Brief Summary

The purpose of this study is to investigate if treatment in erectile dysfunction with a long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer treatment adherence and better long term outcomes (over 24 weeks), compared with a short-acting drug (Sildenafil Citrate) taken as needed.

Trial Health

On Track

Trial Health Score

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

Enrollment

770

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started May 2010

Shorter than P25 for phase_4

Geographic Reach

8 countries

45 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

1.1 years study duration

Study Start

First participant enrolled

May 1, 2010

Completed

4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2010

Completed

8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

October 19, 2012

Completed

Last Updated

October 19, 2012

Status Verified

September 1, 2012

Enrollment Period

1.1 years

First QC Date

May 5, 2010

Results QC Date

June 11, 2012

Last Update Submit

September 18, 2012

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

Time to Discontinuation of Randomized Treatment
Time to discontinuation of randomized treatment was defined as the number of days from randomization until the day the participant discontinued the randomized treatment. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered switching of treatment. This outcome measure was estimated using the Kaplan-Meier product-limit method.
Baseline up to 334 days

Secondary Outcomes (17)

Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain
Baseline, 4, 8, 16, and 24 weeks
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Orgasmic Function Domain
Baseline, 4, 8, 16, and 24 weeks
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Sexual Desire Domain
Baseline, 4, 8, 16, and 24 weeks
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Baseline, 4, 8, 16, and 24 weeks
Global Assessment Questions (GAQ)
24 weeks
+12 more secondary outcomes

Study Arms (3)

Tadalafil on demand

EXPERIMENTAL

10 milligrams (mg) or 20 mg on demand

Drug: Tadalafil

Tadalafil once a day

EXPERIMENTAL

5 mg or 2.5 mg once a day

Drug: Tadalafil

Sildenafil Citrate

ACTIVE COMPARATOR

50 mg, 100 mg, or 25 mg on demand

Drug: Sildenafil Citrate

Interventions

TadalafilDRUG

Administered orally for 24 weeks.

Also known as: Cialis, LY450190

Tadalafil on demandTadalafil once a day

Sildenafil CitrateDRUG

Administered orally for 24 weeks.

Sildenafil Citrate

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

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

You may qualify if:

History of Erectile Dysfunction (ED) of at least 3 months duration.
Anticipate having the same adult female sexual partner during the study.
Agree not to use any other treatment for ED and to participate in recording responses to questionnaires and other instruments used in this study.

You may not qualify if:

Previous or current treatment with tadalafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
ED caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity.
ED caused by untreated or inadequately treated endocrine disease.
Current treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens.
Severe renal or hepatic impairment, history of malignant hypertension.
Presence or history of specific heart conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (45)

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.

Carpentras, 84200, France

Location

Chambéry, 73000, France

Location

La Bouëxière, 35340, France

Location

Lille, 59000, France

Location

Lyon, 69437, France

Location

Marseille, 13009, France

Location

Montpellier, 34090, France

Location

Mûrs-Erigné, 49610, France

Location

Nantes, 44300, France

Location

Rennes, 35 700, France

Location

Toulouse, 31000, France

Location

Giengen an der Brenz, 89537, Germany

Location

Grevenbroich, 41515, Germany

Location

Holzminden, D-37603, Germany

Location

Koblenz, 56068, Germany

Location

Leipzig, 04109, Germany

Location

Leverkusen, 51375, Germany

Location

Lübeck, 23552, Germany

Location

Marburg, 35039, Germany

Location

Mühlacker, D-75417, Germany

Location

Warburg, 34414, Germany

Location

Heraklion, 71110, Greece

Location

Larissa, 41221, Greece

Location

Pátrai, 26500, Greece

Location

Thessaloniki, 56429, Greece

Location

Kutno, 99-300, Poland

Location

Legionowo, 05-120, Poland

Location

Lublin, 20-008, Poland

Location

Warsaw, 00-909, Poland

Location

Wroclaw, 53-532, Poland

Location

Porto, 4202-451, Portugal

Location

Bucharest, 050653, Romania

Location

Cluj-Napoca, 400046, Romania

Location

Alcorcón, 28922, Spain

Location

Aravaca, 28023, Spain

Location

Barcelona, 08025, Spain

Location

Coslada, 28820, Spain

Location

Gijón, Spain

Location

Madrid, 28040, Spain

Location

Málaga, 29007, Spain

Location

San Sebastián de los Reyes, 28702, Spain

Location

Vigo, 36211, Spain

Location

Fowey, Cornwall, PL23 1DT, United Kingdom

Location

Durham, County Durham, DH1 2QW, United Kingdom

Location

Plymouth, Devon, PL6 7TH, United Kingdom

Location

Related Publications (1)

Buvat J, Buttner H, Hatzimouratidis K, Vendeira PA, Moncada I, Boehmer M, Henneges C, Boess FG. Adherence to initial PDE-5 inhibitor treatment: randomized open-label study comparing tadalafil once a day, tadalafil on demand, and sildenafil on demand in patients with erectile dysfunction. J Sex Med. 2013 Jun;10(6):1592-602. doi: 10.1111/jsm.12130. Epub 2013 Apr 2.
PMID: 23551622DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

TadalafilSildenafil Citrate

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-RingSulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesPurines

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: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 5, 2010

First Posted

May 13, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

October 19, 2012

Results First Posted

October 19, 2012

Record last verified: 2012-09

Locations

FR(11)DE(10)PL(5)RO(2)ES(9)GB(3)GR(4)PT(1)

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 (1)

Secondary Outcomes (17)

Study Arms (3)

Tadalafil on demand

Tadalafil once a day

Sildenafil Citrate

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (45)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations