Completed

A Single Arm Study to Confirm the Efficacy and Safety of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis.

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What is being tested

Multi-Gyn ActiGel Plus

Device
Who is being recruted

Urogenital Diseases+8

+ Genital Diseases

+ Bacterial Infections and Mycoses

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2021
See protocol details

Summary

Principal SponsorKaro Pharma AB
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 7, 2021

Actual date on which the first participant was enrolled.

Open, single arm trial that intends to confirm the safety and efficacy of Multi-Gyn ActiGel Plus for treatment of Bacterial Vaginosis. Adult women will be diagnosed by the gynaecologist based on the Amsel criteria at day 0. They will use the product for 7 days and will come to the practice at day 21. The primary endpoint is the clinical cure rate of Bacterial Vaginosis at 3 weeks after start of treatment.

Official TitleA Single Arm Study to Confirm the Efficacy and Safety of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis.
NCT05211921
Principal SponsorKaro Pharma AB
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesBacterial Infections and MycosesBacterial InfectionsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleInfectionsVaginal DiseasesVaginitisVaginosis, BacterialFemale Urogenital Diseases

Criteria

5 inclusion criteria required to participate
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
Show More Criteria
11 exclusion criteria prevent from participating
Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, vulvovaginal candidosis or aerobic vaginitis
Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amsel criteria (clue cells detection)
Current genital malignancies
Chemotherapy for any reason in last 6 months
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

vaginal gel

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Eurofins Dermascan Poland

Gdansk, PolandOpen Eurofins Dermascan Poland in Google Maps
CompletedOne Study Center