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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 19, 2014