Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pHyph, Gedea Pessary | Experimental | Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of BV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pHyph generation I | Device | A vaginal tablet for the treatment of BV with administration every 48 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure Rate | Defined as absence of all of the following 3 Amsel criteria:
| Day 7 |
| 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:
| Day 7 compared to Day 0 |
Not provided
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Monika Cardell, MD, PhD | Kvinnokliniken, Region Skåne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stortorgets Gynekologmottagning | Helsingborg | Sweden | ||||
| Sophiakliniken |
Not provided
| Label | URL |
|---|---|
| Sponsor webpage | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | pHyph, Gedea Pessary | Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of bacterial vaginosis (BV). pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of BV. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 24 participants were enrolled, and all 24 participants received study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Cure Rate | Defined as absence of all of the following 3 Amsel criteria:
| Number of patients included in analysis = 22. | Posted | Count of Participants | Participants | Day 7 |
|
Up to day 42.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | pHyph, Gedea Pessary | Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of bacterial vaginosis (BV). pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of BV. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annette Säfholm, CEO | Gedea Biotech AB | 0046 708 91 86 81 | annette.safholm@gedeabiotech.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 27, 2019 | Jul 8, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 5, 2019 | Jul 8, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D014848 | Vulvovaginitis |
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 2 | Defined as absence of one of the following Amsel criteria:
| 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:
| 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 |
| Lund |
| Sweden |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Experience any bacterial vaginosis (BV) infection during the last 12 months | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 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:
| 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. | Posted | Count of Participants | Participants | Day 7 compared to Day 0 |
|
|
|
|
| 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:
| 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. | Posted | Count of Participants | Participants | Day 7 compared to Day 0 |
|
|
|
|
| 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:
| 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. | Posted | Count of Participants | Participants | Day 7 compared to Day 0 |
|
|
|
|
| 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? | The Full analysis set population contained 24 patients. 2 patients were not included in this analysis due to missing data. | Posted | Mean | Standard Deviation | Integer scale (1-10) | Day 7 |
|
|
|
| Secondary | Proportion of Patients Having a Recurrence of the BV | Proportion of patients answering Yes to the question "Have the symptoms recurred?" | 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. | Posted | Count of Participants | Participants | Up to Day 35 |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 11 |
| 24 |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (22.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
|
| Recurrence rate Day 35 |
| 0 |
| 2-Sided |
| 95 |
| 0 |
| 20.6 |
| Other |
Results are based on the exact binomial distribution (Clopper-Pearson). |