PLEASURE (Pleasing Lovers, Efficacy, Arousal, Satisfaction, and Uptake Research on Eroxon): A Pilot Randomized Trial of Eroxon® Gel as an Adjunct to Tadalafil in Young Men With Diabetes-Associated Erectile Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Erectile Functioning
研究概览
简要总结
The purpose of this research study is to look at whether Eroxon® gel when used together with tadalafil, may help improve erectile function in men ages 18 to 40 who have type 2 diabetes.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- Male sex at birth
- Age 18-40 years
- Diagnosis of type 2 diabetes mellitus
- Diagnosis of erectile dysfunction
- Currently prescribed tadalafil
- Have a sexual partner willing to complete a survey
- Ability to provide informed consent
排除标准
- Type 1 diabetes mellitus
- Severe psychiatric illness that would impair participation
- Use of nitrates or contraindications to sexual activity
- Known allergy to Eroxon® gel components
- Participation in another interventional sexual health study
研究组 & 干预措施
Standard of Care (Tadalafil) + Eroxon® Gel Group
Participants assigned to this arm will continue to use tadalafil as prescribed per standard of care treatment and will also be instructed to use Eroxon® gel prior to each sexual encounter throughout the 12-week study period.
干预措施: tadalafil (Drug)
Tadalafil (Control) Group
Participants assigned to this arm will continue their standard-of-care treatment with tadalafil as prescribed. No study-specific changes will be made to their routine clinical management.
干预措施: tadalafil (Drug)
Standard of Care (Tadalafil) + Eroxon® Gel Group
Participants assigned to this arm will continue to use tadalafil as prescribed per standard of care treatment and will also be instructed to use Eroxon® gel prior to each sexual encounter throughout the 12-week study period.
干预措施: Eroxon® (Device)
结局指标
主要结局
Change in Erectile Functioning
时间窗: Baseline to Week 12
Erectile function assessed using the International Index of Erectile Function-5 (IIEF-5), a validated 5-item patient-reported questionnaire. Total scores range from 5 to 25, with higher scores indicating better erectile function.
次要结局
- Change in Patient Adherence(Baseline to Week 12)
- Change in Partner Acceptability(Baseline to Week 12)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07636161
- 其他研究编号
- 20260268
日期
- 首次提交
- (3个月前)
- 首次发布
- (3个月前)
- 主要完成日期
- (11个月后)
- 研究完成日期
- (11个月后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 是
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否