跳至主要内容
临床试验/NCT02737852
NCT02737852已完成不适用

A Single-Center, Clinical Study to Evaluate the Safety of a New 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 32 人开始时间: 2016年3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
已完成
发起方
入组人数
32
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 new 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
None

盲法说明

The new personal lubricant was used by all participants

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

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 using adequate non-barrier method of birth control
  • free from any vaginal disorders
  • sexually active and 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 times 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

研究组 & 干预措施

Healthy subject

Experimental

Healthy subject exposed to Trojan "Chameleon" Personal Lubricant at least four times weekly for two weeks

干预措施: Trojan "Chameleon" Personal Lubricant (Device)

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 obstetrician/gynecologist 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 the 5 Point Scoring Scale

时间窗: 2 weeks

Number of subjects with observed local erythema by obstetrician/gynecologist 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

发起方
Church & Dwight Company, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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