None listed
Conditions
Brief summary
This research study in BV patients is testing the safety, tolerability, preliminary evidence of efficacy and pharmacokinetics (the levels of drug in the blood and in vaginal fluid) of a bilayer tablet formulation of a drug called Metrodora Therapeutics Low Iron bovine Lactoferrin (Low Iron MTbLF) when it is given Intravaginally (into the vagina) after patients’ completion of primary treatment with antibiotics. Lactoferrin is a naturally occurring protein present in milk, saliva, tears, and other bodily fluids that has antimicrobial activity and may have an important therapeutic effect for the treatment of recurrent Bacterial Vaginosis (BV). The overall goal of this study is to optimize the duration of Low Iron MTbLF treatment post antibiotics for the prevention of recurrence of BV and the evaluation of different diagnostics to follow recurrence during the treatment period. BV patients will receive antibiotic treatment (metronidazole 0.75% intravaginal daily for 5 days at bedtime) for symptomatic BV. Then, they will self-administer daily doses of study medication for 12 weeks. They will self-collect three vaginal swabs weekly at home for the duration of the 12-week treatment and then the 12-week follow up period. A series of vaginal swabs and blood samples will be collected by a healthcare practitioner during 4 in-clinic visits that will take place in the 12-week treatment period and at the end of the study on week 24. Patients will use a patient diary to record symptoms, dosing of study medication and other study-related information daily during treatment (weeks 1 to 12) and twice a week during weeks 13-24.
Interventions
Metrodora Therapeutics Low Iron bovine Lactoferrin [Low Iron MTbLF] will be administered as a bilayer tablet intravaginally (into the vagina) using a single use applicator. Each tablet contains 300 mg of Low Iron MTbLF (bovine lactoferrin). Patients will self-administer 84 daily doses of study medication. Adherence to dosing will be monitored by clinical personnel through daily patient diary screening and study drug accountability (tablet count) during 4 visits over the course of the 12-week tre
Metrodora Therapeutics Low Iron bovine Lactoferrin [Low Iron MTbLF] will be administered as a bilayer tablet intravaginally (into the vagina) using a single use applicator. Each tablet contains 300 mg of Low Iron MTbLF (bovine lactoferrin). Patients will self-administer 84 daily doses of study medication. Adherence to dosing will be monitored by clinical personnel through daily patient diary screening and study drug accountability (tablet count) during 4 visits over the course of the 12-week treatment period.
Sponsors
Metrodora Therapeutics Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
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
Outcome results
None listed