A Randomised, Partly-blinded Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Bacterial Vaginosis Compared With an Untreated Control Group

Inclusion Criteria

• •1. Willing and able to give written informed consent for participation in the clinical investigation, and to comply with all clinical investigation requirements.
• •2. Adult, post-menarchal, pre-menopausal women aged 18 years or older.
• •3. Diagnosis of BV according to Amsel's criteria, defined as having at least 3 of the 4 following criteria:
• •* Thin, white, yellow, homogeneous discharge.
• •* Clue cells on microscopy (\>20% of epithelial cells).
• •* pH of vaginal fluid \>4.5.
• •* Release of "fishy odour", i.e., a positive "whiff test" when alkali (10% KOH solution) is added. This symptom must be present.
• •4. Negative urine pregnancy test at screening.
• •5. Willing to refrain from using any intravaginal products (e.g., contraceptive creams, gels, foams, sponges, lubricants or tampons, etc.) until Day 7 and the following 24 hours after each pHyph administration during weekly treatment.
• •6. Willing to use condoms during any sexual intercourse with a male sexual partner until the initial pHyph treatment is completes. For patients starting with pHyph on Day 0, this means from Visit 1 (Day 0) until Visit 2 (Day 7). For patients that do not receive any treatment between Day 0 and Day 7, this means from Visit 1 (Day 0), and if they receive pHyph from Day 7, until their Visit 2 (Day 14).
• •7. Willing to use a method of contraception, e.g., condoms, hormonal contraception (oral, injectable, implantable, intravaginal, or transdermal), intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), during any sexual intercourse that might result in pregnancy from Visit 2 (Day 7 or 14) until Visit 4 (70-77 days) to prevent pregnancy.