A Study of Tadalafil and Sildenafil in Men With Erectile Dysfunction in China
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ClinicalTrials.gov Identifier: NCT01352507 |
Recruitment Status :
Completed
First Posted : May 12, 2011
Results First Posted : April 26, 2013
Last Update Posted : April 26, 2013
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Erectile Dysfunction |
Interventions |
Drug: Tadalafil Drug: Sildenafil |
Enrollment | 383 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Tadalafil Then Sildenafil | Sildenafil Then Tadalafil |
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20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments. At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED). |
100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments. At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED. |
Period Title: Treatment Period 1 | ||
Started | 190 | 193 |
Received Treatment | 182 | 188 |
Completed | 176 | 184 |
Not Completed | 14 | 9 |
Reason Not Completed | ||
Adverse Event | 3 | 0 |
Lost to Follow-up | 3 | 4 |
Withdrawal by Subject | 7 | 5 |
Physician Decision | 1 | 0 |
Period Title: Washout Period | ||
Started | 176 | 184 |
Completed | 176 | 183 |
Not Completed | 0 | 1 |
Reason Not Completed | ||
Withdrawal by Subject | 0 | 1 |
Period Title: Treatment Period 2 | ||
Started | 176 | 183 |
Received Treatment | 173 | 181 |
Completed | 170 [1] | 180 [2] |
Not Completed | 6 | 3 |
Reason Not Completed | ||
Entry Criteria Not Met | 1 | 0 |
Withdrawal by Subject | 4 | 3 |
Lack of Efficacy | 1 | 0 |
[1]
Six participants who completed Treatment Period 2 chose not to enter the Extension Phase.
[2]
Seven participants who completed Treatment Period 2 chose not to enter the Extension Phase.
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Period Title: Extension Phase | ||
Started | 164 | 173 |
Completed | 164 | 173 |
Not Completed | 0 | 0 |
Arm/Group Title | Tadalafil Then Sildenafil | Sildenafil Then Tadalafil | Total | |
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20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments. At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED). |
100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments. At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 190 | 193 | 383 | |
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All randomized participants.
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 190 participants | 193 participants | 383 participants | |
39.20 (10.52) | 40.66 (11.44) | 39.94 (11.00) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 190 participants | 193 participants | 383 participants | |
Female |
0 0.0%
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0 0.0%
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0 0.0%
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Male |
190 100.0%
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193 100.0%
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383 100.0%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
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Chinese | Number Analyzed | 190 participants | 193 participants | 383 participants |
190 | 193 | 383 | ||
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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China | Number Analyzed | 190 participants | 193 participants | 383 participants |
190 | 193 | 383 | ||
International Index of Erectile Function (IIEF) Erectile Function (EF) Domain
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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Number Analyzed | 190 participants | 193 participants | 383 participants | |
13.77 (5.37) | 14.19 (6.08) | 13.98 (5.73) | ||
[1]
Measure Description: IIEF-EF was the sum of Questions (Q)1 through 5 and Q15 of the IIEF. Q1 to Q5 were scored 0 (low/no erectile function) to 5 (high erectile function) and Q15 was scored 1 (no/low confidence) to 5 (high confidence). IIEF-EF domain scores ranged from 1 to 30. Higher scores represented better erectile function.
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Erectile Dysfunction (ED) Severity
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 190 participants | 193 participants | 383 participants |
Mild | 63 | 68 | 131 | |
Moderate | 68 | 65 | 133 | |
Severe | 59 | 60 | 119 | |
[1]
Measure Description: Investigator-reported severity of a participant's ED. ED was defined as a consistent change in the quality of erection adversely affecting participant satisfaction with sexual intercourse. Severity was based on investigator opinion.
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ED Duration
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 190 participants | 193 participants | 383 participants |
≥3 months to <1 year | 77 | 87 | 164 | |
≥1 year | 113 | 106 | 219 | |
ED Etiology
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 190 participants | 193 participants | 383 participants |
Psychogenic | 46 | 41 | 87 | |
Organic | 11 | 13 | 24 | |
Mixed | 133 | 139 | 272 |
Name/Title: | Chief Medical Officer |
Organization: | Eli Lilly and Company |
Phone: | 800-545-5979 |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT01352507 |
Other Study ID Numbers: |
14035 H6D-CR-LVIZ ( Other Identifier: Eli Lilly and Company ) |
First Submitted: | May 10, 2011 |
First Posted: | May 12, 2011 |
Results First Submitted: | March 13, 2013 |
Results First Posted: | April 26, 2013 |
Last Update Posted: | April 26, 2013 |