NCT04807842

Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

A Double-blind, Randomized, Placebo-controlled Study to Confirm the Efficacy and Safety of Multi- Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: BioClin BV · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	vaginal gel	The placebo gel is a non-buffered gel. The active device is an acidic gel.

Timeline

• Start date: 2021-06-11
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2021-03-19
• Last updated: 2025-09-29

Locations

1 site across 1 country: Germany