ISRCTN88319802已完成不适用
Magnetic resonance imaging study of the genital tract distribution and retention of microbicide 0.5% PRO 2000/5 Gel (P) in vivo: a partially blinded, randomised, two-arm, single-centre study
niversity of York (UK)0 个研究点目标入组 20 人开始时间: 2009年9月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- 性别
- All
入选标准
- •Female participants:
- •1. Aged 18 - 45 years. The upper age of 45 is felt to be important due to the need for female participants to have a regular menstrual cycle.
- •2. Sexually active with a current, stable, regular male partner
- •3. Not currently using condoms with this partner. This is important so that it is acceptable to randomise a participant to not using condoms.
- •4. Using hormonal contraception (except hormone-releasing intrauterine devices [IUDs])
- •5. Not known to be allergic to gadolinium
- •6. Willing and able to adhere to the study conditions and methodology
- •7. Willing and able to give written and signed informed consent to trial participation and procedures
- •8. Willing to use condoms in the context of the trial
- •9. Willing to have a human immunodeficiency virus (HIV) test (venous blood, HIV antibody test)
- •Male partners:
- •1. Aged 18 - 55 years. The upper age limit for men is felt to be appropriate to minimise age related conditions.
- •2. Independently reports that they are not currently using condoms with this partner
- •3. Not known to be allergic to gadolinium (as the male partner may come into contact with gadolinium during the act of unprotected coitus for study purposes)
- •4. Willing and able to adhere to the study conditions and methodology
- •5. Willing and able to give written informed consent to trial participation and procedures
- •6. Willing to use condoms in the context of the trial
- •7. Willing to have a HIV test (venous blood, HIV antibody test)
排除标准
- •Females only:
- •1. Pregnancy or lactation
- •2. Gynaecological instrumentation and procedures of the cervix/uterus in the last three months including cervical polypectomy, dilatation and curettage, endometrial biopsy, loop excision, etc.
- •3. Contraindication to MRI such as intracerebral aneurysm clip or implanted electronic devices
- •4. Currently participating in, or having participated in the last 3 months prior to the first screening visit, any other vaginal microbicide or mucosal vaccine study or clinical trial of an investigational agent
- •Females and males:
- •1. Untreated syphilis, gonorrhoea, trichomonas, chlamydia, candida or bacterial vaginosis
- •2. Current genital tract infection
- •3. HIV infection
- •4. Active hepatitis B or C infection
- •5. History of coagulation disorders
- •6. Significant haematological, biochemical, or coagulation assay abnormalities on screening
- •7. Unlikely to comply with protocol
研究者
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