Bacterial VaginosisNCT07241871
Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis
A study testing Lactal Gel (Class IIa medical device) in people with Bacterial Vaginosis, run by Rolf Kullgren AB at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Lactal Gel (Class IIa medical device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 29 Jul 2022to 29 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label Post Market Clinical Follow up Investigation to Evaluate the Clinical Performance and Safety / Tolerability of Lactal Gel for Treatment of Bacterial Vaginosis
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.
Read more
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.
Read the 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
- Being tested
- Lactal Gel (Class IIa medical device)
- Keywords
- Bacterial Vaginosis, medical device, lactic acid
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Lactal Gel | Experimental | Lactal Gel (Class IIa medical device): one tube daily administered as vaginal gel for 7 consecutive days, before bedtime Receives: Device: Lactal Gel (Class IIa medical device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: day 11 ± 2 (final visit)
Secondary outcomes (9)
Subjective vaginal odor
Change of subjective vaginal odor evaluated by the patient using Visual Analogue Score (VAS): 0-10 score
Measured: day 11 ± 2
Subjective discomfort
Change of subjective discomfort evaluated by the patient using VAS (0-10 score)
Measured: day 11 ± 2
Subjective itching
Change of subjective itching evaluated by the patient using VAS (0-10 score)
Measured: day 11 ± 2
Investigator global evaluation
Investigator global evaluation of performance using the 4-points scale: 3=very good; 2=good; 1= moderate; 0= poor
Measured: day 11 ± 2
Patient global evaluation
Patient global evaluation of performance using the 4-points scale: 3=very good; 2=good; 1= moderate; 0= poor
Measured: day 11 ± 2
Incidence of adverse events
The incidence of adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), and serious adverse device effects (SADEs) for the tested medical device will be collected by Investigators and analyzed comparing them with the incidence in standard population
Measured: day 11 ± 2
Investigator Global Safety Evaluation
Global safety evaluation performed by Investigator using the 4-points scale: 3=very good; 2=good; 1= moderate; 0= poor
Measured: day 11 ± 2
Patient Global Safety Evaluation
Global safety evaluation performed by the patient using the 4-points scale: 3=very good; 2=good; 1= moderate; 0= poor
Measured: day 11 ± 2
Incidence of Deficiencies
It will be analyzed and calculated comparing it with the already known deficiencies of the tested device
Measured: day 11 ± 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start29 Jul 2022
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rolf Kullgren AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Responsible party
- Sponsor
- Investigators
- Christiane Bünemann-Buschmann, Dr. med, Principal investigator, Frauenarztpraxis Berlin Gemeinschaftspraxis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241871
- Sponsor's protocol ID
- RKU/006920
- Other IDs
- DRKS00038289
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Post Market Clinical Follow up Investigation to Evaluate the Clinical Performance and Safety / Tolerability of Lactal Gel for Treatment of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT07241871
- Acronym / sponsor ID
- RKU/006920
- Conditions
- Bacterial Vaginosis
- Keywords
- Bacterial Vaginosis, medical device, lactic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rolf Kullgren ABIndustry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactal Gel | Experimental | Device: Lactal Gel (Class IIa medical device)Lactal Gel (Class IIa medical device): one tube daily administered as vaginal gel for 7 consecutive days, before bedtime |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Lactal Gel |
Primary outcome
Percent of Bacterial Vaginosis (BV)-free subjects
Time frame: day 11 ± 2 (final visit)
Percentage of BV-free subjects evaluated by Amsel criteria (at least of 3 of 4 criteria) and score
Amsel parameter total sum
Time frame: day 11 ± 2 (final visit)
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
9 secondary outcomes
Subjective vaginal odor
Time frame: day 11 ± 2
Subjective discomfort
Time frame: day 11 ± 2
Subjective itching
Time frame: day 11 ± 2
Investigator global evaluation
Time frame: day 11 ± 2
Patient global evaluation
Time frame: day 11 ± 2
Incidence of adverse events
Time frame: day 11 ± 2
Investigator Global Safety Evaluation
Time frame: day 11 ± 2
Patient Global Safety Evaluation
Time frame: day 11 ± 2
Incidence of Deficiencies
Time frame: day 11 ± 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane Bünemann-Buschmann, Dr. med principal investigator
Frauenarztpraxis Berlin Gemeinschaftspraxis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactal Gel (Class IIa medical device) in people with Bacterial Vaginosis, run by Rolf Kullgren AB at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Bacterial Vaginosis (BV)-free subjects (time frame: day 11 ± 2 (final visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.