Single Arm Study of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

August 16, 2022 updated by: Karo Pharma AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdańsk, Poland
        • Eurofins Dermascan Poland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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
  • 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
  • Radiotherapy in the genitourinary system in the last 12 months
  • Use of antibiotics for any reason 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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Multi-Gyn ActiGel Plus
vaginal gel
Device: Multi-Gyn ActiGel Plus
vaginal gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint is clinical cure rate of BV at 3 weeks after start of treatment (Visit 2).
Time Frame: 3 weeks after start of treatment
Primary endpoint is to demonstrate a responder rate significantly higher than 30% in treatment of bacterial vaginosis at 3 weeks after start of treatment using a two tailed binomial test.
3 weeks after start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relief of vaginal symptoms related to BV at Visit 2
Time Frame: 3 weeks after start of treatment
It is based on 0-10 point scale ( 0 is no improvement at all and 10 is the highest improvement)) . It is considered significant if the the score improvement is > 1.
3 weeks after start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karo Pharma AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2021

Primary Completion (Actual)

May 11, 2022

Study Completion (Actual)

May 11, 2022

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21E3559

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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