Back to resultsSingle Arm Study of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Primary Purpose
Bacterial Vaginosis
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Multi-Gyn ActiGel Plus
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Vaginosis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Eurofins Dermascan Poland
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Multi-Gyn ActiGel Plus
Arm Description
vaginal gel
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05211921
Brief Title
Single Arm Study of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Official Title
A Single Arm Study to Confirm the Efficacy and Safety of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
May 11, 2022 (Actual)
Study Completion Date
May 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karo Pharma AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. The primary endpoint is the clinical cure rate of Bacterial Vaginosis at 3 weeks after start of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multi-Gyn ActiGel Plus
Arm Type
Other
Arm Description
vaginal gel
Intervention Type
Device
Intervention Name(s)
Multi-Gyn ActiGel Plus
Intervention Description
vaginal gel
Primary Outcome Measure Information:
Title
The primary endpoint is clinical cure rate of BV at 3 weeks after start of treatment (Visit 2).
Description
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.
Time Frame
3 weeks after start of treatment
Secondary Outcome Measure Information:
Title
Relief of vaginal symptoms related to BV at Visit 2
Description
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.
Time Frame
3 weeks after start of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Facility Information:
Facility Name
Eurofins Dermascan Poland
City
Gdańsk
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Single Arm Study of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
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