Bacterial VaginosisNCT03762083
Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis
A study testing pHyph generation I in people with Bacterial Vaginosis, run by Gedea Biotech AB at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- pHyph generation I
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesSweden
- Study dates
- 7 Jan 2019to 18 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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).
- Conditions
- Bacterial Vaginosis
- Being tested
- pHyph generation I
- Keywords
- vaginitis, vaginal disease, vulvovaginitis, genital disease, female, vaginitis, bacterial
- Medical subject headings
- Vaginosis, Bacterial, Vaginitis, Vaginal Diseases, Vulvovaginitis, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pHyph generation IDevice
Also called Gedea pessary
A vaginal tablet for the treatment of BV with administration every 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| pHyph, Gedea Pessary | Experimental | Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of BV. Receives: Device: pHyph generation I |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 7
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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?
Measured: Day 7
Proportion of Patients Having a Recurrence of the BV
Proportion of patients answering Yes to the question "Have the symptoms recurred?"
Measured: Up to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start7 Jan 2019
- Primary completion22 Oct 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gedea Biotech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monika Cardell, MD, PhD, Principal investigator, Kvinnokliniken, Region Skåne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762083
- Sponsor's protocol ID
- QRS-CL2-003
- Status last verified
- Jul 2025
- First submitted
- 30 Nov 2018
- Last updated
- 25 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT03762083
- Acronym / sponsor ID
- QRS-CL2-003
- Conditions
- Bacterial Vaginosis
- Keywords
- vaginitis, vaginal disease, vulvovaginitis, genital disease, female, vaginitis, bacterial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gedea Biotech ABIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Posted 25 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pHyph, Gedea Pessary | Experimental | Device: pHyph generation IClinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of BV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pHyph generation IAlso: Gedea pessaryA vaginal tablet for the treatment of BV with administration every 48 hours. | Device | pHyph, Gedea Pessary |
Primary outcome
Clinical Cure Rate
Time frame: 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
5 secondary outcomes
Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 1
Time frame: Day 7 compared to Day 0
Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 2
Time frame: Day 7 compared to Day 0
Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 3
Time frame: Day 7 compared to Day 0
Usability, Measured by Patient Questionnaire
Time frame: Day 7
Proportion of Patients Having a Recurrence of the BV
Time frame: Up to Day 35
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor webpageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Cardell, MD, PhD principal investigator
Kvinnokliniken, Region Skåne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pHyph generation I in people with Bacterial Vaginosis, run by Gedea Biotech AB at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure Rate (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.