National, Multicenter, Randomized, Double-blind, Double-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Tanzânia Association in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 295
- 试验地点
- 1
- 主要终点
- Change from baseline in erectile function questionnaire.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Tanzânia association in adults with erectile dysfunction associated with Benign Prostatic Hyperplasia.
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 aged 18 years or more;
- •Sexually active participants with a defined partner who have averaged 1 attempt at sexual intercourse per week in the past month;
- •Diagnosis of Benign Prostatic Hyperplasia;
- •Diagnosis of erectile dysfunction;
- •Patients with score between 6 and 25 points in the erectile function questionnaire;
- •IPSS (International Prostate Symptom Score) greater or equal to 8 points;
排除标准
- •Known hypersensitivity to the formula components used during the clinical trial;
- •History of alcohol and/or substance abuse within 2 years;
- •Diagnosis of other diseases or conditions in the urinary tract, including but not limited to: cancer, neurogenic bladder; urinary incontinence, recurrent infection, urethral stricture, bacterial prostatitis;
- •Clinical evidence of prostate cancer;
- •Hypogonadism or absent sexual desire;
- •Severe psychiatric or psychosocial disorders;
- •Primary erectile dysfunction;
- •Polyneuropathy, neurodegenerative diseases, trauma or spinal cord injuries, central nervous system tumors or other conditions that may affect erections;
- •Anatomical penile deformation that can significantly impair erection, including but not limited to: angulation, cavernous fibrosis, Peyronie's disease.
研究组 & 干预措施
TANZÂNIA
The study is double-dummy. The patient must take 2 pills, as follow:
1 capsule Tanzânia association, oral, once a day, and
1 tablet tamsulosin placebo, oral, once a day.
干预措施: Tanzânia association (Drug)
TANZÂNIA
The study is double-dummy. The patient must take 2 pills, as follow:
1 capsule Tanzânia association, oral, once a day, and
1 tablet tamsulosin placebo, oral, once a day.
干预措施: Omnic Ocas placebo (Other)
Omnic Ocas
The study is double-dummy. The patient must take 2 pills, as follow:
1 tablet Omnic Ocas, oral, once a day, and
1 capsule Tanzânia association placebo, oral, once a day.
干预措施: Omnic Ocas (Drug)
Omnic Ocas
The study is double-dummy. The patient must take 2 pills, as follow:
1 tablet Omnic Ocas, oral, once a day, and
1 capsule Tanzânia association placebo, oral, once a day.
干预措施: Tanzânia association placebo (Other)
结局指标
主要结局
Change from baseline in erectile function questionnaire.
时间窗: 8 weeks
The erectile function questionnaire score ranges from 1 to 30 points. The lower the score, the higher the degree of erectile dysfunction.
次要结局
- Incidence and severity of adverse events recorded during the study.(10 weeks)