Studies
Finished
Clinical study 2: Bacterial vaginosis
Clinical study 1: Candida albicans
Stability Tests
In vitro data: Bacterial vaginosis
In vitro data: Bacterial vaginosis
Biological tests
Ongoing
Clinical trial 3: NEFERTITI Bacterial Vaginosis
NEFERTITI aims to recruit 150 adult women aged 18 or over with bacterial vaginosis diagnosed by Amsel’s* criteria and is due to start in late 2020. The primary objective is to investigate clinical performance of pHyph – in a smaller study reported earlier this year 82% of the women were clinically cured, defined as absence of all Amsel criteria, after 7 days. This corresponds to existing antibiotic-based treatment. After the first treatment period (day 0-7), patients that are cured will be randomized to preventive treatment, and given one tablet a week of pHyph or placebo, for four months. The follow up period will provide important data on pHyph´s impact on prevention of recurrent infections and the effect on the microbiome.
Upcoming
1. Bacterial vaginosis is diagnosed by Amsel-criteria. 2. Vaginal candidosis is diagnosed by wet smear with potassium hydroxide.