NCT07241871

Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis

Open-Label Post Market Clinical Follow up Investigation to Evaluate the Clinical Performance and Safety / Tolerability of Lactal Gel for Treatment of Bacterial Vaginosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Rolf Kullgren AB · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DEVICE	Lactal Gel (Class IIa medical device)	One tube of Lactal Gel is daily administered for 7 consecutive days, before bedtime (not during menstrual bleeding period).

Timeline

• Start date: 2022-07-29
• Primary completion: 2023-03-29
• Completion: 2023-03-29
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

1 site across 1 country: Germany