Bacterial VaginosisNCT05211921
Single Arm Study of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
A study testing Multi-Gyn ActiGel Plus in people with Bacterial Vaginosis, run by Karo Pharma AB at 1 site in Poland.
Trial summary
Open, single arm trial that intends to confirm the safety and efficacy of Multi-Gyn ActiGel Plus for treatment of Bacterial Vaginosis. Adult women will be diagnosed by the gynaecologist based on the Amsel criteria at day 0. They will use the product for 7 days and will come to the practice at day 21. 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?
- Multi-Gyn ActiGel Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 7 Dec 2021to 11 May 2022
- 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
- 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
- Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amsel 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 11Show fewer
- 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.
About this study
Official title: A Single Arm Study to Confirm the Efficacy and Safety of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis.
Open, single arm trial that intends to confirm the safety and efficacy of Multi-Gyn ActiGel Plus for treatment of Bacterial Vaginosis. Adult women will be diagnosed by the gynaecologist based on the Amsel criteria at day 0. They will use the product for 7 days and will come to the practice at day 21. The primary endpoint is the clinical cure rate of Bacterial Vaginosis at 3 weeks after start of treatment.
- Conditions
- Bacterial Vaginosis
- Being tested
- Multi-Gyn ActiGel Plus
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Gyn ActiGel PlusDevice
vaginal gel
| Study group | Role | What they receive |
|---|---|---|
| Multi-Gyn ActiGel Plus | Other | vaginal gel Receives: Device: Multi-Gyn ActiGel Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is clinical cure rate of BV at 3 weeks after start of treatment (Visit 2).
Primary endpoint is to demonstrate a responder rate significantly higher than 30% in treatment of bacterial vaginosis at 3 weeks after start of treatment using a two tailed binomial test.
Measured: 3 weeks after start of treatment
Secondary outcomes (1)
Relief of vaginal symptoms related to BV at Visit 2
It is based on 0-10 point scale ( 0 is no improvement at all and 10 is the highest improvement)) . It is considered significant if the the score improvement is > 1.
Measured: 3 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start7 Dec 2021
- Primary completion11 May 2022
- Study completion11 May 2022
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
- Karo Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211921
- Sponsor's protocol ID
- 21E3559
- Status last verified
- Aug 2022
- First submitted
- 14 Jan 2022
- Last updated
- 18 Aug 2022
- 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 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Study to Confirm the Efficacy and Safety of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis.
- ClinicalTrials.gov ID
- NCT05211921
- Acronym / sponsor ID
- 21E3559
- Conditions
- Bacterial Vaginosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Karo Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 27 Jan 2022 (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.
Open, single arm trial that intends to confirm the safety and efficacy of Multi-Gyn ActiGel Plus for treatment of Bacterial Vaginosis. Adult women will be diagnosed by the gynaecologist based on the Amsel criteria at day 0. They will use the product for 7 days and will come to the practice at day 21. The primary endpoint is the clinical cure rate of Bacterial Vaginosis at 3 weeks after start of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-Gyn ActiGel Plus | Other | Device: Multi-Gyn ActiGel Plusvaginal 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 (11 listed)
- Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, vulvovaginal candidosis or aerobic vaginitis
- Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amsel 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 |
|---|---|---|
| Multi-Gyn ActiGel Plusvaginal gel | Device | Multi-Gyn ActiGel Plus |
Primary outcome
The primary endpoint is clinical cure rate of BV at 3 weeks after start of treatment (Visit 2).
Time frame: 3 weeks after start of treatment
Primary endpoint is to demonstrate a responder rate significantly higher than 30% in treatment of bacterial vaginosis at 3 weeks after start of treatment using a two tailed binomial test.
1 secondary outcome
Relief of vaginal symptoms related to BV at Visit 2
Time frame: 3 weeks after start of treatment
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 18 Aug 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Gyn ActiGel Plus in people with Bacterial Vaginosis, run by Karo Pharma AB at 1 site in Poland.
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 11 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 18 Aug 2022. 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 Poland. 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?
The primary endpoint is clinical cure rate of BV at 3 weeks after start of treatment (Visit 2). (time frame: 3 weeks after start of treatment). 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 18 Aug 2022.