An interventional study of Multi-Gyn ActiGel Plus in Bacterial Vaginosis, sponsored by Karo Pharma AB. Completed at 1 site in Poland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-18.
Sponsored by Karo Pharma AB · Not applicable, Interventional, and Treatment
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.
228 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.
This study's enrollment of 50 is below the median of 100 across 194 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Karo Pharma AB is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
vaginal gel
Device: Multi-Gyn ActiGel Plus
vaginal gel
The primary endpoint is clinical cure rate of BV at 3 weeks after start of treatment (Visit 2).
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.
Time frame: 3 weeks after start of treatment
Relief of vaginal symptoms related to BV at Visit 2
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.
Time frame: 3 weeks after start of treatment
Plan to share: No
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Karo Pharma AB