Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

NCT04807842 | Recruiting

• 1 other identifier: MGAP BV 001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginoses

Outcome Measures

Primary Outcomes (1)

• 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

  3 weeks

Secondary Outcomes (1)

• Microbiological cure rate (based on Nugent score <4) at Visit 2

  3 weeks

Study Arms (2)

Active product

OTHER

Device: vaginal gel

Placebo

PLACEBO COMPARATOR

Device: vaginal gel

Interventions

vaginal gel DEVICE

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

Active product; Placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioClin BV: lead
• Avania: collaborator

Study Sites (1)

Praxis Dr. Peters

Hamburg, Germany

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Central Study Contacts

Diana Zeneli, MD

CONTACT

0031614706949; diana.pasho@karopharma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double blinded, randomized placebo controlled.

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 19, 2021
• Study Start: June 11, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)