NCT07391241招募中2 期
A Randomised, Double-blind, Placebo-controlled, 4-way Cross-over Trial Studying the Efficacy and Safety of Single Dose Administration of Pudafensine in Vulvodynia (Provoked Vestibulodynia).
Initiator Pharma1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年12月17日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to evaluate the effect of pudafensine on pain in the vaginal vestibule (vestibular pain threshold) using the Vestibular Pain Threshold Test
研究概览
简要总结
The study (IP2015CS05) is a randomised, double-blind, placebo-controlled, 4-way cross-over trial studying the efficacy and safety of single dose administration of pudafensine in vulvodynia (provoked vestibulodynia) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant with vulvodynia (provoked vestibulodynia).
排除标准
- •Women with vulvar pain caused by a specific disorder:
- •Infectious (e.g. recurrent candidiasis, herpes).
- •Inflammatory (e.g. lichen sclerosus, lichen planus, immunobullous disorders).
- •Neoplastic (e.g. Paget disease, squamous cell carcinoma).
- •Neurologic (e.g. postherpetic neuralgia, nerve compression or injury, neuroma).
- •Trauma (e.g. female genital cutting, obstetrical).
- •Iatrogenic (e.g. postoperative, chemotherapy, radiation).
- •Hormonal deficiencies (e.g. genitourinary syndrome of menopause (vulvovaginal atrophy), lactational amenorrhea).
- •History or current diagnosis of significant pelvic floor dysfunction.
- •Co-morbid pelvic pain conditions including pain due to pelvic fractures, pelvic girdle pain or post-partum pelvic pain (to avoid confounding pain outcomes).
- •History or current diagnosis of pelvic inflammatory disease.
- •History or current diagnosis of endometriosis.
- •History or current diagnosis of interstitial cystitis.
研究组 & 干预措施
Dose_1
Experimental
Pudafensine
干预措施: Pudafensine (Drug)
Dose_2
Experimental
Pudafensine
干预措施: Pudafensine (Drug)
Dose_3
Experimental
Pudafensine
干预措施: Pudafensine (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Pudafensine (Drug)
结局指标
主要结局
The primary objective of this study is to evaluate the effect of pudafensine on pain in the vaginal vestibule (vestibular pain threshold) using the Vestibular Pain Threshold Test
时间窗: Through study completion, an average of 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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