Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis

Rolf Kullgren AB

Status

Completed

Conditions

Bacterial Vaginosis

Treatments

Device: Lactal Gel (Class IIa medical device)

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT07241871

DRKS00038289 (Registry Identifier)

RKU/006920

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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