NCT01122264已完成4 期
Impact of Tadalafil (LY450190) Once a Day or Tadalafil on Demand Compared to Sildenafil Citrate on Demand on Treatment Discontinuation in Patients With Erectile Dysfunction Who Are naïve to PDE5 Inhibitors
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 770
- 试验地点
- 1
- 主要终点
- Time to Discontinuation of Randomized Treatment
研究概览
简要总结
The purpose of this study is to investigate if treatment in erectile dysfunction with a long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer treatment adherence and better long term outcomes (over 24 weeks), compared with a short-acting drug (Sildenafil Citrate) taken as needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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) of at least 3 months duration.
- •Anticipate having the same adult female sexual partner during the study.
- •Agree not to use any other treatment for ED and to participate in recording responses to questionnaires and other instruments used in this study.
排除标准
- •Previous or current treatment with tadalafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
- •ED caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity.
- •ED caused by untreated or inadequately treated endocrine disease.
- •Current treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens.
- •Severe renal or hepatic impairment, history of malignant hypertension.
- •Presence or history of specific heart conditions.
研究组 & 干预措施
Tadalafil on demand
Experimental
10 milligrams (mg) or 20 mg on demand
干预措施: Tadalafil (Drug)
Tadalafil once a day
Experimental
5 mg or 2.5 mg once a day
干预措施: Tadalafil (Drug)
Sildenafil Citrate
Active Comparator
50 mg, 100 mg, or 25 mg on demand
干预措施: Sildenafil Citrate (Drug)
结局指标
主要结局
Time to Discontinuation of Randomized Treatment
时间窗: Baseline up to 334 days
Time to discontinuation of randomized treatment was defined as the number of days from randomization until the day the participant discontinued the randomized treatment. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered switching of treatment. This outcome measure was estimated using the Kaplan-Meier product-limit method.
次要结局
- Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain(Baseline, 4, 8, 16, and 24 weeks)
- Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Orgasmic Function Domain(Baseline, 4, 8, 16, and 24 weeks)
- Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Sexual Desire Domain(Baseline, 4, 8, 16, and 24 weeks)
- Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)(Baseline, 4, 8, 16, and 24 weeks)
- Global Assessment Questions (GAQ)(24 weeks)
- Number of Treatment Switches(Baseline through 24 weeks)
- Patterns of Erectile Dysfunction Treatment Change(Baseline through 24 weeks)
- Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment(Baseline through 24 weeks)
- Number of Days From the 8-Week Study Visit to the Time the Participant Discontinues From All Phosphodiesterase Type 5 (PDE5) Inhibitor Treatments(8 weeks up to 334 days)
- Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain(Baseline, 4, 8, 16, and 24 weeks)
- Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Overall Satisfaction Domain(Baseline, 4, 8, 16, and 24 weeks)
- Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4, 8, 16, and 24 Weeks(4, 8, 16, and 24 weeks)
- Change From Baseline to 24 Week Endpoint of the Sexual Self-Confidence, Spontaneity, and Time Concerns Domains (23-items) of the Psychological and Interpersonal Relationships Scale (PAIRS)(Baseline, 24 weeks)
- Change From Baseline to 4, 8, 16, and 24 Weeks of the Sexual Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire(Baseline, 4, 8, 16, and 24 weeks)
- Change From Baseline to 4, 8, 16, and 24 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire(Baseline, 4, 8, 16, and 24 weeks)
- Change From Baseline to 4, 8, 16, and 24 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire(Baseline, 4, 8, 16, and 24 weeks)
- Change From Baseline to 4, 8, 16, and 24 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire(Baseline, 4, 8, 16, and 24 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Effect of Tadalafil on Erectile Dysfunction Treatment and QOL Improvement Effect (by SF-12) in Andropause Patients With Erectile DysfunctionAndropauseErectile DysfunctionNCT02943356The Catholic University of Korea40
招募中
3 期
Efficacy of Tadalafil on improvement of erectile dysfunctioErectile dysfunction.Male erectile dysfunctionIRCT20170807035551N2rology Research Center of Tehran University of Medical Sciences60
尚未招募
不适用
Effect of Tadalfil on Erectile Dysfunction among North Indian Males with Diabetes Mellitus.CTRI/2021/10/037629GSVM Medical College
进行中（未招募）
1 期
Impact of Tadalafil (LY450190) Once a Day or Tadalafil On Demand Compared to Sildenafil Citrate On Demand on Treatment Discontinuation in Patients with Erectile Dysfunction who are Naïve to PDE5 InhibitorsMedDRA version: 12.1Level: LLTClassification code 10061461Term: Erectile dysfunctionErectile DysfunctionEUCTR2009-011318-22-FREli Lilly and Company Limited
进行中（未招募）
不适用
Impact of Tadalafil (LY450190) Once a Day or Tadalafil On Demand Compared to Sildenafil Citrate On Demand on Treatment Discontinuation in Patients with Erectile Dysfunction who are Naïve to PDE5 Inhibitors - LVIJMedDRA version: 14.0Level: PTClassification code 10061461Term: Erectile dysfunctionSystem Organ Class: 10038604 - Reproductive system and breast disordersErectile DysfunctionEUCTR2009-011318-22-DEEli Lilly and Company Limited700