Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis

NCT07241871 | Completed

• 2 other identifiers: RKU/006920DRKS00038289
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis

Keywords

Bacterial Vaginosis; medical device; lactic acid

Outcome Measures

Primary Outcomes (2)

• Percent of Bacterial Vaginosis (BV)-free subjects

  Percentage of BV-free subjects evaluated by Amsel criteria (at least of 3 of 4 criteria) and score

  day 11 ± 2 (final visit)

• Amsel parameter total sum

  Change in mean of the total sum of Amsel criteria scored as follows: * pH \>4.5=1; pH ≤4.5=0 * increase thin vaginal discharge=1; not increased thin vaginal discharge=0 * Whiff test positive=1; whiff test negative=0 * presence of clue cells in wet preparations=1; absence of clue cells in wet preparations=0

  day 11 ± 2 (final visit)

Secondary Outcomes (9)

• Subjective vaginal odor

  day 11 ± 2

• Subjective discomfort

  day 11 ± 2

• Subjective itching

  day 11 ± 2

• Investigator global evaluation

  day 11 ± 2

• Patient global evaluation

  day 11 ± 2

Other Outcomes (3)

• Usability: patient satisfaction of the device

  day 11 ± 2

• Usability: easy of use of the device

  day 11 ± 2

• Usability: willingness to use the device in the future

  day 11 ± 2

Study Arms (1)

Lactal Gel

EXPERIMENTAL

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

Device: Lactal Gel (Class IIa medical device)

Interventions

Lactal Gel (Class IIa medical device) DEVICE

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

Lactal Gel

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rolf Kullgren AB: lead
• Analyze & Realize: collaborator

Study Sites (1)

Frauenarztpraxis Berlin Gemeinschaftspraxis

Berlin, 10627, Germany

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Christiane Bünemann-Buschmann, Dr. med

  Frauenarztpraxis Berlin Gemeinschaftspraxis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 21, 2025
• Study Start: July 29, 2022
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The data that support the findings of this study will be available from the corresponding author, upon reasonable request after the result publication.
• Access Criteria: The data supporting the findings of this study will be made available to other researchers upon reasonable request from the corresponding author.

Locations

DE (1)