Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life
- Registration Number
- NCT00422734
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexual quality of life of the man and his female study partner
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 342
Male
- History of erectile dysfunction (ED) for at least 3 months duration
- Anticipate having the same female partner willing to participate throughout the study
- At least 18 years of age at Visit 1 and agree to make at least 4 sexual attempts during the early phase of the study
- Adequate partner sexual function as determined by a Female Sexual Function Index
- Willing to record responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in the study
- May not participate in the study if you have taken tadalafil previously.
- History of cardiac conditions including angina requiring treatment with nitrates, heart disease of coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for specified time before starting the study.
- Have sexual partner not willing to complete the scales.
- Use of nitrates.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Placebo Placebo 2 tadalafil 5 mg tadalafil
- Primary Outcome Measures
Name Time Method Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15) Baseline and 12 weeks Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.
Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ) Baseline and 12 weeks The original item scores (-4 to 4 range) were converted to 0 to 8 scale score by adding 4 to each recorded responses. Each transformed score was multiplied by 12.5 for a total range of 0 to 100. Higher scores are indicative of a higher sexual quality of life.
Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3). Baseline and 12 weeks The baseline and endpoint score for each SEP question 2 (Insert penis into vagina) and 3 (Successful intercourse) are the subject's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response Baseline and 12 weeks Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.
Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response Baseline and 12 weeks Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.
Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain 12 weeks The 6 SLQQ-treatment satisfaction questions were answered by subject and partner at Visit 4/Final Visit. Original item scores (1 to 6 range) were converted to 0 to 5 scale by subtracting 1 to each recorded responses. Each transformed score was multiplied by 20. Total range of scores: 0 (low satisfaction) to 100 (high satisfaction).
Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response Baseline and 12 weeks The baseline and endpoint score for each SEP question 4 (Satisfied with hardness) and 5 (Satisfied overall) are the subject's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.
Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response Baseline and 12 weeks The baseline and endpoint score for partner SEP question 3 (Satisfied overall) are the partner's percentage of "yes" responses to the question during the run-in period and postbaseline period, respectively.
Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response Baseline and 12 weeks The FSFI Satisfaction Domain (items 14-16) measures satisfaction with emotional closeness, sexual relationship, and overall sexual life. Each question is scored on a 0/1 to 5 scale and domain score is calculated by multiplying the total points by 0.4, for a total score range of 0.8 to 6, with higher scores indicating greater satisfaction.
Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response 12 weeks Percent of subjects with "Yes" responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)
Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response 12 weeks Percent of Partners with "Yes" responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)
Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response Baseline and 12 weeks The baseline and endpoint score for each SEP question 1 (Achieve some erection) and 2 (Insert penis into vagina) are the partner's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.
Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire Baseline and 12 weeks Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.
Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales Baseline and 12 weeks Measures improvement in confidence (items 9-14). Confidence domain consists of two subscales (Self-Esteem, items 9-12; Overall Relationship, items 13 and 14). Each domain score, subscale score, and overall score are transformed onto a 0 (least favorable) to 100 (most favorable) scale.
Trial Locations
- Locations (1)
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.
🇲🇽La Joya, Mexico