Bacterial Vaginosis Medical Study
Do you have Bacterial Vaginosis (BV)? We are recruiting for a medical study investigating the safety and tolerability of an intravaginal tablet co-administered with the current treatment for BV (metronidazole- an oral antibiotic).
Participation in this medical study is voluntary and will not affect your regular care at Key Health.
Table of Contents
What is BV?
BV is caused by the change in the balance of healthy bacteria in your vagina. BV is a common condition that is associated with bothersome symptoms and also carries increased risk of STI, PID, and obstetric complications.
What are the Symptoms of BV?
White/Greyish watery vaginal discharge
An unpleasant or ‘fishy’ vaginal smell
Mild irritation around your vagina and vulva
A burning sensation when urinating (weeing)
What is the purpose of the study?
Bacterial vaginosis (BV) is the leading vaginal disorder in women of childbearing age.
The study will assess the safety and efficacy of an intra-vaginal tablet used for 12 weeks co-administered for the first seven days with oral metronidazole. The study will do this by assessing the intra-vaginal tablet against a placebo. A placebo looks like the study medicine but does not contain any study medicine (active ingredient). Researchers use a placebo to see if a study medicine is safer than not taking anything at all.
There is one in four chance you will receive the placebo.
This is a double-blinded study, which means neither you nor the study team will know if you receive the investigational product or a placebo.
What is involved?
If you are deemed eligible for the study, your study participation will last 168 days (24 weeks)
This will include 6 clinic visits and 1 phone visit. It also includes collection of vaginal swabs at home weekly for 24 weeks.
Some of the clinic visits could last up to 3 hours. The study includes the following procedures:
Physical Exam: your study doctor will evaluate the basic function of your organs
Gynecological Exam: your study doctor will do assessment to check the pelvic organs
Colposcopy: a procedure that uses a microscope to check your cervix for
abnormalities
Vital Signs: your study doctor or nurse will check your height, weight, blood pressure, heart rate, oxygen levels, respiratory rate and temperature
Blood Tests
Urine Sample
Vaginal Swabs
Am I eligible for this study?
To take part in this study, you will need to meet all the following:
✅ You are aged 18-45
✅ You have bacterial vaginosis with symptoms such as off-white thin watery discharge/ a fishy odor
✅ You have had bacterial vaginosis in the past 3 years
✅ You have regular menses
If you meet any of the following criteria, you are ineligible to participate in the study:
❌ You are pregnant or planning to be pregnant in the next 24 weeks.
❌ You have received intravaginal antifungal or antibacterial therapy within 14 days prior to enrollment.
❌ You are currently suffering from Thrush.
For more details on study eligibility, please see Study Eligibility Information.
*Please note: additional eligibility criteria apply and will be discussed during the screening visit.
How can I take part in this study?
If you meet all the study eligibility criteria, please call or email
Alice Hawkes - Clinical Trials Coordinator for Key Health
Email: alice.hawkes@keyhealth.com.au
Phone: 0473 404 917