NCT05211921

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Karo Pharma AB · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DEVICE	Multi-Gyn ActiGel Plus	vaginal gel

Timeline

• Start date: 2021-12-07
• Primary completion: 2022-05-11
• Completion: 2022-05-11
• First posted: 2022-01-27
• Last updated: 2022-08-18

Locations

1 site across 1 country: Poland