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New vaginal tablet shows promise in taming recurrent bacterial vaginosis

NCT ID NCT07394777

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

32 people

The number who actually took part.

Started

Jan 2026

Finished

Apr 2026

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • CMedical

    Uppsala, Sweden

  • CTC Stockholm

    Solna, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.