Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000283471
Ethics application status
Approved
Date submitted
28/03/2025
Date registered
11/04/2025
Date last updated
29/05/2025
Date data sharing statement initially provided
11/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and efficacy of Metrodora Therapeutics’ Low Iron MTbLF (Low Iron MTbLF) formulations with or without Essential Elements Zinc and Manganese during coadministration with oral antibiotic and for an additional 11 weeks following antibiotic treatment on recurrence of symptomatic bacterial vaginosis (BV)
Scientific title
A double-blind, randomized trial to assess the safety and efficacy of Metrodora Therapeutics’ Low Iron MTbLF (Low Iron MTbLF) (MET-013), Essential Elements Zinc and Manganese (MET-014), Low Iron MTbLF with Zinc and Manganese (MET-012) or Placebo (MET-015) co-administered for the first 7 days with oral metronidazole and then for an additional 11 weeks on symptomatic bacterial vaginosis (BV) recurrence
Secondary ID [1] 314063 0
MT300V-105
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial Vaginosis 336810 0
Condition category
Condition code
Infection 333302 333302 0 0
Studies of infection and infectious agents
Renal and Urogenital 333303 333303 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 330642 0
Prevention
Comparator / control treatment
The study is placebo controlled, in Arm 4, with MET-015. Placebo is a tablet that is administered intravaginally and contains mannitol and other common pharmaceutical excipients.
In MT300V-105 Arm 4 (control arm) patients will administer Placebo (MET-015) co-administered for the first 7 days with oral metronidazole and then for an additional 11 weeks. Patients will take one tablet (400mg) of metronidazole twice a day for the first 7 days of the study and administer placebo for an additional 11 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 340880 0
Assessment of safety of study drug co-administered with antibiotics for 7 days and followed by administration of study drug for an additional 11 weeks.
Timepoint [1] 340880 0
Adverse events and serious adverse events will be assessed from the time the patient provides informed consent through the end of the study. Physical exam at Visit 1 (Screening/Randomization visit), Visit 3 (Day 21-30), Visit 4 (Day 60), Visit 5 (Day 84), Visit 6 (Day 126), Visit 7 (Day 168) post-intervention commencement and at unscheduled/early termination visits if applicable. Gynecological exam at Visit 1 (Screening/Randomization visit), Visit 3 (Day 21-30), Visit 4 (Day 60), Visit 5 (Day 84), Visit 6 (Day 126), Visit 7 (Day 168) post-intervention commencement and at unscheduled/early termination visits if applicable. Colposcopy at Visit 1 (Screening/Randomization visit), Visit 5 (Day 84) post-intervention commencement and at early termination visits if applicable and only if it occurs prior to Visit 5 (Day 84) post-intervention commencement. Vital signs at Visit 1 (Screening/Randomization visit), Visit 3 (Day 21-30), Visit 4 (Day 60), Visit 5 (Day 84), Visit 6 (Day 126), Visit 7 (Day 168) post-intervention commencement and at unscheduled/early termination visits if applicable. Clinical Laboratory tests at Visit 1 (Screening/Randomization visit), Visit 5 (Day 84) post-intervention commencement and at unscheduled/early termination visits if occurs while subject is receiving study drug.
Primary outcome [2] 340881 0
Proportion of subjects who meet the criteria for symptomatic BV between Visit 3 and Visit 5, inclusive. The definition for symptomatic BV is Amsel greater or equal to 3 (including clue cells greater than 20%) and Nugent greater or equal to 4. This outcome will be assessed using both Amsel criteria and Nugent score and will be assessed as a composite outcome.
Timepoint [2] 340881 0
Visit 3 (Day 21-30), Visit 4 (Day 60), Visit 5 (Day 84) post-intervention commencement and at unscheduled/early termination visits if applicable.
Secondary outcome [1] 445336 0
Proportion of subjects who meet the criteria for symptomatic BV between Visit 3 and Visit 7, inclusive. The definition for symptomatic BV is Amsel greater or equal to 3 (including clue cells greater than 20%) and Nugent greater or equal to 4. This outcome will be assessed using both Amsel criteria and Nugent score and will be assessed as a composite outcome.
