An Open Single-armed Investigation to Evaluate the Safety of pHyph Following a Prolonged Treatment Duration in Adult Women With Bacterial Vaginosis

NCT07394777 | Completed

• 1 other identifier: BV-2025
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

• Presence of bacterial imbalance in the vagina
• Amount of different beneficial Lactobacillus bacteria
• Proportion of patients who recover from symptoms such as foul-smelling or abnormal discharge
• Change in vaginal pH and possible presence of vaginal yeast
• How easy and user-friendly the treatment is perceived according to patients' responses in an app Exploratory outcome measure To further evaluate vaginal microbiome data after different treatment lengths in patients with bacterial vaginosis (BV). 6\. Study design 32 women with BV are planning to be included in the study. The aim is to evaluate the safety after 12 days of treatment (days 0-5 and days 7-12) with pHyph in patients with BV. 7\. Study population The study will include women who have had their period but have not yet reached menopause, are 18 years of age or older and are seeking treatment, directly at a clinic or via advertising, for symptoms of BV, such as foul-smelling or abnormal discharge. The diagnosis of BV is made according to the Amsel criteria, defined as having at least three of the following criteria: thin whitish-yellow discharge, special cells visible under a microscope, a vaginal pH value higher than 4.5, and a distinct fishy odor when a basic substance is added (this symptom must be present). Women with signs of other vaginal infections will not be able to participate in the study. 8\. Interventions The study includes four clinic visits over a period of approximately 25 days. All participants receive active treatment with pHyph vaginal tablets, which are inserted vaginally at home in the evening with a CE marked applicator. Exact instructions are given at the first visit. At the four clinic visits, which are made on days 0, 7, 14 and 25, a gynecological examination is performed and samples are taken. Between visits, participants answer questions about BV symptoms and treatment via a mobile app.
• Visit 1 (Inclusion visit): with information, consent and pregnancy test. A gynecological examination and a sample for BV control are performed. The participant is given an applicator and tablets for 6 days of treatment to use at home every evening.
• Visit 2 (Day 7): A new gynecological examination and a sample for BV control. The participant is given an additional 6 days of tablets. A sample for BV control is taken at home on Day 10.
• Visit 3 (Day 14): A new gynecological examination and a sample for BV control and questions about the ease of use of the product.
• Visit 4 (Day 25): Follow-up visit with a new gynecological examination, sample for BV control, pregnancy test and questions about health and menstruation.

Conditions

Bacterial Vaginosis (BV)

Outcome Measures

Primary Outcomes (1)

• Safety based on reported adverse events from Visit 1 up until the end of Visit 4 and local tolerability based on signs of erythema, oedema and excoriation on the vaginal mucosa, according to a scoring scale (0-3), assessed at each visit.

  From enrollment until Day 25

Secondary Outcomes (14)

• Occurrence of vaginal dysbiosis.

  From enrollment until Day 25

• qPCR count of Lactobacillus crispatus

  From enrollment until Day 25

• qPCR count of beneficial Lactobacillus species (i.e., all Lactobacillus species except L. iners).

  From enrollment until Day 25

• qPCR count of all Lactobacillus species

  From enrollment until Day 25

• Clinical cure rate according to Amsel criteria

  From enrollment until Day 25

Study Arms (1)

pHyph treatment

EXPERIMENTAL

6 doses of pHyph will be administered Day 0-5 and another 6 doses will be administered Day 7-12

Device: pHyph

Interventions

pHyph DEVICE

pHyph is a vaginal tablet

pHyph treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, sex toys, lubricants or tampons, etc.) until Day 14.
• Willing to use condoms during any sexual intercourse with a male sexual partner until the pHyph treatment is complete (Day 14).
• 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.

You may not qualify if:

• 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 first treatment period (Day 0 until Day 7).
• Patients who are pregnant or breastfeeding.
• Patients who are planning to conceive within the 25 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.

Sponsors & Collaborators

• Gedea Biotech AB: lead
• CTC Clinical Trial Consultants AB: collaborator

Study Sites (2)

CTC Stockholm

Solna, Sweden

Location

CMedical

Uppsala, Sweden

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 6, 2026
• Study Start: January 15, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)