A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction
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ClinicalTrials.gov Identifier: NCT00381732 |
Recruitment Status :
Completed
First Posted : September 28, 2006
Last Update Posted : November 7, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Erectile Dysfunction | Drug: tadalafil Drug: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 280 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5mg and 5mg) Administered Once Daily to Men With Erectile Dysfunction |
Study Start Date : | October 2003 |
Actual Study Completion Date : | June 2006 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1
placebo tablet
|
Drug: placebo
Placebo tablet taken by mouth once a day for 24 weeks. Placebo patient will receive 5 mg tadalafil tablet during the open label extension. |
Active Comparator: 2
2.5 mg tadalafil tablet
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Drug: tadalafil
2.5 mg or 5 mg tadalafil tablet taken by mouth once a day for 24 weeks. Followed by an open label extension where all patients receive 5 mg doses.
Other Names:
|
Active Comparator: 3
5 mg tadalafil tablet
|
Drug: tadalafil
2.5 mg or 5 mg tadalafil tablet taken by mouth once a day for 24 weeks. Followed by an open label extension where all patients receive 5 mg doses.
Other Names:
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- Changes in erectile function measured at baseline and after 6 months of treatment with 2.5mg and 5mg tadalafil; assessment of safety after 1 and 2 years of therapy with 5mg tadalafil. [ Time Frame: 24-128 weeks ]
- Changes in additional aspects of erectile function after 3 and 6 months of treatment; assessment of the pharmacokinetics of tadalafil 2.5mg and 5mg. [ Time Frame: 24 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men with erectile dysfunction
- At least 18 years of age
Exclusion Criteria:
- Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
- A history of certain impotence disorders
- History of specified pelvic surgery
- Any significant genital abnormality identified at the start of the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381732
United States, Washington | |
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. | |
Bothell, Washington, United States |
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00381732 |
Other Study ID Numbers: |
7019 H6D-MC-LVFP |
First Posted: | September 28, 2006 Key Record Dates |
Last Update Posted: | November 7, 2007 |
Last Verified: | November 2007 |
Impotence erectile dysfunction |
Erectile Dysfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders Tadalafil Vasodilator Agents |
Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents |