Bacterial Vaginosis
Conditions
Keywords
vaginitis, vaginal disease, vulvovaginitis, genital disease, female, vaginitis, bacterial
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).
Interventions
DEVICEpHyph generation I
A vaginal tablet for the treatment of BV with administration every 48 hours.
Sponsors
Gedea Biotech AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure Rate | Day 7 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 1 | Day 7 compared to Day 0 | 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 |
| Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 2 | Day 7 compared to Day 0 | 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 |
| Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 3 | Day 7 compared to Day 0 | 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 |
| Usability, Measured by Patient Questionnaire | Day 7 | 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? |
| Proportion of Patients Having a Recurrence of the BV | Up to Day 35 | Proportion of patients answering Yes to the question Have the symptoms recurred? |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| pHyph, Gedea Pessary Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of BV.
pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of BV. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | pHyph, Gedea Pessary | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 24 Participants | — |
| Age, Continuous | 33.1 years STANDARD_DEVIATION 8.8 | — |
| Experience any bacterial vaginosis (BV) infection during the last 12 months No | 8 Participants | — |
| Experience any bacterial vaginosis (BV) infection during the last 12 months Yes | 16 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Sweden | 24 Participants | — |
| Sex: Female, Male Female | 24 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 11 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
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
Population: Number of patients included in analysis = 22.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| pHyph, Gedea Pessary | Clinical Cure Rate | 18 Participants |
Comparison: It was assumed that the true cure rate was equal to 70%, therefore 22 patients were needed to obtain 90% chance (90% power) to show that the one-sided 95% confidence interval (CI) for the observed cure rate was above 40%.~Hypotheses for the primary clinical performance endpoint:~* Null hypothesis: Clinical cure rate is less than or equal to 40%.~* Alternative hypothesis (one-sided): Clinical cure rate is above 40%.
Secondary
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
Population: Statistical analysis of proportion of patients being negative for Amsel criterion 1 (discharge) on Day 7 compared to Day 0. Number of patients included in analysis =21.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| pHyph, Gedea Pessary | Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 1 | 18 Participants |
95% CI: [63.7, 97]
Secondary
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
Population: Statistical analysis of proportion of patients being negative for Amsel criterion 2 (clue cells) on Day 7 compared to Day 0. Number of patients included in analysis = 20.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| pHyph, Gedea Pessary | Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 2 | 18 Participants |
95% CI: [68.3, 98.8]
Secondary
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
Population: Statistical analysis of proportion of patients being negative for Amsel criterion 3 (fishy odour) on Day 7 compared to Day 0. Number of participants included in the analysis = 22.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| pHyph, Gedea Pessary | Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 3 | 19 Participants |
95% CI: [65.1, 97.1]
Secondary
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
Population: The Full analysis set population contained 24 patients.The sub-set of the Full analysis set including patients not receiving prolonged treatment contained 18 patients. Of these, 18 patients were included in this analysis of recurrence at Day 14 and 16 patients were included in the analysis of recurrence at Day 35.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| pHyph, Gedea Pessary | Proportion of Patients Having a Recurrence of the BV | Day 14 | 1 Participants |
| pHyph, Gedea Pessary | Proportion of Patients Having a Recurrence of the BV | Day 35 | 0 Participants |
95% CI: [0.1, 27.3]
95% CI: [0, 20.6]
Secondary
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
Population: The Full analysis set population contained 24 patients. 2 patients were not included in this analysis due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| pHyph, Gedea Pessary | Usability, Measured by Patient Questionnaire | 7.1 Integer scale (1-10) | Standard Deviation 2.3 |