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

An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Bacterial Vaginosis

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).

Study Overview

• Status: Completed
• Conditions: Bacterial Vaginosis
• Intervention / Treatment: Device: pHyph generation I

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Helsingborg, Sweden
    • Stortorgets Gynekologmottagning
  • Lund, Sweden
    • Sophiakliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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:

  1. Thin, white, yellow, homogenous discharge
  2. Clue cells on microscopy (more than 20 percent of epithelial cells)
  3. pH of vaginal fluid above 4.5
  4. 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

Exclusion Criteria:

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
• Any medical condition that in the Investigator's judgments would make the patient unsuitable for inclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pHyph, Gedea Pessary; Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of BV.	Device: pHyph generation I; A vaginal tablet for the treatment of BV with administration every 48 hours.; Other Names: Gedea pessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Cure Rate	Defined as absence of all of the following 3 Amsel criteria: Thin, white, yellow, homogenous discharge; Clue cells on microscopy (more than 20% of epithelial cells); Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 1	Defined as absence of one of the following Amsel criteria: Thin, white, yellow, homogenous discharge; Clue cells on microscopy (more than 20% of epithelial cells); Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added	Day 7 compared to Day 0
Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 2	Defined as absence of one of the following Amsel criteria: Thin, white, yellow, homogenous discharge; Clue cells on microscopy (more than 20% of epithelial cells); Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution is added	Day 7 compared to Day 0
Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 3	Defined as absence of one of the following Amsel criteria: Thin, white, yellow, homogenous discharge; Clue cells on microscopy (more than 20% of epithelial cells); Release of fishy odour "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added	Day 7 compared to Day 0
Usability, Measured by Patient Questionnaire	General assessment of the treatment on a integer scale that ranges from 1 to 10. The lower end of the scale is indicated with the term "Not satisfied" and the higher end with the term "Very satisfied". Question asked: How do you generally regard the treatment?	Day 7
Proportion of Patients Having a Recurrence of the BV	Proportion of patients answering Yes to the question "Have the symptoms recurred?"	Up to Day 35

Collaborators and Investigators

• Sponsor: Gedea Biotech AB
• Investigators: Principal Investigator: Monika Cardell, MD, PhD, Kvinnokliniken, Region Skåne

Publications and helpful links

Helpful Links

• Sponsor webpage

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): October 22, 2019
• Study Completion (Actual): November 18, 2019

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: vulvovaginitis; vaginal disease; vaginitis; genital disease, female; vaginitis, bacterial
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Genital Diseases, Female; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginosis, Bacterial; Vaginal Diseases
• Other Study ID Numbers: QRS-CL2-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No