A Randomized, Placebo Control, Double-blinded, Double-dummy, Phase 2/3 Combination Study to Evaluate the Safety and Efficacy of TD0025 (Rocket1h) Compared With Sildenafil Citrate for Treatment of Erectile Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), question # 3 and #4
研究概览
简要总结
The purpose of this study is to identify the optimal dose(s) of TD0025 for treatment of erectile dysfunction (phase II) and to investigate if treatment of erectile dysfunction with the optimal dose of TD0025 taken as needed over one month is non-inferior than Sildenafil Citrate taken as needed over one month (phase III)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of Erectile Dysfunction (ED) of at least 1 month 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.
- •Sign the informed consent form
排除标准
- •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 doxazocin, 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
Part A- Arm 1
Investigational dose = 0.25 time of the expected dose. The drug should not be taken more than one time a day or 3 times a week Drug: TD0025 Administered orally once a day, 5 hours before sexual activity, for 1 month.
干预措施: TD0025 (Drug)
Part A- Arm 2
Investigational dose = 0.5 time of the expected dose. The drug should not be taken more than one time a day or 3 times a week Drug: TD0025 Administered orally once a day, 5 hours before sexual activity, for 1 month.
干预措施: TD0025 (Drug)
Part A- Arm 3
Investigational dose = 1 time of the expected dose. The drug should not be taken more than one time a day or 3 times a week Drug: TD0025 Administered orally once a day, 5 hours before sexual activity, for 1 month.
干预措施: TD0025 (Drug)
Part A- Arm 4
Investigational dose = 1.25 time of the expected dose. The drug should not be taken more than one time a day or 3 times a week Drug: TD0025 Administered orally once a day, 5 hours before sexual activity, for 1 month.
干预措施: TD0025 (Drug)
Part B- Arm 1
Investigational dose = optimal dose in Part A. The drug should not be taken more than one time a day or 3 times a week.
Drug: TD0025 Administered orally once a day, 5 hours before sexual activity, for 1 month
干预措施: TD0025 (Drug)
Part B- Arm 2
Sildenafil Citrate 50 mg on demand The drug should not be taken more than one time a day or 3 times a week. Administered orally once a day, 1 hour before sexual activity, for 1 month
干预措施: Sildenafil Citrate 50mg (Drug)
结局指标
主要结局
PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), question # 3 and #4
时间窗: Baseline, 4 weeks
PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain
时间窗: Baseline, 4 weeks
次要结局
- PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Erectile Function (EF) Domain(Baseline, 4 weeks)
- PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Orgasmic Function Domain(Baseline, 4 weeks)
- PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Overall Satisfaction Domain(Baseline, 4 weeks)
- PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Sexual Desire Domain(Baseline, 4 weeks)
- PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain(Baseline, 4 weeks)
- PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Orgasmic Function Domain(Baseline, 4 weeks)
- PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Sexual Desire Domain(Baseline, 4 weeks)
- PART B- PHASE III: Time to Discontinuation of Randomized Treatment(Baseline up to 30 days)
- PART A- PHASE II: The percentage of patients with abnormal Testosterone, FSH, LH and Androgen Serum Levels at Baseline and after 4 weeks of treatment(Baseline, 4 weeks)
- PART A- PHASE II: The percentage of patients with abnormal hematology and biochemistry laboratory values at baseline and after 4 weeks of treatment(Baseline, 4 weeks)
- PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain(Baseline, 4 weeks)
- PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Overall Satisfaction Domain(Baseline, 4 weeks)
- PART B- PHASE III: Change From Baseline to 4 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire(Baseline, 4 weeks)
- PART B- PHASE III: Change From Baseline to 4 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire(Baseline, 4 weeks)
- PART B- PHASE III: The percentage of patients with abnormal Testosterone, FSH, LH and Androgen Serum Levels at Baseline and after 4 weeks of treatment(Baseline, 4 weeks)
- PART B- PHASE III: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4 Weeks(4 weeks)
- PART B- PHASE III: Change From Baseline to 4 Weeks of the Sexual Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire(Baseline, 4 weeks)
- PART B- PHASE III: Change From Baseline to 4 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire(Baseline, 4 weeks)
- PART B- PHASE III: The percentage of patients with abnormal hematology and biochemistry laboratory values at baseline and after 4 weeks of treatment(Baseline, 4 weeks)