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

NCT06123299 | Completed

• 1 other identifier: CL3-2
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 5

Brief Summary

This is a randomised, parallel group, partly blinded investigation to evaluate the clinical performance and safety of pHyph in adult women with bacterial vaginosis. Patients will be randomised to active treatment or no treatment (untreated controls) in a 1:1 ratio. The Investigators carrying out the gynaecological assessments will be blinded. Patients will not be blinded. The population of this investigation will consist of post-menarchal, pre-menopausal females 18 years or older seeking treatment for BV symptoms ("fishy smell", irritation and burning). Approximately 82-92 patients will be recruited and randomised. BV will be diagnosed according to Amsel's criteria, defined as having at least 3 of the 4 criteria. Active treatment (from the start of the investigation) will be compared to no treatment at day 7 after screening (primary endpoint). Clinical cure rate on Day 7 is defined as the absence of all of the following 3 Amsel criteria:

• Thin, white, yellow, homogeneous discharge.
• Clue cells on microscopy (\>20% of epithelial cells).
• Release of a "fishy odour", i.e., a positive "whiff test" when alkali (10% KOH solution) is added. Patients receiving rescue treatment before Day 7 will be considered as treatment failures. Patients in the "no treatment group" will receive pHyph as rescue treatment if they are not cured day 7. They will thereafter follow the same scheme as the patients starting with pHyph treatment. After the initial pHyph treatment, daily during 6 days, patients will continue with pHyph twice weekly until day 25 when an additional assessment will be performed. If the patients are cured, they will continue to receive pHyph as preventive treatment during 6 weeks and possible BV recurrences will be assessed.

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• Clinical cure rate on Day 7

  Defined as the absence of all of the following 3 Amsel criteria: * Thin, white, yellow, homogeneous discharge. * Clue cells on microscopy (\>20% of epithelial cells). * Release of a "fishy odour", i.e., a positive "whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added.

  7 days

Secondary Outcomes (20)

• Proportion of patients that do not have the symptom "fishy odour" on Days 1 to 7 after start of treatment, compared to Day 0, measured by using a patient questionnaire administered via mobile application.

  7 days

• Proportion of patients that do not have the symptom "fishy odour" on Day 7 after start of treatment, compared to Day 0, as assessed by the Investigator as part of the Amsel criteria.

  7 days

• Proportion of patients having a reduction in each of 3 BV symptoms scores on Days 1 to 7 after start of treatment, compared to Day 0, measured by using a patient questionnaire administered via mobile application.

  7 days

• Safety and local tolerability of pHyph for patients receiving daily treatment for 6 days, based on the reported treatment-emergent AEs up until Day 7 after start of treatment.

  7 days

• Clinical cure rate on Day 7 after start of treatment, defined as clinical cure according to secondary endpoint 1 and Nugent score <4, i.e., both criteria have to be fulfilled.

  7 days

Other Outcomes (3)

• Exploratory endpoints 1

  70 days

• Exploratory endpoints 2

  70 days

• Exploratory endpoints 3

  70 days

Study Arms (2)

pHyph treatment

ACTIVE COMPARATOR

Initial treatment with pHyph vaginal tablet once daily during 6 consecutive days

Device: pHyph

No treatment

NO INTERVENTION

No initial treament during the first 7 days of the study

Interventions

pHyph DEVICE

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, 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.

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 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.

Sponsors & Collaborators

• Gedea Biotech AB: lead

Study Sites (5)

CTC, Ebbe Park

Linköping, Sweden

Location

CTC GoCo

Mölndal, 451 53, Sweden

Location

CTC, Karolinska

Solna, Sweden

Location

Kvinnoforskningsenheten, KS Huddinge

Stockholm, Sweden

Location

CTC MTC

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 Officials

• Aino Fianu Jonasson, Ass. Prof.

  Karolinska Institute, Stockholm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 8, 2023
• Study Start: November 20, 2023
• Primary Completion: May 14, 2024
• Study Completion: September 4, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5)