Single Arm Study of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

Study Overview
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Brief Summary
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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.

Official Title
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A Single Arm Study to Confirm the Efficacy and Safety of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis.

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Device: Multi-Gyn ActiGel Plus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Multi-Gyn ActiGel Plus<br>vaginal gel | Device: Multi-Gyn ActiGel Plus<br>* vaginal gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 weeks after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 weeks after start of treatment |