Bacterial Vaginoses
Conditions
Brief summary
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.
Interventions
DEVICEvaginal gel
The placebo gel is a non-buffered gel. The active device is an acidic gel.
Sponsors
Avania
BioClin BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
double blinded, randomized placebo controlled.
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 (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical cure rate of BV at 3 weeks after start of treatment (end-of treatment visit; Visit 2). | 3 weeks | Clinical cure is defined based on the following Amsel criteria: 1. presence of clue cells \<20% of the total epithelial cells on microscopic examination of the saline wet mount 2. resolution of the abnormal vaginal discharge, and 3. a negative whiff test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological cure rate (based on Nugent score <4) at Visit 2 | 3 weeks | The secondary objective of the study is to confirm the secondary efficacy of the product. |
Countries
Germany
Contacts
Primary ContactDiana Zeneli, MD
Outcome results
None listed