ISRCTN96104919已完成2 期
Randomized controlled trial evaluating the efficacy of carrageenan as a topical microbicide against HPV Infection
Canadian Institutes of Health Research (CIHR) (Canada)0 个研究点目标入组 461 人开始时间: 2012年3月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 461
研究概览
简要总结
2019 Interim results article in https://pubmed.ncbi.nlm.nih.gov/29684633/ interim results (added 23/10/2020) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34487919/ (added 07/09/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37396806/ (added 04/07/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Added 01/03/2017: Current inclusion criteria as of 17/11/2014:
- •1. Female aged 18 or older living in Montreal
- •2. Plan to remain in Montreal for at least the next year
- •3. Have had vaginal sex with a male partner during the last 3 months and expect that they
- •will do so again in the next 3 months, regardless of whether or not the male partner(s) will
- •4. Not currently in a relationship that has lasted longer than 6 months
- •5. Be willing to follow study instructions
- •6. Understand French or English
- •7. Be willing to comply with follow-up for at least 12 months
- •8. Have an intact uterus
- •9. Have no history of cervical lesions/cancer or genital warts
- •10. Not be pregnant or planning to immediately become pregnant and not currently breastfeeding
- •11. Not had a recent (within the last 6 weeks) pregnancy, abortion, or genital surgery
- •12. Be using a medically acceptable method of contraception and intend to use it for the
- •duration of the trial
- •13. Have no HIV infection
- •14. Have no known allergy or hypersensitivity to vaginal lubricants
- •15. Have no allergy to all of the ingredients of the study product or placebo
- •Previous inclusion criteria from 12/09/2013:
- •1. Female aged 18-29 living in Montreal
- •2. Plan to remain in Montreal for at least the next year
- •3. Have had vaginal sex with a male partner during the last 3 months and expect that they will do so again in the next 3 months, regardless of whether or not the male partner(s) will change
- •4. Not currently in a relationship that has lasted longer than 6 months
- •5. Be willing to follow study instructions
- •6. Understand French or English
- •7. Be willing to comply with follow-up for at least 12 months
- •8. Have an intact uterus
- •9. Have no history of cervical lesions/cancer or genital warts
- •10. Not be pregnant or planning to immediately become pregnant and not currently breast-feeding
- •11. Not had a recent (within the last 6 weeks) pregnancy, abortion, or genital surgery
- •12. Be using a medically acceptable method of contraception and intend to use it for the duration of the trial
- •13. Have no HIV infection
- •14. Have no known allergy or hypersensitivity to vaginal lubricants
- •15. Have no allergy to all of the ingredients of the study product or placebo
- •Original inclusion criteria:
- •1. Female aged 18-24 living in Montreal
- •2. Plan to remain in Montreal for at least the next year
- •3. Have had vaginal sex with a male partner during the last 30 days and expect that they will do so again in the next month, regardless of whether or not the male partner(s) will change
- •4. Not currently in a relationship that has lasted longer than 3 months
- •5. Be willing to follow study instructions
- •6. Understand French or English
- •7. Be willing to comply with follow-up for at least 12 months
- •8. Have an intact uterus
- •9. Have no history
排除标准
- •Does not meet inclusion criteria
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