A randomised double-blind phase 1 study to assess the pharmacokinetics of C2F5, C2G12 and C4E10 when administered together in a gel vehicle as a vaginal microbicide

York Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 30 人开始时间: 2009年1月26日最近更新: 2015年1月13日

适应症

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•1. Females
•2. Aged >=18 and <=45 years
•3. In good health as determined by medical history, physical examination and clinical judgement
•4. Willing and able to give written informed consent
•5. Available for the duration of the study
•6. Willing to undergo screening for HIV, hepatitis B & C, and sexually transmitted infections
•7. Willing to abstain from vaginal practices including receptive oral sex and sexual intercourse from 48 hours before the first dose of the study gel until after visit 5
•8. If physiologically fertile, using a reliable method of contraception for the two to three menstrual cycles covering the pre-study, and study dosing periods (methods defined as one of: consistent use of condoms with every act of sexual intercourse; combined oral contraceptive pill; intra-uterine contraceptive device; injectable contraceptive; progesterone implant)
•9. Willing to abstain from using any genital preparations, other than the study gel, during the period of gel administration until after visit 5
•10. Willing to abstain from using tampons during the period of gel administration until after visit 5
•11. Judged by clinician to be able, and likely, to comply with the procedures required as set out in the protocol
•12. Have been registered with a GP for at least the past 3 months
•13. Have access to a domestic refrigerator at home for the purposes of storing the study gel

•1. Untreated syphilis, gonorrhoea, trichomonas, chlamydia, Candida or bacterial vaginosis
•2. Clinically significant (out of the normal range and deemed clinically significant by the Chief Investigator [CI]) haematological, biochemical, or coagulation assay abnormalities on screening
•3. HIV infection, anti-HCV antibody positive, HbsAg positive
•4. Abnormal findings on pelvic examination, deemed clinically significant by the CI
•5. History of coagulation disorders
•6. Significant current general medical illness
•7. Irregular menstrual bleeding likely to cause vaginal bleeding during the dosing period as judged by the CI
•8. Current participation, or participation within the last 2 months in another clinical trial
•9. Treatment for cervical intraepithelial neoplasia (CIN) or other gynaecological instrumentation of the cervix within the past 3 months
•10. Pregnant, within 12 weeks postpartum, or breast feeding
•11. Unlikely to comply with protocol
•12. Have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
•13. Unable to fluently read and speak English to a level adequate for the full comprehension of procedures required in participation and consent

发起方

York Hospitals NHS Foundation Trust (UK)