In our ongoing study EpHect, the objective is to evaluate the effect of pHyph in treatment of vaginal fungal infection (Vulvo Vaginal Candiditis, VVC). The patients are treated with one tablet a day for 6 consecutive days. The study is conducted in collaboration with four gynecological clinics in Sweden. Read more about the study and have possibility to participate via this link (Swedish).
VVC is very common and as many as 75% of women globally will have an infection at least once in their lives. Many of those will experience recurrent infections. The cause of VVC is usually Candida albicans, a fungal species that is naturally present on skin and mucous membranes, but can transform into a pathogenic form as a response to an imbalance in its environment.
Bacterial vaginosis is a common condition, with a worldwide prevalence of 23-27%. The primary symptom of bacterial vaginosis is malodorous discharge, caused by an imbalance of bacteria normally present in the vagina.
In the NEFERTITI-2 study the effectiveness of pHyph in treating bacterial vaginosis is evaluated. Women experiencing bacterial vaginosis are invited to participate in the study and undergo treatment with pHyph vaginal tablets for six consecutive days. Patients who complete the treatment and achieve recovery will receive follow-up maintenance therapy for two months to prevent recurrence.
The study is being conducted at five clinics in Sweden. For more information about the study and to express your interest, please visit this web page
Clinical study 3: NEFERTITI, Bacterial vaginosis
Clinical study 2: Bacterial vaginosis
Clinical study 1: Vaginal Candidiasis
Stability tests show that the tablet is stable in its blister pack for at least 24 months. The product has a current shelf life of 36 months.
In vitro data: Bacterial vaginosis
pHyph provides an environment for the restoration of the natural vaginal flora by restoring the normal vaginal pH. The pH-lowering effect, favours the good, protective bacteria which outcompete the harmful, pathogenic bacteria. In addition, pHyph removes the biofilm, under which the harmful, pathogenic bacteria can hide and escape local treatments. Preclinical studies have verified that the active substances inhibits formation of biofilm and removes already established biofilm. Biofilm is commonly seen in bacterial vaginosis and is regarded as one of the main causes of recurrence of the infections. In preclinical studies, the active substances of pHyph has been shown to preferentially affect bacteria species associated with recurrent bacterial vaginosis (e.g. Gardnerella vaginalis), over beneficial Lactobacillus species, especially L.crispatus. By these means pHyph treats the bacterial vaginosis and reduces the risk of recurrence.
In vitro data: Candida fungus
Biological tests: Safety
1. Bacterial vaginosis is diagnosed by Amsel-criteria.
2. Vaginal candidosis is diagnosed by wet smear with potassium hydroxide.