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

Not Applicable

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Device: Multi-Gyn ActiGel Plus

• Registration Number: NCT05211921
• Lead Sponsor: Karo Pharma AB

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-07
• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-27
• Primary Completion: 2022-05-11
• Study Completion: 2022-05-11
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multi-Gyn ActiGel Plus	Multi-Gyn ActiGel Plus	vaginal gel

Primary Outcome Measures

Name	Time	Method
The primary endpoint is clinical cure rate of BV at 3 weeks after start of treatment (Visit 2).	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.

Secondary Outcome Measures

Name	Time	Method
Relief of vaginal symptoms related to BV at Visit 2	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.

Trial Locations

Locations (1)

Eurofins Dermascan Poland; 🇵🇱 Gdańsk, Poland