Efficacy of Daily 5-mg Tadalafil as Adjunctive Therapy Versus Monotherapy in Men With On-Demand PDE5 Inhibitor-Resistant Erectile Dysfunction: A Prospective Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- change in International Index of Erectile Function-Erectile Function score from baseline to week 12.
研究概览
简要总结
This randomized trial will compare daily tadalafil 5 mg as adjunct therapy versus monotherapy in men with on-demand PDE5 inhibitor-resistant erectile dysfunction. The study will evaluate changes in erectile function, treatment satisfaction, partner satisfaction, and safety over 12 weeks.
详细描述
Erectile dysfunction (ED) is a common male sexual disorder, and oral phosphodiesterase type 5 (PDE5) inhibitors are commonly used as first-line treatment. However, some men continue to report inadequate erectile function despite appropriate on-demand PDE5 inhibitor use, adequate sexual stimulation, and dose optimization.
This prospective, randomized, parallel-group trial will evaluate whether adding an on-demand PDE5 inhibitor to daily tadalafil 5 mg provides greater improvement in erectile function than daily tadalafil 5 mg alone in men with on-demand PDE5 inhibitor-resistant ED.
Eligible participants will be men aged 21 to 70 years with ED for at least 6 months who have used an on-demand PDE5 inhibitor for at least 3 months without satisfactory improvement. Inadequate response will be confirmed by an International Index of Erectile Function-Erectile Function domain (IIEF-EF) score below 26, self-reported inability to achieve or maintain an erection sufficient for satisfactory intercourse in at least 50% of attempts, and documented appropriate medication use with adequate sexual stimulation.
Participants will be randomly assigned in a 1:1 ratio to one of two treatment groups for 12 weeks. The adjunct-therapy group will receive tadalafil 5 mg once daily together with the participant's established on-demand PDE5 inhibitor at the effective dose, taken before sexual activity according to the approved prescribing instructions and study restrictions. The monotherapy group will receive tadalafil 5 mg once daily without an additional on-demand PDE5 inhibitor.
The primary outcome will be the change in IIEF-EF score from baseline to Week 12. Secondary outcomes will include the proportion of treatment responders, Sexual Encounter Profile Question 2 success rate, Sexual Encounter Profile Question 3 success rate, Erection Hardness Score, erectile dysfunction treatment satisfaction, partner satisfaction where applicable, psychological well-being, treatment adherence, and safety.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 70 years.
- •Diagnosis: Erectile dysfunction for at least 6 months.
- •PDE5 inhibitor resistance: History of on-demand PDE5 inhibitor use for at least 3 months with inadequate response, defined as:
- •International Index of Erectile Function-Erectile Function score less than 26 despite optimal dosing.
- •Self-reported inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse in at least 50% of attempts.
- •Confirmed proper medication use with at least 4 to 8 attempts with adequate sexual stimulation.
- •Stable relationship: Sexually active with a female partner for at least 6 months.
- •Informed consent: Willing and able to provide written informed consent.
排除标准
- •Current use of nitrates.
- •Unstable cardiovascular disease, including recent myocardial infarction within 6 months, unstable angina, or severe heart failure.
- •Uncontrolled hypertension greater than 180 over 110 mmHg or severe hypotension less than 90 over 50 mmHg.
- •Severe hepatic impairment, Child-Pugh class C, or renal impairment with estimated glomerular filtration rate less than 30 mL per minute per 1.73 m².
- •Untreated hypogonadism, total testosterone less than 250 ng/dL.
- •Severe penile anatomic deformity or prior penile prosthesis.
- •History of priapism.
- •Severe untreated depression.
- •Pelvic surgery or radiation within 6 months.
研究组 & 干预措施
Adjunct Therapy
Participants will receive tadalafil 5 mg orally once daily for 12 weeks plus their current effective on-demand PDE5 inhibitor, taken 1-2 hours before sexual activity, with a maximum of once daily.
干预措施: Tadalafil; Current on-demand PDE5 inhibitor (Drug)
Monotherapy
Participants will receive tadalafil 5 mg orally once daily for 12 weeks.
干预措施: Tadalafil 5 mg (Drug)
Adjunct Therapy
Participants will receive tadalafil 5 mg orally once daily for 12 weeks plus their current effective on-demand PDE5 inhibitor, taken 1-2 hours before sexual activity, with a maximum of once daily.
干预措施: Tadalafil 5 mg (Drug)
结局指标
主要结局
change in International Index of Erectile Function-Erectile Function score from baseline to week 12.
时间窗: 12 weeks
The International Index of Erectile Function-Erectile Function domain score ranges from 1 to 30, with higher scores indicating better erectile function.
Adverse effect / side effect
时间窗: 12 weeks
a harmful effect that is attributable to the intervention.
次要结局
- Responder rate(12 weeks)
- Percentage of Sexual Attempts With Successful Intercourse - Sexual Encounter Profile Question 3(12 weeks)
- Percentage of Sexual Attempts With Successful Vaginal Penetration - Sexual Encounter Profile Question 2(12 weeks)
- Erection Hardness Score(12 weeks)
- Erectile Dysfunction Inventory of Treatment Satisfaction.(12 weeks)
- the 7-item Generalized Anxiety Disorder scale(12 weeks)
- partner-reported satisfaction(12 weeks)
- Treatment adherence(12 weeks)
研究者
Abul-fotouh Ahmed
Principal Investigator
Al-Azhar University