A Comparison of Psychosocial Outcomes Following Tadalafil Once a Day or PDE5 Inhibitor As Needed in Men With Erectile Dysfunction.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)
研究概览
简要总结
The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •History of erectile dysfunction (ED).
- •Have had satisfactory response to tadalafil, sildenafil citrate, or vardenafil HCl for a period of at least 6 months and expect frequent use (at least one dose per week, on average) when administered as needed.
- •Have never used tadalafil 5 mg or 2.5 mg once a day therapy.
- •Anticipate having the same adult female sexual partner willing to participate during the study.
- •Agree to make at least four sexual intercourse attempts during the first four weeks of the study.
- •Agree not to use any other treatment for ED (even herbal treatments) during the study.
- •Agree to follow the directions given by the study doctor and staff about using the study drug.
排除标准
- •Have any other primary sexual disorders present or penile deformity.
- •Have history of radical prostatectomy or penile implant.
- •Have problems with your kidneys, liver, or nervous system.
- •Have uncontrolled diabetes, as measured by a blood test for haemoglobin A1C greater than a value of 11%.
- •Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin).
- •Have chest pain (called unstable angina or angina) that requires treatment.
- •Have heart disease that causes symptoms after you exert yourself.
- •Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
- •Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION).
- •Have retinitis pigmentosa.
- •Have history of human immunodeficiency virus (HIV).
- •Have very high or very low blood pressure (your study doctor will discuss the limits with you).
- •Have had a stroke or a significant injury to your brain or spinal cord within the last 6 months.
- •Have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Lactose intolerance.
- •Have a scheduled or planned surgery requiring anaesthesia during the course of the study.
- •Have a scheduled cataract surgery during the curse of the study.
研究组 & 干预措施
T(OaD)/S(PRN)/T(PRN)
Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
干预措施: tadalafil once a day [T(OaD)] (Drug)
T(OaD)/S(PRN)/T(PRN)
Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
干预措施: sildenafil citrate as needed [S(PRN)] (Drug)
T(OaD)/S(PRN)/T(PRN)
Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
干预措施: tadalafil as needed [T(PRN)] (Drug)
T(OaD)/T(PRN)/S(PRN)
Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
干预措施: tadalafil once a day [T(OaD)] (Drug)
T(OaD)/T(PRN)/S(PRN)
Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
干预措施: sildenafil citrate as needed [S(PRN)] (Drug)
T(OaD)/T(PRN)/S(PRN)
Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
干预措施: tadalafil as needed [T(PRN)] (Drug)
S(PRN)/T(OaD)/T(PRN)
Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
干预措施: tadalafil once a day [T(OaD)] (Drug)
S(PRN)/T(OaD)/T(PRN)
Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
干预措施: sildenafil citrate as needed [S(PRN)] (Drug)
S(PRN)/T(OaD)/T(PRN)
Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
干预措施: tadalafil as needed [T(PRN)] (Drug)
S(PRN)/T(PRN)/T(OaD)
Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
干预措施: tadalafil once a day [T(OaD)] (Drug)
S(PRN)/T(PRN)/T(OaD)
Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
干预措施: sildenafil citrate as needed [S(PRN)] (Drug)
S(PRN)/T(PRN)/T(OaD)
Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
干预措施: tadalafil as needed [T(PRN)] (Drug)
T(PRN)/T(OaD)/S(PRN)
Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
干预措施: tadalafil once a day [T(OaD)] (Drug)
T(PRN)/T(OaD)/S(PRN)
Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
干预措施: sildenafil citrate as needed [S(PRN)] (Drug)
T(PRN)/T(OaD)/S(PRN)
Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
干预措施: tadalafil as needed [T(PRN)] (Drug)
T(PRN)/S(PRN)/T(OaD)
Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
干预措施: tadalafil once a day [T(OaD)] (Drug)
T(PRN)/S(PRN)/T(OaD)
Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
干预措施: sildenafil citrate as needed [S(PRN)] (Drug)
T(PRN)/S(PRN)/T(OaD)
Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
干预措施: tadalafil as needed [T(PRN)] (Drug)
结局指标
主要结局
Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)
时间窗: baseline, 8 weeks of each treatment
The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.
次要结局
- Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)(baseline, 8 weeks of each treatment)
- Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS(baseline, 8 weeks of each treatment)
- Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS(baseline, 8 weeks of each treatment)
- Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)(baseline, 8 weeks of each treatment)
- Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection(baseline, 8 weeks of each treatment)
- Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF(baseline, 8 weeks of each treatment)
- Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF(baseline, 8 weeks of each treatment)
- Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint(8 weeks of each treatment)
- Number of Participants With at Least One Serious Adverse Event(baseline through 26 weeks (including two washout periods of 1 week each))
- Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score(baseline, 8 weeks of each treatment)
- Question 1 "I Felt as if I Did Not Have ED" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint(8 weeks of each treatment)
- Question 3 "I Felt the Drug Was in Control of my Erections" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint(8 weeks of each treatment)
- Question 2 "I Felt in Control of my Sex Life" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint(8 weeks of each treatment)
- Question 4 "I Felt Like a Whole Man" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint(8 weeks of each treatment)