ACTRN12622000548730已完成1 期
Single arm, Phase 1b, repeat dose study to assess the safety and preliminary evidence of efficacy of Metrodora Therapeutics’ bovine lactoferrin (low iron MTbLF) on the recurrence of bacterial vaginosis (BV) in premenopausal females following treatment with vaginal metronidazole
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
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
- Prevention
- 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. Premenopausal females aged 18-45 with a diagnosis of BV confirmed by at least 3 out of 4 positive Amsel criteria (must collect all 4 Amsel criteria):
- •a. Off-white (milky or gray), thin, homogeneous discharge with minimal or absent pruritus and inflammation of the vulva and vagina
- •b. Vaginal secretion pH of greater than 4.5
- •c. A fishy odor (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of KOH
- •d. The presence of clue cells greater than 20 percent of the total epithelial cells on microscopic examination of the saline wet mount
- •2. Nugent score of 4 to 10 prior to antibiotic treatment
- •3. Willing to complete a course of metronidazole (vaginal for 5 days)
- •4. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks, and adverse effects
- •5. Regular predictable menstrual cycles or amenorrheic for at least 3 months due to use of a long-acting progestin or continuous use of oral contraceptives
- •6. Must be of non-childbearing potential or if of childbearing potential, must agree to use a reliable method of birth control for 3 months after last dose of study drug treatment. (Reliable methods of birth control include tubal ligation, male partner with a vasectomy, a steroidal contraceptive (oral, patch, injectable or implantable), IUD, condoms or abstinence)
排除标准
- •1. Anticipate having 6 or more different sexual partners over the 24 week course of the study
- •2. Currently pregnant, lactating or within the first 2 months postpartum
- •3. Planning to donate ova within 3 months of study completion
- •4. Urogenital infection at screening
- •Note: Urogenital infection includes urinary tract infection, Trichomonas (T.) vaginalis, Neisseria (N.) gonorrhoeae, Chlamydia (C.) trachomatis, Mycoplasma genitalium, Treponema pallidum or vulvo-vaginal candidiasis
- •5. Positive for HIV or Hepatitis B or C, or herpes simplex virus active lesions at screening, or has previously tested positive for any STD within the last 30 days
- •6. Currently receiving, or requiring during the study, other intravaginal treatment of any kind (e.g., tablet, suppository, cream, gel, foam, vaginal ring, etc.)
- •7. Gynecologic surgery in past 2 months, including IUD insertion or removal, pelvic surgery, cervical cryotherapy or cervical laser treatment
- •8. Received antifungal or antibacterial therapy other than metronidazole (systemic or intravaginal) within the last 14 days prior to enrolment
- •9. Use of disulfiram within past 2 weeks or other contraindication to use of vaginal metronidazole
- •10. Any condition requiring regular periodic use of systemic antibiotics during participation in the study
- •11. Under treatment for cervical intra-epithelial neoplasia or cervical carcinoma
- •12. Patients with another vaginal or vulvar condition, which would confound the interpretation of clinical response
- •13. Taking concomitant diuretics or probiotics or use of vaginal acidifying agents
- •14. Failure to complete prescribed days of metronidazole with the last dose taken no later than 48 hours prior to allocation to treatment
- •15. History of allergy to bovine milk, bovine milk products, lactoferrin, or components of the low iron MTbLF Drug Product. Patients with oral lactose intolerance are eligible for the study
- •16. 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
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