New vaginal tablet shows promise in taming recurrent bacterial vaginosis
NCT ID NCT07394777
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the safety of using pHyph, a vaginal tablet that naturally restores acidity, for 12 days in 32 adult women with bacterial vaginosis (BV). BV is a common infection causing unpleasant discharge and odor, and often returns after antibiotic treatment. The goal was to see if a longer treatment course is safe and well-tolerated, while also checking if it helps restore healthy vaginal bacteria and relieve symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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32 people
The number who actually took part.
- Started
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Jan 2026
- Finished
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Apr 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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, sex toys, lubricants or tampons, etc.) until Day 14. 6. Willing to use condoms during any sexual intercourse with a male sexual partner until the pHyph treatment is complete (Day 14). 7. Willing to use a method of contraception, e.g., condoms, hormonal contraception (oral, injectable, implantable, intravaginal, or transdermal), IUD (if a copper IUD is used, it must be combined with a condom) or intrauterine hormone-releasing system (IUS), during any sexual intercourse that might result in pregnancy from Visit 1 (Day 0) until Visit 4 (Day 25) to prevent pregnancy. Exclusion Criteria: 1. 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. 2. 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. 3. Anticipated menstruation during the first treatment period (Day 0 until Day 7). 4. Patients who are pregnant or breastfeeding. 5. Patients who are planning to conceive within the 25 days of the investigation. 6. Patients who were treated for BV within the 14 days preceding screening. 7. Patients who are currently receiving antibiotic therapy unrelated to BV or have received antibiotic therapy within the 14 days preceding screening. 8. Patients who have used any pH-modifying vaginal products within the 14 days preceding screening. 9. Patients who have received an investigational drug in a clinical trial within 30 days prior to screening. 10. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, to any of the product components. 11. The Investigator considers the patient unlikely to comply with clinical investigation procedures, restrictions and requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CMedical
Uppsala, Sweden
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CTC Stockholm
Solna, Sweden
More trials for these conditions
Other studies related to the condition(s) this trial covers.