Satisfaction of Patients With Erectile Dysfunction With the Use of Sildenafil Oral Suspension Compared to Orodispersible Tablets
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Endpoint 1
研究概览
简要总结
The goal of this observational retrospective study is to to evaluate treatment satisfaction with sildenafil oral suspension in patients with mild-to-moderate ED who were previously taking orodispersible sildenafil.
The secondary objective is to evaluate the efficacy and side effects of therapy with sildenafil oral suspension compared to orodispersible sildenafil.
Patients who took sildenafil orodispersible 50 mg for 3 months and subsequently took sildenafil oral suspension for another 3 months will be enrolled.
详细描述
Erectile dysfunction (ED) is a very common condition affecting approximately 50% of men over 40. Numerous studies have shown that ED has a significant negative impact on a couple's quality of life and can lead to depressive symptoms and a loss of self-esteem. The first-line treatment for ED is phosphodiesterase type 5 inhibitors (PDE5 inhibitors). In Italy, four drugs are approved for the treatment of ED: sildenafil, tadalafil, vardenafil, and avanafil, each available in different formulations and dosages. Despite the wide variety of options, the dropout rate from ED therapy is very high. This is explained by the need for personalized therapy for each ED patient and by the demands of men not met by current medications on the market. Specifically, ED patients require treatment that is spontaneous, effective, and easily adjustable. These characteristics are often not met by the formulations and dosages of PDE5 inhibitors currently available. Tablet formulations, for example, are often associated with illnesses and are not always accepted by patients, especially those with swallowing difficulties. Furthermore, they cannot be precisely portioned in the event of dose de-escalation. Orodispersible films have poor palatability and are difficult to portion into equal portions. A new formulation of sildenafil in oral suspension was recently introduced to the Italian market. The oral suspension, consisting of sprays of 12.5 mg of sildenafil at a time, is intended to meet patient needs in terms of rapid onset, efficacy, and therapeutic modulation.
The primary objective is to evaluate treatment satisfaction with sildenafil oral suspension in patients with mild-to-moderate ED who were previously taking orodispersible sildenafil.
The secondary objective is to evaluate the efficacy and side effects of therapy with sildenafil oral suspension compared to orodispersible sildenafil.
Primary endpoint: Change in the total satisfaction domain score after 3 months of treatment with sildenafil oral suspension 50 mg as needed compared to previous treatment with sildenafil orodispersible 50 mg as needed.
Secondary endpoints will be:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18-75
- •Sexually active (at least 2 sexual encounters per week)
- •IIEF-EF between 11 and 25 at baseline
排除标准
- •hypogonadism (total testosterone < 3.5 ng/mL)
- •previous pelvic surgery
- •ED on a neurogenic basis
- •concomitant use of other ED therapies
- •conical therapy with nitrates or other contraindicated drugs in combination with sildenafil
- •hypersensitivity to the active ingredient
- •patients for whom sexual activity is not recommended (e.g. patients with serious cardiovascular disorders, such as unstable angina or severe heart failure).
- •patients who have lost vision in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION), whether or not this event was related to previous use of a phosphodiesterase type 5 (PDE5) inhibitor
- •patients with severe hepatic impairment, hypotension (blood pressure <90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal diseases, such as retinitis pigmentosa
- •patients treated with guanylate cyclase stimulants, such as riociguat.
研究组 & 干预措施
group 1
group 1
干预措施: Sildenafil Oral Suspension Compared to Orodispersible Tablets (Drug)
结局指标
主要结局
Endpoint 1
时间窗: from enrollment to the end of treatment
Change in the total satisfaction domain score after 3 months of treatment with sildenafil oral suspension 50 mg as needed compared to previous treatment with sildenafil orodispersible 50 mg as needed
Satisfaction measurement
时间窗: from enrollment to the end of treatment
Change in the total satisfaction domain score after 3 months of treatment with sildenafil oral suspension 50 mg as needed compared to previous treatment with sildenafil orodispersible 50 mg as needed
次要结局
未报告次要终点
研究者
Luca Boeri
Principal Investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico