ACTRN12619000196145已完成3 期
Treating male partners of women with bacterial vaginosis (BV) to reduce recurrence: randomised controlled trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 328
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Females will be included if they fulfil the following criteria:
- •i) Are aged 18 years to pre-menopausal (defined as still menstruating within the last 12 months); and
- •ii) have symptomatic BV defined as 3 or 4 Amsel’s criteria and a Nugent score (NS) of 4–10; and
- •iii) have a regular male partner for the prior 8 weeks who is willing and eligible to participate; and
- •iv) are being treated with a first line recommended antimicrobial therapy for BV (including the following 3 options: 7 days of oral metronidazole 400mg bd is the preferred option but if not tolerated or is contraindicated 7 days of topical vaginal clindamycin cream or 5 days of intravaginal metro gel are acceptable; and
- •v) have sufficient English language proficiency to understand the study requirements; and
- •vi) provide written informed consent; and
- •vii) are willing and able to comply with protocol requirements including clinic visits at 4 and 12 weeks ; and
- •viii) do not have any of the exclusion criteria listed below.
- •Males nominated as the regular partner of a woman fulfilling inclusion criteria will be eligible if they:
- •i) Are aged 18 years or above; and
- •ii) enrol within a week of their partner with confirmed BV; and
- •iii) have sufficient English language proficiency to understand the study requirements; and
- •iv) provide written informed consent; and
- •v) are able to comply with protocol requirements; and
- •vi) do not have any of the exclusion criteria or contraindications listed for metronidazole.
排除标准
- •Participants will be deemed ineligible for the study if they meet any of the following exclusion criteria:
- •i) are a current sex worker; or
- •ii) have concurrent sexual partners; or
- •iii) are known to be HIV positive
研究者
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