Study to Determine a Preference Between Sildenafil or Tadalafil Treatment for Problems Getting an Erection

NCT00547352 | Completed Phase 4

• 2 other identifiers: 9152H6D-KL-S002
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if men with problems getting and keeping an erection prefer treatment with tadalafil or sildenafil.

Conditions

Impotence

Outcome Measures

Primary Outcomes (1)

• Patient choice of drug at visit 5

  14-15 weeks

Secondary Outcomes (1)

• PAIRS self-administered scale scores

  14-15 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

sildenafil treatment for at least 10 weeks prior to a 1 week wash out

Drug: sildenafil

2

ACTIVE COMPARATOR

Tadalafil treatment for 8 weeks following the 1 week washout period.

Drug: tadalafil

Interventions

tadalafil DRUG

20 mg tadalafil tablets taken by mouth, as needed, no more than once a day for 8 weeks.

Also known as: LY450190, Cialis, IC351

2

sildenafil DRUG

Current users of sildenafil citrate for a minimum of 6 weeks prior to visit 1 will continue with an individual dosage to be taken no more than once a day for an additional 4 weeks.

1

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
• Anticipate a monogamous female sexual relationship
• Abstain from other erection treatments throughout the study
• Currently use sildenafil

You may not qualify if:

• Other primary sexual disorders
• History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
• History of penile implant or clinically significant penile deformity.
• Nitrate use
• Certain heart problems

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.

Seoul, South Korea

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
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 18, 2007
• First Posted: October 22, 2007
• Study Start: June 1, 2004
• Study Completion: June 1, 2005
• Last Updated: October 22, 2007

Record last verified: 2007-10

Locations

KR (1)