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RECRUITING
NCT04807842
NA

Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

Sponsor: BioClin BV

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2021-06-11

Completion Date

2026-12-01

Last Updated

2025-09-29

Healthy Volunteers

No

Interventions

DEVICE

vaginal gel

The placebo gel is a non-buffered gel. The active device is an acidic gel.

Locations (1)

Praxis Dr. Peters

Hamburg, Germany