NCT01283555已完成不适用
Comparative Safety Study of Pre-Filled Plastic and User-Filled Paper Vaginal Applicators With Candidate Microbicide, Tenofovir
PATH1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of Colposcopic Findings (Baseline and After One Week of Product Use)
研究概览
简要总结
The primary objective of this study is to compare the effect of two vaginal applicators, delivering the candidate microbicide Tenofovir, on symptoms and signs of irritation of the external genitalia, cervix and vagina as seen on colposcopy after seven days of twice daily use.
The secondary objectives are to:
- Evaluate and compare the dosing accuracy and precision of the user-filled applicator and pre-filled applicator with the candidate microbicide, Tenofovir.
- Compare the acceptability of the user-filled applicator with the pre-filled applicator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 50, inclusive
- •Pre-menopausal
- •In good health as reported by individual
- •Have regular menstrual cycles (24 to 35 days)
- •Low risk for sexually transmitted infections (only one sexual partner in the last three months)
- •Not pregnant or at risk of pregnancy (must either have had a tubal ligation, or currently be using a hormonal method of contraception)
- •Negative on a urine pregnancy test
- •Willing to abstain from sexual intercourse and masturbation during two 7-day periods when applicators are being used
- •Willing to abstain from use of vaginal products during course of study (including douching, use of vaginal applicators for medication, lubrication, sex toys, other)
- •Willing to follow procedural requirements of study
- •Willing and able to provide informed consent for study participation
- •Willing to provide investigator with phone number or address where she can be reached during the study
排除标准
- •History of hysterectomy
- •Pregnancy or within two months of last pregnancy outcome (delivery, spontaneous or induced abortion, medical or surgical management of ectopic pregnancy)
- •Post-menopausal
- •Breastfeeding
- •Use of an intra-uterine device (IUD), cervical caps or diaphragm for contraceptive purposes
- •Diagnosis or treatment for a sexually transmitted disease within the past 30 days;
- •More than one sexual partner in the last 3 months
- •Has had surgery on the external genitalia, vagina, or cervix within the past 3 months;
- •Current or past use of any anti-retroviral therapies including but not limited to systemic Tenofovir (Viread®)
- •Current or anticipated use of drugs on a daily basis that may reduce renal function (e.g. acyclovir or ibuprofen) or liver function (e.g. Tylenol)
- •HIV positive at time of screening
- •Hepatitis B surface antigen (HBsAg) positive at time of screening
- •Positive test results for Neisseria gonorrhea, Chlamydia trachomatis, or Trichomonas vaginalis at time of screening.
- •At baseline colposcopic exam (Visit 2), findings involving disruption of epithelium with disruption of blood vessels or deep disruption of epithelium alone. Any area of epithelium with bleeding will be considered deeply disrupted.
- •Any abnormal finding on colposcopic exams which in the opinion of the investigator, precludes participation in the study
- •At baseline exams, clinical symptoms or signs of vaginitis or vulvitis confirmed by a wet mount exam of the discharge. Note: If vaginitis or vulvitis is present at either baseline exam (visits 2 or 10), volunteer will be treated and rescheduled for new baseline exam one week after application of last treatment dose. If signs or symptoms are still present at the rescheduled baseline exam for Visit 2, the volunteer will not be enrolled into study. If signs or symptoms are still present at the rescheduled baseline exam for Visit 10, the volunteer will be discontinued from the study.
- •Serum chemistry (glucose, creatinine, bilirubin, AST [aspartate aminotransferase] and ALT [alanine transaminase]) not within normal expected levels according to the specifications of the local laboratory.
- •Hemoglobin, hematocrit and total white blood cell not within 15 % of lower and upper limit normal levels according to the specifications of the local laboratory.
- •Participation in any other research study in the 30 days prior to screening and/or plans to participate in any other research study during the entire study duration.
研究组 & 干预措施
User-Filled Applicator
Experimental
干预措施: Tenofovir (Drug)
Prefilled applicator
Other
干预措施: Tenofovir (Drug)
结局指标
主要结局
Number of Colposcopic Findings (Baseline and After One Week of Product Use)
时间窗: 7 days
Comparison of colposcopic findings between baseline visits and after one week of twice-daily application of Tenofovir 1% gel with either a user-filled or prefilled applicator
次要结局
- Dosing Precision, 10% (Expressed Volume)(3 dose delivery measurements during 1 week of product use)
- Number of Participants Reporting Applicator Easy to Fill(Final study visit (after completing both study arms))
- Number of Respondents Reporting Confidence With Filling the User-filled Applicator(Final study visit (after completing both study arms))
- Number of Participants Reporting That Applicator Was Comfortable to Use(Final study visit (after completing both study arms))
- Filled Volume(3 dose delivery measurements during 1 week of product use)
- Filling Accuracy (% of Target Dose)(3 dose delivery measurements during 1 week of product use)
- Reasons Given by Participants for Knowing When the Applicator Was Filled Correctly(Final study visit (after completing both study arms))
- Number of Participants Reporting Applicator Easy to Insert(Final study visit (after completing both study arms))
- Number of Participants Reporting That the Gel Was Easy to Dispense(Final study visit (after completing both study arms))
- Number of Participants Reporting Applicator Preference (User-filled or Prefilled) Across a Variety of Factors(Final study visit (after completing both study arms))
- Number of Participants Reporting Suggestions Regarding Ease of Use or Comfort(Final study visit (after completing both study arms))
- Number of Participants Reporting That They Would Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention(Final study visit (after completing both study arms))
- Number of Participants Reporting That the Cost of the Applicator Would Influence Their Choice of Applicator(Final study visit (after completing both study arms))
- Number of Participants Reporting That They Would Not Want to Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention(Final study visit (after completing both study arms))
- Number of Participants Reporting That Both Applicators Were Acceptable(Final study visit (after completing both study arms))
- Filling Precision (5% Range)(3 dose delivery measurements during 1 week of product use)
- Number of Participants Reporting That the Instructions for Use Were Helpful(Final study visit (after completing both study arms))
- Number of Participants Reporting That They Would Recommend the User-filled Applicator for HIV Prevention(Final study visit (after completing both study arms))
- Filling Precision (10% Range)(3 dose delivery measurements during 1 week of product use)
- Dosing Volume (Expressed Volume)(3 dose delivery measurements during 1 week of product use)
- Dosing Precision, 5% (Expressed Volume)(3 dose delivery measurements during 1 week of product use)
- Dosing Accuracy (% of Target Dose Delivered)(3 dose delivery measurements during 1 week of product use)
研究者
研究点 (1)
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