NCT00855582|CompletedPhase 3Results

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

COMORBID©

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

Eli Lilly and Company ClinicalTrials.gov

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2 other identifiers

11667H6D-MC-LVHR

Study Type

interventional

Target

606

Locations

9 countries

Sites

Timeline

RegisteredMar 2009

StartedMar 2009

CompletionJul 2010

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 benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

606

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Mar 2009

Shorter than P25 for phase_3

Geographic Reach

9 countries

52 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

March 1, 2009

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed

12 months until next milestone

Results Posted

Study results publicly available

June 30, 2011

Completed

Last Updated

July 28, 2011

Status Verified

July 1, 2011

Enrollment Period

1.3 years

First QC Date

March 3, 2009

Results QC Date

June 1, 2011

Last Update Submit

July 26, 2011

Conditions

Erectile Dysfunction Benign Prostatic Hyperplasia

Keywords

Erectile DysfunctionBenign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (4)

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.
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.
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.
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.
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)
Baseline, 12 weeks
Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg)
Baseline, 12 weeks
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)
Baseline, 12 weeks
Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg)
Baseline, 12 weeks
Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint
Baseline, 2 weeks
+21 more secondary outcomes

Study Arms (3)

Tadalafil 2.5 mg

EXPERIMENTAL

Drug: Tadalafil

Tadalafil 5 mg

EXPERIMENTAL

Drug: Tadalafil

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TadalafilDRUG

tablet once daily by mouth for 12 weeks.

Also known as: Cialis, LY450190

Tadalafil 2.5 mgTadalafil 5 mg

PlaceboDRUG

Matching 2.5 or 5 mg placebo tablet once daily by mouth for 12 weeks.

Placebo

Eligibility Criteria

Age45 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
+4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (52)

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, United States

Location

Phoenix, Arizona, 85050, United States

Location

La Mesa, California, 91942, United States

Location

Los Angeles, California, 90017, United States

Location

Newport Beach, California, 92660, United States

Location

San Diego, California, 92120, United States

Location

Tarzana, California, 91356, United States

Location

Englewood, Colorado, 80113, United States

Location

Urbana, Illinois, 61801, United States

Location

West Des Moines, Iowa, 50266, United States

Location

Minneapolis, Minnesota, 55455, United States

Location

Missoula, Montana, 59802, United States

Location

Edmond, Oklahoma, 73034, United States

Location

Dallas, Texas, 75231, United States

Location

San Antonio, Texas, 78229, United States

Location

Mountlake Terrace, Washington, 98043, United States

Location

Spokane, Washington, 99202, United States

Location

Surrey, British Columbia, V3V 1N1, Canada

Location

Victoria, British Columbia, V8V 3N1, Canada

Location

Saint John, New Brunswick, E2L 3J8, Canada

Location

Barrie, Ontario, L4M 7G1, Canada

Location

Kitchener, Ontario, N2N 3B9, Canada

Location

Carpentras, 84200, France

Location

Lyon, 69437, France

Location

Nice, 06002, France

Location

Nîmes, 30029, France

Location

Orléans, 45067, France

Location

Toulouse, 31059, France

Location

Bad Rappenau, 74906, Germany

Location

Frankfurt, D-65933, Germany

Location

Holzminden, D-37603, Germany

Location

Kempen, 47906, Germany

Location

Athens, 11527, Greece

Location

Heraklion, 71110, Greece

Location

Larissa, 41221, Greece

Location

Pátrai, 26500, Greece

Location

Thessaloniki, 56429, Greece

Location

Genova, 16132, Italy

Location

Milan, 20132, Italy

Location

Sassari, 07100, Italy

Location

Trieste, 31149, Italy

Location

Colima, 28000, Mexico

Location

Durango, 34000, Mexico

Location

La Joya, 14000, Mexico

Location

Mexico City, 14050, Mexico

Location

Morelia, 58000, Mexico

Location

Amadora, 2700-351, Portugal

Location

Coimbra, 3000-075, Portugal

Location

Lisbon, 1250-203, Portugal

Location

Porto, 4202-451, Portugal

Location

Moscow, 119435, Russia

Location

Rostov-on-Don, 344011, Russia

Location

Related Publications (2)

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.
PMID: 26299520DERIVED
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.
PMID: 24119319DERIVED

MeSH Terms

Conditions

Erectile DysfunctionProstatic Hyperplasia

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersProstatic Diseases

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Limitations and Caveats

P-values for the peak urine flow rate outcome were corrected in this record after an error was identified.

Results Point of Contact

Title: Chief Medical Office
Organization: Eli Lilly and Company

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 4, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

July 28, 2011

Results First Posted

June 30, 2011

Record last verified: 2011-07

Locations

PT(4)RU(2)CA(5)ME(5)IT(4)US(17)DE(4)GR(5)FR(6)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (26)

Study Arms (3)

Tadalafil 2.5 mg

Tadalafil 5 mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (52)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations