Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis

NCT ID: NCT07241871

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-29
• Study Completion Date: 2023-03-29

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lactal Gel

Lactal Gel (Class IIa medical device): one tube daily administered as vaginal gel for 7 consecutive days, before bedtime

Group Type: EXPERIMENTAL

Lactal Gel (Class IIa medical device)

Intervention Type: DEVICE

One tube of Lactal Gel is daily administered for 7 consecutive days, before bedtime (not during menstrual bleeding period).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Analyze & Realize

NETWORK

Sponsor Role: collaborator

Rolf Kullgren AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christiane Bünemann-Buschmann, Dr. med

Role: PRINCIPAL_INVESTIGATOR

Frauenarztpraxis Berlin Gemeinschaftspraxis

Locations

Frauenarztpraxis Berlin Gemeinschaftspraxis

Berlin, , Germany

Countries

Germany

Other Identifiers

DRKS00038289

Identifier Type: REGISTRY

Identifier Source: secondary_id

RKU/006920

Identifier Type: -

Identifier Source: org_study_id