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临床试验/PACTR2010060002133418
PACTR2010060002133418尚未招募未知

A study to determine the feasibility of conducting a microbicide trial of daily vaginal gel and to inform the way adherence should be assessed

Medical Research Council0 个研究点目标入组 225 人开始时间: 2010年5月26日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
入组人数
225

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 99 Year(s)(—)
性别
Female

入选标准

  • Women aged 18 years and above at enrolment
  • Likely to be sexually active at entry and during follow-up
  • Willing to use study gel as instructed
  • Willing to return applicators every week day
  • Willing to attend the clinic every 4 weeks and be interviewed
  • Willing to be followed up and interviewed if she defaults
  • Willing to receive health education about condoms
  • Willing to undergo pregnancy tests on a monthly basis
  • Willing and able to give informed consent

排除标准

  • Using a product in a trial, or otherwise e.g. licensed spermicide, that is likely to impact on the outcome of this study and she is unwilling to stop use for the duration of study
  • Unable to agree a reliable method of contact with the field team
  • Likely to move out of the area within the next 3 months
  • Pregnant (including positive pregnancy test at enrolment)
  • Has clinical condition considered by the study management group to make enrolment inadvisable
  • Considered by the study personnel to be unlikely to be able to comply with the study procedures
  • Previously enrolled on MDP301 trial

研究者

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