NCT02737592已完成不适用
A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects
Church & Dwight Company, Inc.2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2016年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale
研究概览
简要总结
To evaluate the safety of a personal lubricant when used at least four times weekly for two weeks (including at least twice weekly during sexual intercourse for subjects with monogamous male partners), in a population consisting of healthy females.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •no participation in a similar study 2-weeks prior
- •may be post-menopausal or have had a hysterectomy
- •if sexually active, and of child bearing potential, subjects is using adequate non-barrier method of birth control
- •free from any vaginal disorders
- •sexually active and in a monogamous, heterosexual relationship, and whose male partner is willing and able to give informed consent and agrees to engage in sexual intercourse at least twice each week during the two-week study or is not sexually active
- •personal lubricant user and agrees to replace her usual personal lubricant with the investigational product
- •can start regardless of where they are in their cycles
- •agrees to use the provided investigational product at least four time weekly over the two week study period
- •exhibits no clinically significant evidence of vulvar or vaginal irritation, as determined by a study doctor, and no reports of sensory irritation at the baseline exam
- •willing to refrain from introducing any new vaginal products, or using vaginal medications or local contraceptives during study
- •agrees to refrain from douching or using any medications, powder, lotions or personal care products in the vulvar or perianal area
- •willing to use a urine pregnancy test provided to them at baseline and on third visit
- •standard medical history form on file
- •signed informed consent
- •completed HIPAA
- •dependable and able to follow directions as outlined
- •receives a score of 0 or 0.5 for erythema and edema; and 0 for sensorial irritation (burning, stinging, itching and dryness) during the first examination.
排除标准
- •pregnant, nursing or planning a pregnancy
- •currently using or has used within two weeks prior to the study initiation, any systemic or topical corticosteroids, vasoconstrictors, antibiotics, anti-inflammatories or antihistamines
- •known allergies to vaginal or any cosmetic products
- •reports history of recurrent bladder, vaginal infections or incontinence
- •exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days prior to study initiation
- •uses a vaginal ring, diaphram or cervical/vault caps, condoms, or condoms with spermicide as a means of contraception
- •participated in a study involving the vaginal area or in an investigational systemic drug study within two weeks of study initiation
- •receives a score higher than 0/5 for erythema, edema or >0 for burning, stinging, or itching, during first examination or shows any other sign of mucosal irregularities
结局指标
主要结局
Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale
时间窗: 2 weeks
Number of subjects with observed local edema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no edema, 0.5 = slight edema, 1 = mild edema, 2 = moderate edema 3 = severe edema
Number of Subjects With Observed Local Erythema Based on 5 Point Scale
时间窗: 2 weeks
Number of subjects with observed local erythema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no irritation, 0.5 = slight, irregular erythema, 1 = mild erythema, 2 = moderate erythema 3 = severe erythema
次要结局
未报告次要终点
研究者
研究点 (2)
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