Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

ConditionBacterial Vaginoses

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorBioClin BV

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

vaginal gel
Device
The placebo gel is a non-buffered gel. The active device is an acidic gel.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Active productOther 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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: 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

Time frame

3 weeks

Secondary outcomes

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.

Time frame

3 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioClin BV

Lead sponsor

Avania

Collaborator

Source ClinicalTrials.gov

Apply now