Pharmacokinetics of Intravaginal Lactoferrin Preparations

Phase 1

• Conditions: Bacterial Vaginosis; Infection - Studies of infection and infectious agents; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12619000295145
• Lead Sponsor: Metrodora Therapeutics Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-26
• Study Completion: 2021-09-08
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

1. In Part 1 and Part 2, premenopausal healthy females or pre-menopausal females with asymptomatic BV age 18 - 50 years old. In Part 3, pre-menopausal females with symptomatic BV age 18 - 45 years old who test positive for BV (AusDiagnostics Vaginitis and Vaginosis PCR test of Flora consistent with Bacterial Vaginosis”)
2. Able to understand and sign informed consent form prior to initiation of any study-related procedures
3. Able to commit to in-clinic monitoring over a 3-night period for scheduled visits and assessments
4. Able to return to the clinic daily for scheduled assessments for the 7 days of home dosing and for a Follow Up Visit 21 to 35 days after first dose of study medication
5. Willing to abstain from sexual activity 24 hours before dosing and Day -1 through Day 11
6. Body Mass Index (BMI) range of 18-35.0

Exclusion Criteria

1. Currently pregnant or lactating
2. Menopausal
3. Anticipate menstruation to occur during the in-clinic period of the study
4. Women with with greater than or equal to 4 episodes of treatment for symptomatic vaginal infections during the past year (women with a history of BV are allowed)
5. Currently receiving, or requiring during the study, other intravaginal treatment of any kind (e.g., tablet, suppository, cream, gel, foam, vaginal ring, douching, etc.). Intrauterine devices (e.g., IUD) are acceptable.
6. Gynecologic surgery in past 3 months
7. Received antifungal or antimicrobial therapy (systemic or intravaginal) within the last 14 days prior to study drug administration.
8. HIV positive or has previously tested positive for any STD within the last 30 days
9. Test positive by AusDiagnostics Vaginitis and Vaginosis PCR test at screening for trichomoniasis or candidiasis
10. Diagnosis of cervical intra-epithelial neoplasia or cervical carcinoma
11. Any abnormal anatomy or pathology of the vagina
12. Taking concomitant diuretics
13. History of allergy to bovine milk, bovine milk products, lactoferrin, or components of the MTbLF Drug Product.
14. 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.
15. Regular smokers unwilling to abstain from smoking for the duration of the 3-day in-clinic part of the study. Subjects who smoke but are willing and able to abstain for the 3-day in-clinic study duration can be included.
16. Asthma requiring preventer medication. Subjects with mild asthma requiring an occasional reliever inhaler can be included.

Study & Design

• Study Type: Interventional
• Study Design: Not specified