ACTRN12619000295145终止1 期
Evaluation of the Effects of Various Intravaginal MTbLF (bovine lactoferrin) Formulations on bLF Metabolism in Vaginal Fluid in pre-menopausal females with symptomatic bacterial vaginosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 18
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Female
入选标准
- •1. In Part 1 and Part 2, premenopausal healthy females or pre-menopausal females with asymptomatic BV age 18 - 50 years old. In Part 3, pre-menopausal females with symptomatic BV age 18 - 45 years old who test positive for BV (AusDiagnostics Vaginitis and Vaginosis PCR test of Flora consistent with Bacterial Vaginosis”)
- •2. Able to understand and sign informed consent form prior to initiation of any study-related procedures
- •3. Able to commit to in-clinic monitoring over a 3-night period for scheduled visits and assessments
- •4. Able to return to the clinic daily for scheduled assessments for the 7 days of home dosing and for a Follow Up Visit 21 to 35 days after first dose of study medication
- •5. Willing to abstain from sexual activity 24 hours before dosing and Day -1 through Day 11
- •6. Body Mass Index (BMI) range of 18-35.0
排除标准
- •1. Currently pregnant or lactating
- •2. Menopausal
- •3. Anticipate menstruation to occur during the in-clinic period of the study
- •4. Women with with greater than or equal to 4 episodes of treatment for symptomatic vaginal infections during the past year (women with a history of BV are allowed)
- •5. Currently receiving, or requiring during the study, other intravaginal treatment of any kind (e.g., tablet, suppository, cream, gel, foam, vaginal ring, douching, etc.). Intrauterine devices (e.g., IUD) are acceptable.
- •6. Gynecologic surgery in past 3 months
- •7. Received antifungal or antimicrobial therapy (systemic or intravaginal) within the last 14 days prior to study drug administration.
- •8. HIV positive or has previously tested positive for any STD within the last 30 days
- •9. Test positive by AusDiagnostics Vaginitis and Vaginosis PCR test at screening for trichomoniasis or candidiasis
- •10. Diagnosis of cervical intra-epithelial neoplasia or cervical carcinoma
- •11. Any abnormal anatomy or pathology of the vagina
- •12. Taking concomitant diuretics
- •13. History of allergy to bovine milk, bovine milk products, lactoferrin, or components of the MTbLF Drug Product.
- •14. Received another investigational agent within 4 weeks prior to screening or within 5 half-lives of the investigational agent, whichever is greater, or planned receipt of an investigational agent not specified by this protocol during the study period.
- •15. Regular smokers unwilling to abstain from smoking for the duration of the 3-day in-clinic part of the study. Subjects who smoke but are willing and able to abstain for the 3-day in-clinic study duration can be included.
- •16. Asthma requiring preventer medication. Subjects with mild asthma requiring an occasional reliever inhaler can be included.
研究者
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