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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
A vaginal tablet for the treatment of BV with administration every 48 hours.
Stortorgets Gynekologmottagning
Helsingborg, Sweden
Sophiakliniken
Lund, Sweden
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
Time frame: Day 7
Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 1
Defined as absence of one of the following 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
Time frame: 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: 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
Time frame: 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: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odour "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added
Time frame: 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?
Time frame: Day 7
Proportion of Patients Having a Recurrence of the BV
Proportion of patients answering Yes to the question "Have the symptoms recurred?"
Time frame: Up to Day 35
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