Bacterial VaginosesNCT04807842
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
A study testing vaginal gel in people with Bacterial Vaginoses, run by BioClin BV at 1 site in Germany.
Trial summary
This is a randomized, double-blind, placebo-controlled clinical investigation. The objective of the study is to confirm the efficacy of Multi-Gyn ActiGel Plus to treat BV as compared to a placebo control. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Vaginoses
- What is being tested?
- vaginal gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jun 2021to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women diagnosed with BV (3 out of 4 Amsel criteria positive, with at least presence of clue cells (>20%))
- Women of childbearing potential
- Aged >18 years
- Signed written informed consent form
- Willing to comply to the follow-up schedule
Who cannot join
- Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, vulvovaginal candidosis or aerobic vaginitis (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis)
- Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amstel criteria (clue cells detection)
- Current genital malignancies
- Chemotherapy for any reason in last 6 months
- Radiotherapy in the genitourinary system in the last 12 months
- Use of antibiotics for any reason in the last 14 days
Show all 12Show fewer
- Use of intravaginal devices during the investigation or in the last 14 days
- Pregnancy or currently attempting to conceive
- Lactation
- Use of other treatment for vaginal conditions during the course of the clinical investigation
- Known allergies to ingredients of the product
- Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Praxis Dr. Peters
Hamburg
Klaus H Peters, Dr.med
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study to Confirm the Efficacy and Safety of Multi- Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
This is a randomized, double-blind, placebo-controlled clinical investigation. The objective of the study is to confirm the efficacy of Multi-Gyn ActiGel Plus to treat BV as compared to a placebo control.
Treatment arm 1: Multi-Gyn ActiGel Plus Treatment arm 2: placebo gel Both the Multi-Gyn ActiGel Plus and the placebo will be applied twice a day for 7 consecutive days. Visit 2 will be performed at 3 weeks after start of treatment A phone call will take place, at 5 weeks after start of treatment for subject with clinical cure at Visit 2. The total duration per subject is estimated 5 weeks and the total study duration is 13 months. Sample size is 100 subjects per treatment arm.
- Conditions
- Bacterial Vaginoses
- Being tested
- vaginal gel
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal gelDevice
The placebo gel is a non-buffered gel. The active device is an acidic gel.
| Study group | Role | What they receive |
|---|---|---|
| Active product | Other | Not described Receives: Device: vaginal gel |
| Placebo | Placebo comparator | Not described Receives: Device: vaginal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate of BV at 3 weeks after start of treatment (end-of treatment visit; Visit 2).
Clinical cure is defined based on the following Amsel criteria:
- presence of clue cells <20% of the total epithelial cells on microscopic examination of the saline wet mount
- resolution of the abnormal vaginal discharge, and
- a negative whiff test
Measured: 3 weeks
Secondary outcomes (1)
Microbiological cure rate (based on Nugent score <4) at Visit 2
The secondary objective of the study is to confirm the secondary efficacy of the product.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start11 Jun 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blinded, randomized placebo controlled.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioClin BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807842
- Sponsor's protocol ID
- MGAP BV 001
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2021
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study to Confirm the Efficacy and Safety of Multi- Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT04807842
- Acronym / sponsor ID
- MGAP BV 001
- Conditions
- Bacterial Vaginoses
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- BioClin BVIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Mar 2021 (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.
This is a randomized, double-blind, placebo-controlled clinical investigation. The objective of the study is to confirm the efficacy of Multi-Gyn ActiGel Plus to treat BV as compared to a placebo control.
Treatment arm 1: Multi-Gyn ActiGel Plus Treatment arm 2: placebo gel Both the Multi-Gyn ActiGel Plus and the placebo will be applied twice a day for 7 consecutive days. Visit 2 will be performed at 3 weeks after start of treatment A phone call will take place, at 5 weeks after start of treatment for subject with clinical cure at Visit 2. The total duration per subject is estimated 5 weeks and the total study duration is 13 months. Sample size is 100 subjects per treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blinded, randomized placebo controlled.
| Arm | Type | Receives |
|---|---|---|
| Active product | Other | Device: vaginal gel |
| Placebo | Placebo comparator | Device: vaginal gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women diagnosed with BV (3 out of 4 Amsel criteria positive, with at least presence of clue cells (>20%))
- Women of childbearing potential
- Aged >18 years
- Signed written informed consent form
- Willing to comply to the follow-up schedule
Key exclusion criteria (12 listed)
- Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, vulvovaginal candidosis or aerobic vaginitis (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis)
- Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amstel criteria (clue cells detection)
- Current genital malignancies
- Chemotherapy for any reason in last 6 months
- Radiotherapy in the genitourinary system in the last 12 months
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 |
|---|---|---|
| vaginal gelThe placebo gel is a non-buffered gel. The active device is an acidic gel. | Device | Active product, Placebo |
Primary outcome
Clinical cure rate of BV at 3 weeks after start of treatment (end-of treatment visit; Visit 2).
Time frame: 3 weeks
Clinical cure is defined based on the following Amsel criteria: 1. presence of clue cells <20% of the total epithelial cells on microscopic examination of the saline wet mount 2. resolution of the abnormal vaginal discharge, and 3. a negative whiff test
1 secondary outcome
Microbiological cure rate (based on Nugent score <4) at Visit 2
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal gel in people with Bacterial Vaginoses, run by BioClin BV 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Zeneli, MD (0031614706949, diana.pasho@karopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure rate of BV at 3 weeks after start of treatment (end-of treatment visit; Visit 2). (time frame: 3 weeks). 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 2 Oct 2026.