Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection

NCT00547092 | Completed Phase 4

• 2 other identifiers: 7002H6D-MC-LVFL
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.

Conditions

Impotence

Outcome Measures

Primary Outcomes (1)

• Preference Assessment measured by the Treatment Preference Question

  26 weeks

Secondary Outcomes (3)

• Compare efficacies of the two drugs as measured by the Erectile Function domain of IIEF and Questions 2 and 3 of the SEP diary.

  0, 12, and 26 weeks

• Assess sexual encounters attributes measured by the PAIRS.

  0, 12, and 26 weeks

• Measure adverse events through the Side Effect Question.

  12 and 26 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

tadalafil given the first 12 weeks and after a 4 week washout sildenafil is given for 12 weeks.

Drug: tadalafil

2

ACTIVE COMPARATOR

sildenafil given the first 12 weeks and after a 4 week washout tadalafil is given for 12 weeks.

Drug: sildenafil

Interventions

tadalafil DRUG

10 mg or 20 mg tadalafil tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)

Also known as: LY450190, Cialis, IC351

1

sildenafil DRUG

25 mg, 50 mg, or 100 mg sildenafil citrate tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of erection problems
• Never taken treatments known as PDE5 inhibitors for erection issues
• Abstain from using any other erection treatments during the study
• Anticipate a monogamous female sexual relationship
• Must be able to make required sexual intercourse attempts

You may not qualify if:

• History of other primary sexual disorder
• Treatment with nitrates
• Have a penile implant or clinically significant penile deformity
• History of certain heart problems
• Do not meet certain lab value reference ranges

Sponsors & Collaborators

• Eli Lilly and Company: lead
• ICOS Corporation: collaborator

Study Sites (1)

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.

Plymouth, United Kingdom

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil; Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Purines

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 18, 2007
• First Posted: October 22, 2007
• Study Start: October 1, 2003
• Study Completion: November 1, 2004
• Last Updated: October 22, 2007

Record last verified: 2007-10

Locations

GB (1)