 weeks
Change From Baseline in BPH Impact Index (BII) at Week 4 and 8 Endpoint
Time frame: Baseline, 4 weeks, 8 weeks
Change From Baseline in International Prostate Symptom Score Voiding (Obstructive) Subscore at Week 12 Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score Storage (Irritative) Subscore at Week 12 Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score Nocturia Question at Week 12
Time frame: Baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score Quality of Life (QoL) at Week 12 Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in International Index of Erectile Function - Overall Satisfaction Domain at Week 12 Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in International Index of Erectile Function - Intercourse Satisfaction Domain at Week 12 Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in International Index of Erectile Function Question 3 at Week 12 Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in International Index of Erectile Function Question 4 at Week 12 Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 2 at Week 12 Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 4 at Week 12 Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 5
Time frame: Baseline, 12 weeks
Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint
Time frame: 12 weeks
Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint
Time frame: 12 weeks
Erectile Function General Assessment Questionnaire (EF-GAQ)
Time frame: 12 weeks
Change From Baseline in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) at Week 12 Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in Uroflowmetry Parameters - Mean Urine Flow Rate (Qmean) at Week 12 Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in Uroflowmetry Parameters - Voided Volume (Vcomp) at Week 12 Endpoint
Time frame: Baseline, 12 weeks

Results and safety

Results posted to the registry on 30 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tadalafil 2.5 mg	198	172
Tadalafil 5 mg	208	184
Placebo	200	170

Primary outcome: Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg)

Time frame: Baseline, 12 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Tadalafil 5 mg n = 206	Placebo n = 194
Value	-6.1 (0.43)	-3.8 (0.45)

Tadalafil 5 mg vs Placebo: Median Difference (Final Values): -2.3, p <0.001, ANCOVA

Population analysed: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).

Primary outcome: Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg)

Time frame: Baseline, 12 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Tadalafil 5 mg n = 203	Placebo n = 190
Value	6.5 (0.49)	1.8 (0.51)

Tadalafil 5 mg vs Placebo: Mean Difference (Final Values): 4.7, p <0.001, ANCOVA

Population analysed: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).

Primary outcome: Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg)

Time frame: Baseline, 12 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Tadalafil 2.5 mg n = 191	Placebo n = 194
Value	-4.6 (0.44)	-3.8 (0.45)

Tadalafil 2.5 mg vs Placebo: Mean Difference (Final Values): -0.8, p = 0.181, ANCOVA

Population analysed: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).

Primary outcome: Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg)

Time frame: Baseline, 12 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Tadalafil 2.5 mg n = 190	Placebo n = 190
Value	5.2 (0.5)	1.8 (0.51)

Tadalafil 2.5 mg vs Placebo: Mean Difference (Final Values): 3.4, p <0.001, ANCOVA

Population analysed: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).

26 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tadalafil 2.5 mg	2 of 198 (1%)	50 of 198 (25.3%)	Not reported
Tadalafil 5 mg	1 of 208 (0.5%)	56 of 208 (26.9%)	Not reported
Placebo	1 of 200 (0.5%)	38 of 200 (19%)	Not reported

Limitations and caveats (from the sponsor): P-values for the peak urine flow rate outcome were corrected in this record after an error was identified.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26299520Vlachopoulos 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.
Derived from this study: PubMed 24119319Porst 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

52 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tadalafil in people with Erectile Dysfunction and Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 52 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, France, Canada, Greece, Mexico and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg) (time frame: Baseline, 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00855582, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2011.