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

Study Overview
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Brief Summary
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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 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).

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

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Device: pHyph, Gedea pessary


Participation Criteria
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Eligibility Criteria
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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: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pHyph, Gedea Pessary<br>Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of BV. | Device: pHyph, Gedea pessary<br>* pHyph is a vaginal tablet for the treatment of BV.<br>|

What is the study measuring?
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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 | Defined as absence 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 | 
| Usability, measured by patient questionnaire | General assessment of the treatment [1-10, where 10 is very pleased and 1 is very unpleased] | 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 42 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginitis, vaginal disease, vulvovaginitis, genital disease, female, vaginitis, bacterial