Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis

NCT03762083 | Completed Results

• 1 other identifier: QRS-CL2-003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with confirmed bacterial vaginosis (BV) according to fulfillment of at least 3 of the 4 Amsel criteria. On Day 0, patients will have gynecological examination, vaginal samples taken, and will receive the investigational product to be self-administered. Patients will be examined after 7 days with respect to 3 Amsel criteria (the criterion: "pH of vaginal fluid above 4.5" is only included at study inclusion for diagnosis), and if not cured, will receive prolonged treatment for one additional week. Patients will be followed-up by telephone up to 29 days after last treatment. Vaginal samples will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be used for assessing BV symptoms, usability, and adverse events (AEs).

Conditions

Bacterial Vaginosis

Keywords

vaginitis; vaginal disease; vulvovaginitis; genital disease, female; vaginitis, bacterial

Outcome Measures

Primary Outcomes (1)

• Clinical Cure Rate

  Defined as absence of all of the following 3 Amsel criteria: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added

  Day 7

Secondary Outcomes (5)

• Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 1

  Day 7 compared to Day 0

• Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 2

  Day 7 compared to Day 0

• Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 3

  Day 7 compared to Day 0

• Usability, Measured by Patient Questionnaire

  Day 7

• Proportion of Patients Having a Recurrence of the BV

  Up to Day 35

Study Arms (1)

pHyph, Gedea Pessary

EXPERIMENTAL

Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of BV.

Device: pHyph generation I

Interventions

pHyph generation I DEVICE

A vaginal tablet for the treatment of BV with administration every 48 hours.

Also known as: Gedea pessary

pHyph, Gedea Pessary

Eligibility Criteria

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

You may qualify if:

• 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, homogenous discharge
• Clue cells on microscopy (more than 20 percent of epithelial cells)
• pH of vaginal fluid above 4.5
• Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added
• Having decisional capacity and providing written informed consent
• Negative urine pregnancy test at screening
• Refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period
• Refrain from sexual intercourse or use a condom until Day 7
• Signed informed consent and willing and able to comply with all study requirements

You may not qualify if:

• Patients with known or apparent signs of other infectious causes of BV (vulvovaginal candidiasis, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening
• Anticipated menstruation during the treatment period (Day 0 till Day 7)
• Patients who are pregnant or breastfeeding
• Patients who were treated for BV within the past 14 days
• Patients who are currently receiving antibiotic therapy unrelated to BV or have received antibiotic therapy within the past 14 days
• Patients who have used pH-modifying vaginal products within the last 14 days
• Patients who have received an investigational drug in a clinical investigation within 30 days prior to screening
• Known/previous allergy or hypersensitivity to any product constituent

Sponsors & Collaborators

• Gedea Biotech AB: lead

Study Sites (2)

Stortorgets Gynekologmottagning

Helsingborg, Sweden

Location

Sophiakliniken

Lund, Sweden

Location

Related Links

• Sponsor webpage

MeSH Terms

Conditions

Vaginosis, Bacterial; Vaginitis; Vaginal Diseases; Vulvovaginitis; Genital Diseases, Female

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvitis; Vulvar Diseases

Results Point of Contact

• Title: Annette Säfholm, CEO
• Organization: Gedea Biotech AB

annette.safholm@gedeabiotech.com

0046 708 91 86 81

Study Officials

• Monika Cardell, MD, PhD

  Kvinnokliniken, Region Skåne

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: November 30, 2018
• First Posted: December 3, 2018
• Study Start: January 7, 2019
• Primary Completion: October 22, 2019
• Study Completion: November 18, 2019
• Last Updated: July 25, 2025
• Results First Posted: July 25, 2025

Record last verified: 2025-07

Locations

SE (2)