Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

Not Applicable

Recruiting

• Conditions: Bacterial Vaginoses
• Interventions: Device: vaginal gel

• Registration Number: NCT04807842
• Lead Sponsor: BioClin BV

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-19
• Study Start: 2021-06-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active product	vaginal gel	-
Placebo	vaginal gel	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Praxis Dr. Peters; 🇩🇪 Hamburg, Germany