Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection

This study has been completed.
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00547573
First received: October 18, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection.


Condition Intervention Phase
Impotence
Drug: tadalafil
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multinational, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil Administered "On Demand" to Asian Men With Erectile Dysfunction

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • IIEF Erectile Function Domain score from Questions 1-5 and 15. SEP Diary responses to Questions 2-3 and the entire Diary for baseline and endpoint scores. [ Time Frame: 4, 8, and 12 weeks ]

Secondary Outcome Measures:
  • IIEF questions and scores, Global Assessment Questions, Patient's SEP Diary [ Time Frame: 12 weeks ]

Enrollment: 367
Study Start Date: April 2003
Study Completion Date: December 2003
Arms Assigned Interventions
Active Comparator: 2
10 mg tadalafil tablet
Drug: tadalafil
10 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
Other Names:
  • LY450190
  • Cialis
  • IC351
Active Comparator: 3
20 mg tadalafil tablet
Drug: tadalafil
20 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
Other Names:
  • LY450190
  • Cialis
  • IC351
Placebo Comparator: 1
placebo tablet
Drug: placebo
placebo tablet taken by mouth as needed for 12 weeks not more than once a day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of erection problems
  • Anticipate a monogamous female sexual relationship
  • Abstain from other erection treatments at least 4 weeks before first dose and throughout the study
  • Must be able to make required sexual intercourse attempts

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547573

Locations
China
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 to your personal physician.
Beijing, China
Sponsors and Collaborators
Eli Lilly and Company
ICOS Corporation
Investigators
Study Director: 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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00547573     History of Changes
Other Study ID Numbers: 5874, H6D-MC-LVDY
Study First Received: October 18, 2007
Last Updated: October 18, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Tadalafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014