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Sponsors and Collaborators: |
Eli Lilly and Company ICOS Corporation |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00547183 |
Study to evaluate the safety and effectiveness of 2.5 mg and 5 mg tadalafil when taken by men with diabetes mellitus who have problems getting and maintaining an erection.
Condition | Intervention | Phase |
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Impotence |
Drug: tadalafil Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Parallel-Design, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5 mg and 5 mg) Administered Once Daily to Men With Diabetes Mellitus and Erectile Dysfunction |
Enrollment: | 298 |
Study Start Date: | October 2004 |
Study Completion Date: | May 2005 |
Arms | Assigned Interventions |
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2: Active Comparator
2.5 mg tadalafil
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Drug: tadalafil
2.5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
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3: Active Comparator
5 mg tadalafil
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Drug: tadalafil
5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
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1: Placebo Comparator |
Drug: placebo
Placebo tablet taken by mouth once a day, no more than 1 dose per day, for 12 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
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. | |
Genthin, Germany |
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 |
Study ID Numbers: | 8702, H6D-MC-LVFZ |
Study First Received: | October 18, 2007 |
Last Updated: | October 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00547183 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Sexual Dysfunctions, Psychological Phosphodiesterase Inhibitors Sexual Dysfunction, Physiological Mental Disorders |
Tadalafil Diabetes Mellitus Genital Diseases, Male Erectile Dysfunction |
Sexual Dysfunctions, Psychological Phosphodiesterase Inhibitors Sexual Dysfunction, Physiological Molecular Mechanisms of Pharmacological Action Mental Disorders Tadalafil |
Enzyme Inhibitors Genital Diseases, Male Sexual and Gender Disorders Erectile Dysfunction Pharmacologic Actions |