Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis (NCT04489290) | Clinical Trial Compass
UnknownNot Applicable
Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis
Sweden, United Kingdom83 participantsStarted 2021-02-12
Plain-language summary
This is a randomised, double-blind clinical investigation to evaluate the efficacy and safety of D005 vaginal mousse compared to placebo, in women with bacterial vaginosis.
The study will be conducted at one site in Scotland, United Kingdom and at six different sites in Sweden. The study population will consist of approximately 83 female subjects.
Who can participate
Age range
18 Years – 60 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
. Willingness and ability to provide informed consent
. Female in fertile age
. Age ≥18 years
. Bacterial vaginosis, as defined by the following criteria (Amsel criteria):
. A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of potassium hydroxide (KOH)
. Presence of clue cells (≥20%)
. Off-white (milky or gray), thin, homogeneous discharge
. Refrain from using any intravaginal products during the investigation period
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.
. Hypersensitivity or allergy to the investigational devices or to chemically related products
. Current use of an intrauterine device.
. Current pregnancy or intention to become pregnant within 1 month after treatment
. Antibiotic treatment within 2 weeks before treatment
. Signs of other infections (such as chlamydia, gonorrhoea, trichomonas, candida, HSV or HPV) requiring specific antibiotic, antifungal or other treatment at screening.
. Immunosuppression therapy (Allergy medications allowed) at the discretion of the PI
. Existing or suspected vaginal or cervical cancer or ulcer
. Unprotected vaginal sex within 24 hours prior to Visit 1