Timepoint [1] 445336 0
Visit 3 (Day 21-30), Visit 4 (Day 60), Visit 5 (Day 84), Visit 6 (Day 126), Visit 7 (Day 168) post-intervention commencement and at unscheduled/early termination visits if applicable.
Secondary outcome [2] 445337 0
Proportion of subjects who do not meet the criteria for symptomatic BV at Visit 3 but meet the criteria for symptomatic BV after Visit 3 and by Visit 5. The definition for symptomatic BV is Amsel greater or equal to 3 (including clue cells greater than 20%) and Nugent greater or equal to 4. This outcome will be assessed using both Amsel criteria and Nugent score and will be assessed as a composite outcome.
Timepoint [2] 445337 0
Visit 4 (Day 60), Visit 5 (Day 84) post-intervention commencement and at unscheduled/early termination visits if applicable.
Secondary outcome [3] 445341 0
Proportion of subjects who achieve FDA defined clinical cure by Visit 3 (Day 21 - 30). FDA clinical cure is defined as resolution of abnormal vaginal discharge, a negative whiff test, and presence of clue cells at less than 20 percent of the total epithelial cells.
Timepoint [3] 445341 0
Visit 3 (Day 21-30) post-intervention commencement
Secondary outcome [4] 445339 0
Time to symptomatic BV recurrence over the course of 168 days after co-administration with metronidazole. The definition for symptomatic BV is Amsel greater or equal to 3 (including clue cells greater than 20%) and Nugent greater or equal to 4. This outcome will be assessed using both Amsel criteria and Nugent score and will be assessed as a composite outcome.
Timepoint [4] 445339 0
Visit 3 (Day 21-30), Visit 4 (Day 60), Visit 5 (Day 84), Visit 6 (Day 126), Visit 7 (Day 168) post-intervention commencement and at unscheduled/early termination visits if applicable.
Secondary outcome [5] 445338 0
Proportion of subjects who do not meet the criteria for symptomatic BV at Visit 3 but meet the criteria for symptomatic BV after Visit 3 and by Visit 7. The definition for symptomatic BV is Amsel greater or equal to 3 (including clue cells greater than 20%) and Nugent greater or equal to 4. This outcome will be assessed using both Amsel criteria and Nugent score and will be assessed as a composite outcome.
Timepoint [5] 445338 0
Visit 4 (Day 60), Visit 5 (Day 84), Visit 6 (Day 126), Visit 7 (Day 168) post-intervention commencement and at unscheduled/early termination visits if applicable.
Secondary outcome [6] 445340 0
Time to retreatment with antibiotics over the course of 168 days after initiation of co-administration with metronidazole.
Timepoint [6] 445340 0
Any day over the course of 168 days after initiation of co-administration with metronidazole

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA

Funding & Sponsors
Funding source category [1] 318571 0
Commercial sector/Industry
Name [1] 318571 0
Metrodora Therapeutics Pty Ltd
Country [1] 318571 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Metrodora Therapeutics Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320969 0
None
Name [1] 320969 0
Address [1] 320969 0
Country [1] 320969 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317171 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 317171 0
Ethics committee country [1] 317171 0
Australia
Date submitted for ethics approval [1] 317171 0
16/04/2025
Approval date [1] 317171 0
15/05/2025
Ethics approval number [1] 317171 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140234 0
Dr Mikhail Sarofim
Address 140234 0
John Flynn Hospital, 42 Inland Drive, Tugun, QLD 4224
Country 140234 0
Australia
Phone 140234 0
+61 7 5598 9733
Fax 140234 0
Email 140234 0
[email protected]
Contact person for public queries
Name 140235 0
Mikhail Sarofim
Address 140235 0
John Flynn Hospital, 42 Inland Drive, Tugun, QLD 4224
Country 140235 0
Australia
Phone 140235 0
+61 7 5598 9733
Fax 140235 0
Email 140235 0
[email protected]
Contact person for scientific queries
Name 140236 0
Dr. Gary Gelbfish
Address 140236 0
Metrodora Therapeutics, 2502 Avenue I, Brooklyn, NY 11210
Country 140236 0
United States of America
Phone 140236 0
+19176136162
Fax 140236 0
Email 140236 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.