Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

Study Overview
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Brief Summary
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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.

Official Title
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A Double-blind, Randomized, Placebo-controlled Study to Confirm the Efficacy and Safety of Multi- Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

Conditions
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Bacterial Vaginoses

Intervention / Treatment
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* Device: vaginal gel


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 (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 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

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blinded, randomized placebo controlled.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Active product<br> | Device: vaginal gel<br>* The placebo gel is a non-buffered gel. The active device is an acidic gel.<br>|
| Placebo Comparator: Placebo<br> | Device: vaginal gel<br>* The placebo gel is a non-buffered gel. The active device is an acidic gel.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 weeks |