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Trial registered on ANZCTR

Registration number

ACTRN12625000283471p

Ethics application status

Not yet submitted

Date submitted

28/03/2025

Date registered

11/04/2025

Date last updated

11/04/2025

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]

MT300V-105

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Bacterial Vaginosis

Condition category

Condition code

Infection

Studies of infection and infectious agents

Renal and Urogenital

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]

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]

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 [1]

Visit 3 (Day 21-30), Visit 4 (Day 60), Visit 5 (Day 84) post-intervention commencement and at unscheduled/early termination visits if applicable.

Primary outcome [2]

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 [2]

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.

Secondary outcome [1]

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]

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]

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 [2]

Visit 3 (Day 21-30) post-intervention commencement

Secondary outcome [3]

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 [3]

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 [4]

Time to retreatment with antibiotics over the course of 168 days after initiation of co-administration with metronidazole.

Timepoint [4]

Any day over the course of 168 days after initiation of co-administration with metronidazole

Secondary outcome [5]

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 [5]

Visit 4 (Day 60), Visit 5 (Day 84) post-intervention commencement and at unscheduled/early termination visits if applicable.

Secondary outcome [6]

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 [6]

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.

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Metrodora Therapeutics Pty Ltd

Address [1]

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Metrodora Therapeutics Pty Ltd

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Bellberry Human Research Ethics Committee

Ethics committee address [1]

https://bellberry.com.au/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/04/2025

Approval date [1]

Ethics approval number [1]

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Mikhail Sarofim

Address

John Flynn Hospital, 42 Inland Drive, Tugun, QLD 4224

Country

Australia

Phone

+61 7 5598 9733

Fax

[email protected]

Contact person for public queries

Name

Mikhail Sarofim

Address

John Flynn Hospital, 42 Inland Drive, Tugun, QLD 4224

Country

Australia

Phone

+61 7 5598 9733

Fax

[email protected]

Contact person for scientific queries

Name

Dr. Gary Gelbfish

Address

Metrodora Therapeutics, 2502 Avenue I, Brooklyn, NY 11210

Country

United States of America

Phone

+19176136162

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically