Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2021
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.
Epistemonikos ID: 1e814cd68902b186363698517eeb46820bc11874
First added on: May 08, 2024