Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis

The objective of this study is to evaluate the safety and effectiveness of Lactal Gel, a new medical device that is administered vaginally for the treatment of bacterial vaginosis (BV). One group of patients aged 18 years or older who have been diagnosed with BV according to the Amsel criteria will be treated with the tested device for one week. This treatment will be in accordance with the instructions for use of the tested device and the standard usual care of the involved center. The administration of any preparations that may influence the study outcome within the previous three weeks (e.g., antibiotics, antimycotics, probiotics) is prohibited. To diagnose BV, the presence of at least three of the following is required:

• pH >4.5;
• increased thin vaginal discharge;
• amine odor when KOH (Potassium Hydroxide) solution is added to vaginal secretions (Whiff test);
• presence of clue cells in wet preparations.

Patients will be visited at baseline and at day 11 ± 2 (final visit).

The primary outcomes are:

• percentage of BV-free subjects at the final visit.
• Amsel criteria total score at the final visit.

Secondary outcomes are the following:

• patient evaluation for subjective odor, discomfort, and itching
• investigator and patient global evaluation of performance
• safety evaluation by collection of adverse events and by a global safety evaluation performed by patient and investigator
• assessment of patient satisfaction and usability of the tested device

If the results of this study are positive, the new medical device under development has the potential to become a valuable tool for gynecologists. It will be useful in cases where antibiotic treatment is not the preferred option for treating bacterial vaginosis.

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 criterion)
• Readiness not to participate in another clinical study during this study
• Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at baseline visit

Exclusion criteria

• Known allergy or hypersensitivity to the components of the IMD (self-reported)
• Manifested or suspected Candida infection or any other vaginal mycosis
• Trichomoniasis
• Urogenital (dipstick testing), anal or rectal infection within the 3 weeks prior to (self-reported) / at baseline
• History of recurrent genital herpes (self-reported)
• Lesions/infections in the vaginal area
• Use of preparations that may influence the study outcome within the last 3 weeks prior to Baseline and during the study (e.g. antibiotics, antimycotics, probiotics, corticosteroids etc.)
• History in the past 6 months prior to baseline or presence of a sexually transmitted disease (self-reported)
• History or presence of any other clinically significant known (self-reported) condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject
• Pregnancy, nursing or within first 3 months post-partum
• History of or current abuse of drugs, alcohol or medication
• Participation in another study during the last 30 days prior to baseline
• Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures