Bacterial Vaginosis
Conditions
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.
Interventions
DEVICEMulti-Gyn ActiGel Plus
vaginal gel
Sponsors
Karo Pharma AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint is clinical cure rate of BV at 3 weeks after start of treatment (Visit 2). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relief of vaginal symptoms related to BV at Visit 2 | 3 weeks after start of treatment | 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. |
Countries
Poland
Outcome results
None listed