National, Multicenter, Randomized, Double-blind, Double-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 232
- 主要终点
- Percentage of participants with treatment response after 4 weeks of treatment.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Toronto association in the treatment of both sexual dysfunction: erectile dysfunction and premature ejaculation.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
- •Male participants, with age greater than or equal to 18 years;
- •Heterosexual, sexually active participants in a stable and monogamous relationship for at least 6 months before screening and who plan to maintain this relationship throughout the study period;
- •Participants with erectile dysfunction, in stable and effective treatment with PDE-5 inhibitors;
- •Participants diagnosed with premature ejaculation;
- •Participants with IELT ≤ 2 minutes;
- •Participants with score ≥ 25 points in the erectile function questionnaire;
- •Participants (or partners) who use at least one contraceptive method.
排除标准
- •Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- •Participation in a clinical trial in the year prior to this study;
- •Known hypersensitivity to any of the formula compounds;
- •Participants with cardiovascular disease for whom sexual activity is inadvisable
- •History or current experience of surgical interventions or radiotherapy in the pelvic region, neurological conditions, trauma or infections that are associated with the symptoms premature ejaculation;
- •Diagnosis of other diseases or conditions in the urinary tract;
- •Participants with conditions that may predispose them to priapism;
- •History of severe psychiatric or psychosocial disorders;
- •Participant whose partner has clinically important sexual dysfunctions.
研究组 & 干预措施
TORONTO 20 + 30/60
The study is double-dummy. The patient must take 2 tablets before the sexual intercourse, as follows:
1 tablet of Toronto association, oral;
1 tablet of tadalafil placebo, oral.
干预措施: Toronto association (Drug)
TORONTO 20 + 30/60
The study is double-dummy. The patient must take 2 tablets before the sexual intercourse, as follows:
1 tablet of Toronto association, oral;
1 tablet of tadalafil placebo, oral.
干预措施: Tadalafil placebo (Other)
TADALAFIL
The study is double-dummy. The patient must take 2 tablets before the sexual intercourse, as follows:
1 tablet of tadalafil , oral;
1 tablet of Toronto association placebo, oral.
干预措施: Tadalafil (Drug)
TADALAFIL
The study is double-dummy. The patient must take 2 tablets before the sexual intercourse, as follows:
1 tablet of tadalafil , oral;
1 tablet of Toronto association placebo, oral.
干预措施: Toronto association placebo (Other)
结局指标
主要结局
Percentage of participants with treatment response after 4 weeks of treatment.
时间窗: 4 weeks
The treatment response will be based on the participant's questionnaire answer after the treatment.
Percentage of participants with treatment response after 8 weeks of treatment.
时间窗: 8 weeks
The treatment response will be based on the participant's questionnaire answer after the treatment.
次要结局
- Adverse events(103 days)