Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bacterial Vaginoses
• Intervention / Treatment: Device: vaginal gel

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diana Zeneli, MD; Phone Number: 0031614706949; Email: diana.pasho@karopharma.com

Study Locations

• Germany
  • Hamburg, Germany
    • Recruiting
    • Praxis Dr. Peters
    • Contact: Klaus H Peters, Dr.med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: BioClin BV
• Collaborators: Avania

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginal Diseases; Vaginosis, Bacterial
• Other Study ID Numbers: MGAP BV 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No