Brief Summary

The purpose of this trial is to evaluate if treatment with tadalafil once daily will allow men to return to normal erectile function in those who did not have normal erectile function following as-needed (PRN) Phosphodiesterase Type 5 (PDE5) Inhibitor treatment.

Trial Health

On Track

Trial Health Score

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

Enrollment

623

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Aug 2010

Geographic Reach

2 countries

40 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

1.4 years study duration

First Submitted

Initial submission to the registry

May 24, 2010

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed

2 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed

1 year until next milestone

Results Posted

Study results publicly available

January 4, 2013

Completed

Last Updated

January 4, 2013

Status Verified

December 1, 2012

Enrollment Period

1.4 years

First QC Date

May 24, 2010

Results QC Date

December 3, 2012

Last Update Submit

December 3, 2012

Conditions

Erectile Dysfunction

Keywords

Erectile DysfunctionEDImpotence

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period)
Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of double-blind treatment period (Period III).
Baseline through 12 weeks

Secondary Outcomes (12)

Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score
Baseline, 12 weeks
Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score
Baseline, 12 weeks
Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score
Baseline, 12 weeks
Change From Baseline to 12-Week in Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 1-5
Baseline, 12 weeks
Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient
Baseline, 12 weeks
+7 more secondary outcomes

Study Arms (3)

2.5 milligram (mg) titrated to 5 mg Tadalafil

ACTIVE COMPARATOR

2.5 mg for 4 weeks, followed by 5 mg for 8 weeks with option to continue treatment at 5 mg for an additional 4 weeks

Drug: Tadalafil

5 mg Tadalafil

ACTIVE COMPARATOR

5.0 mg for 12 weeks with option to continue treatment for additional 4 weeks

Drug: Tadalafil

Placebo

PLACEBO COMPARATOR

for 12 weeks

Drug: Placebo

Interventions

TadalafilDRUG

Administer orally

Also known as: Cialis, LY450190

2.5 milligram (mg) titrated to 5 mg Tadalafil5 mg Tadalafil

PlaceboDRUG

Administer orally

Placebo

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

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

You may qualify if:

At least a 3-month history of erectile dysfunction (ED).
Are able to read, understand and provide signed informed consent.
Have an International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is greater than or equal to 17 and less than 26 at screening.
Have been taking a maximum dose of sildenafil citrate (100 milligram \[mg\]), vardenafil (20 mg), or tadalafil (20 mg) on as needed basis for at least one month prior to screening.
Anticipate having the same female sexual partner during the study who is willing to participate in the required number of sexual intercourse attempts and complete study measures during the study.
Agree to make at least four sexual intercourse attempts during both the 4-week as needed run-in period and the 4-week non-drug run-in period.
Agree not to use any other erectile dysfunction (ED) treatment, including herbal therapy during the 4-week non-drug, run-in, the double-blind treatment period, the open label period and for 96 hours after the end of the study.
Are female and at least 18 years of age at screening.
Anticipate having the same male study subject as her sexual partner during the study.
Able to read, understand and provide signed informed consent.
Agree to make the required number of sexual intercourse attempts with the male sexual study partner during the study.
Willing to participate in recording responses to the treatment satisfaction scale.

You may not qualify if:

Have an IIEF-EF domain score of greater than or equal to 26 at screening.
Prior ineffective treatment with (or nonresponder to) any PDE5 Inhibitor
Have previously used or are currently using any PDE5 inhibitor once daily.
Present with ED caused by other primary disorders or ED caused by untreated/inadequately treated endocrine disease.
Partner unwilling to complete all study requirements.
History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator
Exhibit evidence of clinically significant renal insufficiency or hepatobiliary disease, or significant cardiac history as determined by the investigator
Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens
Have previously completed or withdrawn from this study or any other study investigating tadalafil for once-daily use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (40)

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.

Huntsville, Alabama, 35801, United States

Location

Lancaster, California, 93534, United States

Location

Newport Beach, California, 92660, United States

Location

San Diego, California, 92103, United States

Location

Spring Valley, California, 91978, United States

Location

Tarzana, California, 91356, United States

Location

New Britain, Connecticut, 06052, United States

Location

Aventura, Florida, 33180, United States

Location

Fort Lauderdale, Florida, 33316, United States

Location

Oviedo, Florida, 32765, United States

Location

Meridian, Idaho, 83646, United States

Location

Nampa, Idaho, 83686, United States

Location

Lansing, Kansas, 66043, United States

Location

Topeka, Kansas, 66606, United States

Location

Haverhill, Massachusetts, 01830, United States

Location

Troy, Michigan, 48085, United States

Location

Toms River, New Jersey, 08753, United States

Location

Garden City, New York, 11530, United States

Location

Poughkeepsie, New York, 12601, United States

Location

Concord, North Carolina, 28025, United States

Location

Wilmington, North Carolina, 28401, United States

Location

Fargo, North Dakota, 58103, United States

Location

Lyndhurst, Ohio, 44124, United States

Location

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Anderson, South Carolina, 29621, United States

Location

Greer, South Carolina, 29651, United States

Location

Mt. Pleasant, South Carolina, 29464, United States

Location

Knoxville, Tennessee, 37920, United States

Location

Austin, Texas, 78731, United States

Location

San Antonio, Texas, 78258, United States

Location

Clinton, Utah, 84015, United States

Location

Bellevue, Washington, 98007, United States

Location

Seattle, Washington, 98166, United States

Location

Spokane, Washington, 99220, United States

Location

Langley, British Columbia, V3A 4H9, Canada

Location

Victoria, British Columbia, V8T 5G1, Canada

Location

Burlington, Ontario, L7N 3V2, Canada

Location

North York, Ontario, M3B 3S6, Canada

Location

Montreal, Quebec, H2X 1N8, Canada

Location

Saskatoon, Saskatchewan, S7K 7H9, Canada

Location

Related Publications (2)

Kim E, Seftel A, Goldfischer E, Baygani S, Burns P. Comparative efficacy of tadalafil once daily in men with erectile dysfunction who demonstrated previous partial responses to as-needed sildenafil, tadalafil, or vardenafil. Curr Med Res Opin. 2015 Feb;31(2):379-89. doi: 10.1185/03007995.2014.989317. Epub 2014 Dec 2.
PMID: 25455432DERIVED
Kim ED, Seftel AD, Goldfischer ER, Ni X, Burns PR. A return to normal erectile function with tadalafil once daily after an incomplete response to as-needed PDE5 inhibitor therapy. J Sex Med. 2014 Mar;11(3):820-30. doi: 10.1111/jsm.12253. Epub 2013 Jul 10.
PMID: 23841532DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title: Chief Medical Officer
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 4
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 24, 2010

First Posted

May 26, 2010

Study Start

August 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 4, 2013

Results First Posted

January 4, 2013

Record last verified: 2012-12

Locations

CA(6)US(34)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (3)

2.5 milligram (mg) titrated to 5 mg Tadalafil

5 mg Tadalafil

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (40)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations