CompletedPhase 2

Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)

205 participantsStarted 2011-08

Plain-language summary

The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women aged 18-45 years with a history of recurrent BV, defined as at least 3 documented episodes in the previous 12 months (including the current episode). * Current episode of BV as defined by subject-reported symptoms and Amsel's Criteria * Otherwise healthy Exclusion Criteria: * No active STIs and/or current UTI * Previous exposure to SPL7013 Gel * A Papanicolaou (Pap) smear result considered to be clinically significant (ie, high grade cervical intraepithelial squamous lesions \[HSIL\] on cytology or cervical intraepithelial neoplasia \[CIN\] grades of CIN2 or CIN3 on histology) in the previous 2 years or in accordance with local treatment guidelines.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of women who have experienced a recurrent episode of BV as a measure of efficacy

Timeframe: Day 112 +/- 5

Trial details

NCT IDNCT01437722

SponsorStarpharma Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-12

View on ClinicalTrials.gov More Recurrent Bacterial Vaginosis (BV) trials