None listed
Conditions
Brief summary
This research study in BV patients is testing the safety, tolerability, and efficacy of tablet formulations of an investigational drug called Metrodora Therapeutics Low Iron bovine Lactoferrin (Low Iron MTbLF) with or without the Essential Elements Zn and Mn, when it is given intravaginally (into the vagina) during patients’ primary treatment with oral antibiotics and for 11 weeks post 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 goals of this study are to evaluate a trend on the effect of Low Iron MTbLF-with and without Essential Elements Zn and Mn- for the prevention of recurrence of BV, the delay in time to retreatment of recurrent BV with antibiotics, and the evaluation of different diagnostics to follow recurrence during the treatment and follow up period. BV patients will receive antibiotic treatment (oral metronidazole daily for 7 days) per standard-of-care for symptomatic BV with co-administration of study drug and for 11 weeks after antibiotics. Patients will self-administer daily doses of study drug for 12 weeks. They will self-collect four vaginal swabs weekly at home for the duration of the 12-week study drug administration and then the 12-week follow up period. A series of vaginal swabs will be collected by a healthcare practitioner during 3 in-clinic visits that will take place in the 12-week dosing period and during the 2 in-clinic visits that will take place in the 12-week follow up period. Patients will use a patient diary to record symptoms, dosing of study drug and other study-related information daily during study drug administration (weeks 1 to 12) and twice a week during weeks 13-24.
Interventions
Study MT300V-105 is a three-arm intervention study controlled by a fourth, placebo arm. In Arm 1, patients are dosed with Low Iron MTbLF (MET-013), in Arm 2 with Essential Elements Zn and Mn (MET-014) and in Arm 3 with Low Iron MTbLF with Zn and Mn (MET-012). Oral metronidazole is co-administered with study drug in all three arms for the first 7 days then study drug is continued for an additional 11 weeks. Metronidazole is administered orally as a tablet of 400 mg twice a day. Study drugs will b
Study MT300V-105 is a three-arm intervention study controlled by a fourth, placebo arm. In Arm 1, patients are dosed with Low Iron MTbLF (MET-013), in Arm 2 with Essential Elements Zn and Mn (MET-014) and in Arm 3 with Low Iron MTbLF with Zn and Mn (MET-012). Oral metronidazole is co-administered with study drug in all three arms for the first 7 days then study drug is continued for an additional 11 weeks. Metronidazole is administered orally as a tablet of 400 mg twice a day. Study drugs will be administered as tablets intravaginally (into the vagina) using a single use applicator. MET-013 and MET-012 tablets contain 300 mg of Low Iron MTbLF and MET-012 additionally contains trace amounts of Essential Elements Zn and Mn. MET-014 tablets contain trace amounts of Essential Elements Zn and Mn. Patients will self-administer 84 daily doses of study drugs. Adherence to dosing will be monitored by clinical personnel through daily patient diary screening and study drug accountability (tablet count) during 3 visits over the course of the 12-week dosing period.
Sponsors
Metrodora Therapeutics Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Premenopausal females aged 18-45 with symptomatic BV (Amsel greater or equal to 3 including clue cells greater than 20%) at screening. Amsel criteria include: a. Off-white (milky or grey), thin, homogeneous discharge with minimal or absent pruritus and inflammation of the vulva and vagina b. The presence of clue cells greater than 20 percent of the total epithelial cells on microscopic examination of the saline wet mount c. Vaginal secretion pH of greater than 4.5 d. A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of KOH 2. Self-reports that they have been treated with antibiotics for a presumptive diagnosis of BV at least once in the last 3 years 3. Able to understand and sign informed consent form prior to initiation of any study-related procedures 4. 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 5. Women of childbearing potential must agree to use a reliable method of birth control for the duration of the study [Reliable methods of birth control include tubal ligation or occlusion, male partner with a vasectomy, a steroidal contraceptive (oral, injectable or implantable), Intrauterine Device (IUD), or abstinence or other methods deemed reliable in the Investigator's opinion]
Exclusion criteria
Patients presenting with any of the following will not be included in the study: 1. Anticipate having 6 or more different sexual partners over the 24-week course of the study 2. Currently pregnant or planning on becoming pregnant while on the study, lactating or within the first 2 months postpartum 3. Inability to comply with study procedures and requirements 4. Symptoms of other urogenital infections such as vulvovaginal candidiasis or Trichomonas at screening 5. Presence of herpes simplex virus active lesions 6. Self-reports having previously tested positive for any sexually transmitted infection (STI) within the last 30 days 7. Recurrent candidiasis/thrush (greater or equal to 4 episodes within the last 12 months) 8. Currently receiving, or requiring during the study, other intravaginal treatment of any kind (e.g., tablet, suppository, cream, gel, foam, vaginal ring, etc.). 9. Gynecologic surgery in the past 2 months, including IUD insertion or removal, pelvic surgery, cervical cryotherapy or cervical laser treatment 10. Received systemic or intravaginal antifungal or antibacterial therapy within the last 14 days prior to screening including over the counter acidifying agents (e.g. boric acid vaginal treatments) and Fleurstat BV gel. 11. Male partner is receiving antibiotic treatment to reduce risk of BV recurrence 12. Use of disulfiram within the 2 weeks prior to screening or other contraindication to use of oral metronidazole 13. Any condition requiring regular periodic use of systemic antibiotics during participation in the study 14. Under treatment for cervical intra-epithelial neoplasia or cervical carcinoma 15. Patients with another vaginal or vulvar condition, endometriosis or pelvic inflammatory disease (PID), which would confound the interpretation of clinical response 16. Taking dietary supplements within 1 week of screening and during the study (including over the counter, herbal, or natural medicines) containing minerals (i.e., zinc or manganese). Multivitamins are allowed. 17. History of allergy to bovine milk, bovine milk products, lactoferrin, zinc, manganese or components of the study drug. Patients with lactose intolerance are eligible for the study. 18. 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