PACTR201303000491420尚未招募未知
Contraceptive and safety studies of UniPron
Institute of Primate Research0 个研究点目标入组 0 人开始时间: 2013年1月30日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Year(s) 至 45 Year(s)（—）
- 性别
- Female
入选标准
- •HIV negative
- •Willing and able to maintain sexual abstinence during study period
- •Not pregnant (based on negative urine pregnancy results
- •Negative screen for STIs
- •Adequate general and gynaecologic heath
- •Willing to abstain from using any vaginal products (other than the study product or placebo
- •Normal pap smear at screening or documentation of such within six months
- •Agree to pelvic exam, colposcopy and biopsy if indicated
- •Willing to complete study
- •Agree to apply assigned study gel as required by protocol
- •Willing to participate and sign an informed
- •consent form
- •Having normal menstrual cycle defined as having a minimum of 21 days and a maximum 36 days between menses
- •Availability to return for all study visits, barring unforeseen circumstances
- •Anticipate 10 men for invitro semen analysis and 60 women for safety studies
排除标准
- •Currently pregnant of breastfeeding
- •Clinically detectable genital abnormality on the vulva, vaginal walls or cervix
- •Laboratory confirmed STIs, chlamydia, trichomonas, syphilis or vaginal candidiasis or clinically diagnosed genitourinary disease (GUD) or active HSV-2 lesion
- •Symptomatic bacterial vaginosis at screening and unwilling to undergo treatment
- •Using another intravaginal preparation
- •History of genital ulcer disease
- •History of severe allegic reactions
- •HIV positive
- •Not willing to adhere to the study protocol
- •Have received antibiotics 14 days prior to enrollment
- •Have used a spermicide or spermicidal lubricated condom within 7 days prior to enrollment
- •Grade 3 or higher liver, renal or hematology abnormality as defined by the table for grading severity of Adult Adverse Events at screening
- •Grade 3 or higher exam pelvic finding
- •Any condition that, in the opinion of the investigator would interfere with the study
- •Have douched or used vaginal products, including lubricants, feminine hygiene products, vaginal drying agents and sex toys 48 hours prior to study entry
- •Received treatment for candida, bacterial vaginosis or urinary tract infections within one month prior to the study entry
- •Previous gynecologic surgery or have received treatment for syphilis, genital herpes, chlamydia, gonorrhea, trichomonas or genital warts within 6 months prior to study entry
- •History of intermenstrual bleeding within 3 months prior to study entry
- •Currently using hormonal contraception or have used hormonal contraceptive within two months of study entry
- •Currently participating in a research study of other vaginal products
- •Pregnant, less than 6 months postpartum, or breastfeeding
- •Menstruating at screening or enrollment visits
研究者
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