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

• Willing and able to give written informed consent for participation in the clinical investigation, and to comply with all clinical investigation requirements.
• Adult, post-menarchal, pre-menopausal women aged 18 years or older.
• 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.
• Negative urine pregnancy test at screening.
• 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.
• 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).
• 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.

Exclusion criteria

• Patients with known or apparent signs of other infectious causes of vaginitis (e.g., vulvovaginal candidiasis, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening.
• History of or presence at screening (Day 0) of any other clinically significant disease or disorder, medical/surgical procedure, or trauma, which, in the opinion of the Investigator, may either put the patient at risk because of participation in the clinical investigation, or influence the results or the patient's ability to participate in the clinical investigation.
• Anticipated menstruation during the initial daily treatment period (Day 0 until Day 5).
• Patients who are pregnant or breastfeeding.
• Patients who are planning to conceive within the 70-77 days of the investigation.
• Patients who were treated for BV within the 14 days preceding screening.
• Patients who are currently receiving antibiotic therapy unrelated to BV or have received antibiotic therapy within the 14 days preceding screening.
• Patients who have used any pH-modifying vaginal products within the 14 days preceding screening.
• Patients who have received an investigational drug in a clinical trial within 30 days prior to screening.
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, to any of the product components.
• The Investigator considers the patient unlikely to comply with clinical investigation procedures, restrictions and requirements.