A phase I/II study on the safety, tolerance and acceptability of a vaginal gel containing sodium lauryl sulphate (invisible condom) in healthy subjects

aval University (Canada)0 个研究点目标入组 452 人开始时间: 2005年11月18日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Signed an informed consent
•2. Healthy female subjects aged between 18 to 49 years
•3. Normal physical and gynaecological examinations
•4. Normal colposcopic examination
•5. Have regular menstrual cycle with 21 - 40 days between menses
•6. Human immunodeficiency virus (HIV)-negative subjects and at low risk of acquiring HIV
•7. At low risk of getting sexually transmitted diseases (STDs), i.e., sexually abstinent or having history of protected sexual intercourse or having a stable sexual partner
•8 Agreeing to abstain from sexual intercourse from screening to the end of the study (for sexually abstinent subjects)
•9. Agreeing to have a minimum of four sexual intercourses for each period of 2 weeks of gel application (for sexually active subjects)

•1. Clinically significant abnormal physical and/or gynaecological examination
•2. Clinically significant abnormal laboratory findings
•3. Allergy to applicator material (polyethylene) or to gel polymer (polyoxyethylene - polyoxypropylene) or to latex
•4. Participation in any investigational study involving drugs, vaccines or microbicides in the last 30 days or participation in a study involving the invisible condom
•5. History of toxic shock syndrome
•6. HIV infection
•7. Bacterial vaginosis or Candida or Trichomonas at time of screening
•8. STDs (gonorrheae, chlamydia, syphilis, genital herpes, chancroid) at time of screening
•9. Breakthrough menstrual bleeding, or vaginal bleeding during or following sexual intercourse, in the last 3 months
•10. Intravenous (IV) drug use except for medical reasons in the last year
•11. Pregnant at enrolment or breast-feeding
•12. Having received antibiotics in the last 14 days
•13. Subjects considered as unreliable or unable to understand or follow the study protocol directions
•14. Use of an intrauterine device

发起方

aval University (Canada)