CompletedNot Applicable

Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis

Germany50 participantsStarted 2022-07-29

Plain-language summary

The aim of this study is to find out how well the medical device Lactal Gel works and how safe it is. The product will be used to treat bacterial vaginosis in a group of fifty women aged 18 years or older. All participants will receive the one-week treatment as part of their usual medical care. Each participant will have two visits: one at the beginning of the study (the initial assessment) and another at day 11 (the final visit). During these visits, the doctor will: * Perform a normal medical check-up * Diagnose bacterial vaginosis using the Amsel criteria (which include checking vaginal pH, appearance of discharge, odor, and microscopic examination) * Ask about symptoms such as odor, discomfort, and itching * Evaluate, together with the patient, how well the treatment is working * Assess the patient's satisfaction and how easy the product is to use * Check that the treatment is safe and well tolerated The results of this study will help doctors choose the most effective and safest treatment for bacterial vaginosis.

Who can participate

Age range

18 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: Participation was based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study. * Age ≥ 18 years old, including women of non- childbearing potential such as women after menopause, i.e 12 months after last menstruation * Newly diagnosed BV episode, based on Amsel criteria (Amsel et al., 1983), i.e. presence of three of the following criteria: increased homogeneous thin vaginal discharge; pH of the secretion \>4.5; amine odor when potassium hydroxide (KOH) 10% solution is added to a drop of vaginal secretions; presence of clue cells in wet preparations. * Suffering from symptoms associated with BV, such as unusual vaginal discharge, odour and discomfort * Having access to a smartphone or a computer with an internet access and familiar with the use thereof * to use the Investigational Medical Device (IMD) as recommended (in particular, for 7 consecutive days during the non-bleeding period of the menstrual cycle) * to avoid the use of any other interventional options for BV during the study (other than the IMD) * to avoid the use of any other intravaginal product (e.g. suppositories, gels, foams, lubricants, disinfectants, chemically based contraceptives etc.) during the study * to fill in the electronic Diary (eDiary) * Commitment to use contraception methods (with the exception of those defined in the previous inclusion crite…

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

Percent of Bacterial Vaginosis (BV)-free subjects

Timeframe: day 11 ± 2 (final visit)

Amsel parameter total sum

Timeframe: day 11 ± 2 (final visit)

Trial details

NCT IDNCT07241871

SponsorRolf Kullgren AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-29

View on ClinicalTrials.gov More Bacterial Vaginosis trials