NCT07802483尚未招募不适用
Safety Assessment of pH-D New Instant Rinse for One Time Use
pH-D Feminine Health LLC0 个研究点目标入组 90 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Written questionnaire to assess outcomes of the single use vaginal odor rinse
研究概览
简要总结
Demonstrate the safety characteristics of new formulations of pH-D foam wash and instant rinse
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant females, 18 years and older
- •Complaint of abnormal vaginal odor with or without complaints of discharge
- •Odor rated ≥4 on a 0-10 numerical rating scale (NRS) (0 = NO odor, 10 = strong unpleasant odor)
- •Willing/able to comply with study requirements
- •Has provided informed consent
- •Subject has regular cycle length of 24-35 days
排除标准
- •Patients genital lesions or ulcers consistent with human papillomavirus (HPV), Herpes simplex, syphilis, chancroid, etc.). Patients with a history of genital herpes or condylomata who have been asymptomatic for at least 3 months may be considered for eligibility.
- •Patients who will undergo evaluation or treatment during the study for abnormal cytology and/or findings from high risk HPV testing and/or Pap test finding.
- •Subjects with lower genital tract infections (e.g. symptomatic VVC, trichomoniasis, HSV) diagnosed in the past 30 days
- •Subjects with other Vaginal or Vulvar condition that would interfere with clinical interpretation of data (e.g. vaginal or vulvar dysplasia, lichen sclerosis)
- •Subject has received antibiotic or antifungal treatment in the past 14 days
- •Subject is currently menstruating or is expected to menstruate in the next 7 days. Patients will be enrolled but start suppositories after menses has concluded
- •Investigator considers a medical or other identifiable reason for subject's vaginal odor
研究组 & 干预措施
subjects using instant rinse (lactic acid)
Active Comparator
干预措施: Lactic Acid instant odor rinse (Other)
subjects using boric acid
Active Comparator
干预措施: Boric Acid instant odor rinse (Other)
subjects using placebo
Active Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Written questionnaire to assess outcomes of the single use vaginal odor rinse
时间窗: 72 hours
次要结局
未报告次要终点
研究者
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