A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect on Unassisted Erectile Function of the Early Use of Tadalafil 5 mg Once a Day and Tadalafil 20 mg On Demand Treatment for 9 Months in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 583
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire
研究概览
简要总结
The study will include patients with localized prostate cancer who experience erectile dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for 9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for recovery of unassisted erectile function (without medication). An open-label extension for three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day. Further objectives are to evaluate the treatment satisfaction of the respective therapies.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •scheduled to undergo Bilateral nerve-sparing radical prostatectomy (BNSRP) for organ-confined, non-metastatic prostate cancer
- •have a normal preoperative erectile function score of more or equal to 22 at screening(as evaluated by International Index of Erectile Function - Erectile Function domain (IIEF-EF))
- •develop Erectile Dysfunction (ED) (defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) after surgery
- •have an interest in resuming sexual activity as soon as possible after surgery and anticipate having the same adult female sexual partner during the study
- •agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study
- •does not require the initiation of adjuvant therapy for prostate cancer
排除标准
- •history of ED
- •have received previous or current treatment with tadalafil or any other Phosphodiesterase Type 5 (PDE5) inhibitor
- •have undergone, or plan to undergo, radiation or hormonal therapy for prostate cancer
- •have a history of prostatic surgery or prostatic physical treatments
- •have a history of diabetes mellitus
- •have a history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
- •have clinically significant renal insufficiency as determined by the investigator
研究组 & 干预措施
Tadalafil daily [5 milligrams (mg)]
After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.
干预措施: Tadalafil (Drug)
Tadalafil on demand (20 mg)
After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.
干预措施: Tadalafil (Drug)
Placebo
After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire
时间窗: Month 10.5
Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.
次要结局
- Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain(Month 9 and Month 13.5)
- Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score(Randomization (Baseline), Months 9 and 10.5 and 13.5)
- Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)(Randomization (Baseline), Months 9 and 10.5 and 13.5)
- Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score(Months 9 and 13.5)
- Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score(Randomization (Baseline), Months 9 and 13.5)
- Global Assessment Questions (GAQ) Question 1 at Month 9(Month 9)
- Global Assessment Question (GAQ) Question 1 at Month 13.5(Month 13.5)
- Global Assessment Question (GAQ) Question 2 at Month 9(Month 9)
- Global Assessment Question (GAQ) Question 2 at Month 13.5(Month 13.5)
- Residual Erectile Function (REF) at Baseline(Baseline)
- Residual Erectile Function (REF) at Month 2(Month 2)
- Residual Erectile Function (REF) at Month 5(Month 5)
- Residual Erectile Function (REF) at Month 9(Month 9)
- Residual Erectile Function (REF) at Month 10.5(Month 10.5)
- Residual Erectile Function (REF) at Month 13.5(Month 13.5)
- Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)(Randomization (Baseline), Months 9 and 10.5 and 13.5)
- Change From Baseline in 'Yes' Answers to Morning Erections(Randomization (Baseline), Month 10.5)
- Standardized Morning Erections Question (SMEQ) Score at Month 2(Month 2)
- Standardized Morning Erections Question (SMEQ) Score at Month 9(Month 9)
- Standardized Morning Erections Question (SMEQ) Score at Month 13.5(Month 13.5)
- Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score(Randomization (Baseline), Months 9 and 13.5)
- Change in Penile Length and Girth(Randomization (Baseline), Month 9)