Bacterial VaginosisNefertitiNCT04640922
Clinical Performance and Safety of the Gedea Pessary in Adult Women With Bacterial Vaginosis
A study testing Gedea Pessary pHyph in people with Bacterial Vaginosis, run by Gedea Biotech AB at 5 sites in 2 countries.
Trial summary
This is a randomised, double-blind placebo-controlled multi-centre study to evaluate clinical performance, safety and local tolerability of initial and preventive treatment with Gedea Pessary in adult women with confirmed BV. 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?
- Gedea Pessary pHyph
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 27 Jan 2020to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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.) until Day 7 and the following 24 hours after each treatment during weekly treatment.
- Refrain from sexual intercourse or use a condom until Day 7.
- Willing to use contraception (if heterosexual) for 128 days.
- 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 vaginitis (e.g.
- 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 5).
- Patients who are pregnant or breastfeeding.
- Patients who are planning to conceive within the 128 days study duration.
- Patients who were treated for BV within the past 14 days.
Show all 11Show fewer
- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United Kingdom3 sites
Derbyshire Community Health Services NHS Foundation Trust
Derby
Northamptonshire Healthcare NHS Foundation Trust (NHFT)
Northampton
Nottingham University Hospitals NHS Trust
Nottingham
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate Clinical Performance and Safety of the Gedea Pessary in Adult Women With Bacterial Vaginosis
This is a randomised, double-blind placebo-controlled multi-centre study to evaluate clinical performance, safety and local tolerability of initial and preventive treatment with Gedea Pessary in adult women with confirmed BV.
The study population will consist of post-menarchal, pre-menopausal females 18 years or older seeking for BV symptoms (fishy smell, irritation and burning).
Read more
Patients will be recruited at study sites' gynaecological and sexual health clinics and a total of 150 patients are planned to be randomised in the study.
On Day 0, patients will have gynaecological examination, vaginal samples taken, and will be randomised in a 4:1 relation to receive treatment with 6 doses of the Gedea Pessary or a vehicle control (placebo) to be self-administered daily (Days 0 to 5). Patients will be re examined at Day 7 (+2 days) for clinical cure rate.
Patients that are clinically cured at Day 7 will continue to the second part of the study and will be randomised in a 1:1 relation to either Gedea Pessary or placebo treatment, to be self administered once a week for a duration of 126 days.
Patients not clinically cured at Day 7 will be offered rescue treatment (metronidazole) for 7 days. They will return at Day 14 for clinical assessment and sampling for microbiome and mycobiome analysis, and if cured they will be assessed for recurrence up to Day 128. Patients that are not cured at Day 14 will be discontinued from the study.
Patients that are clinically cured at Day 7 and continuing in Part 2 will be followed up until confirmed recurrence or Day 128 if no recurrence. Vaginal samples will be taken by self-swab on Days 35, 63 and 91, a visit to the clinic will be performed at Day 63 and telephone follow up will be done at Days 35 and 91. Vaginal samples will also be taken at the visit on the Day of potential recurrence and/or at Day 128 if no recurrence.
Vaginal samples will be used for confirming the diagnosis (Nugent score on Day 0 and Day 7) and sequencing analysis of the vaginal microbiome and mycobiome (Days 0, 7, 35, 63, 91 and Day of confirmed recurrence or Day 128 if no recurrence).
Patient follow-up as regards to patient questionnaire/usability, AEs and BV recurrence notification will be handled with a mobile phone application. In case of a suspected BV recurrence, the patient should return to the clinic for confirmation of BV diagnosis.
- Conditions
- Bacterial Vaginosis
- Being tested
- Gedea Pessary pHyph, Placebo
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gedea Pessary pHyphDevice
Vaginal tablet
PlaceboDevice
Vaginal tablet
| Study group | Role | What they receive |
|---|---|---|
| Gedea Pessary | Active comparator | pHyph, vaginal tablet, daily in Part 1 and once weekly in Part 2 Receives: Device: Gedea Pessary pHyph |
| Placebo | Placebo comparator | placebo, vaginal tablet, daily in Part 1 and once weekly in Part 2 Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate on Day 7
- 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 odour "i.e. a positive whiff test" when alkali (10% KOH solution) is added.
Measured: Day 7
Secondary outcomes (3)
Safety and local tolerability of Gedea Pessary - based on reported treatment-emergent AEs up until Day 7.
Part 1
Measured: Day 7
Clinical cure rate on Day 7, defined as clinical cure according to primary endpoint and Nugent score <4, i.e. both criteria have to be fulfilled.
Part 1
Measured: Day 7
Difference between Day 7 and Days 35, 63, 91, 128 and/or Day of possible recurrence confirmation (assessed by Amsel criteria), respectively, in the occurrence of anaerobic vaginal dysbiosis as assessed by analysis of the vaginal microbiome.
Part 2
Measured: Day 35, 63, 91, and 128, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start27 Jan 2020
- Primary completion31 Jan 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, double-blind placebo-controlled multi-centre study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gedea Biotech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640922
- Sponsor's protocol ID
- QRS-CL3-003
- Other IDs
- CIV-GB-20-09-034813
- Acronym
- Nefertiti
- Status last verified
- Aug 2022
- First submitted
- 13 Nov 2020
- Last updated
- 18 Aug 2022
- Results posted
- No
- 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 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Study to Evaluate Clinical Performance and Safety of the Gedea Pessary in Adult Women With Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT04640922
- Acronym / sponsor ID
- Nefertiti / QRS-CL3-003
- Conditions
- Bacterial Vaginosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Gedea Biotech ABIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomised, double-blind placebo-controlled multi-centre study to evaluate clinical performance, safety and local tolerability of initial and preventive treatment with Gedea Pessary in adult women with confirmed BV.
The study population will consist of post-menarchal, pre-menopausal females 18 years or older seeking for BV symptoms (fishy smell, irritation and burning).
Patients will be recruited at study sites' gynaecological and sexual health clinics and a total of 150 patients are planned to be randomised in the study.
On Day 0, patients will have gynaecological examination, vaginal samples taken, and will be randomised in a 4:1 relation to receive treatment with 6 doses of the Gedea Pessary or a vehicle control (placebo) to be self-administered daily (Days 0 to 5). Patients will be re examined at Day 7 (+2 days) for clinical cure rate.
Patients that are clinically cured at Day 7 will continue to the second part of the study and will be randomised in a 1:1 relation to either Gedea Pessary or placebo treatment, to be self administered once a week for a duration of 126 days.
Patients not clinically cured at Day 7 will be offered rescue treatment (metronidazole) for 7 days. They will return at Day 14 for clinical assessment and sampling for microbiome and mycobiome analysis, and if cured they will be assessed for recurrence up to Day 128. Patients that are not cured at Day 14 will be discontinued from the study.
Patients that are clinically cured at Day 7 and continuing in Part 2 will be followed up until confirmed recurrence or Day 128 if no recurrence. Vaginal samples will be taken by self-swab on Days 35, 63 and 91, a visit to the clinic will be performed at Day 63 and telephone follow up will be done at Days 35 and 91. Vaginal samples will also be taken at the visit on the Day of potential recurrence and/or at Day 128 if no recurrence.
Vaginal samples will be used for confirming the diagnosis (Nugent score on Day 0 and Day 7) and sequencing analysis of the vaginal microbiome and mycobiome (Days 0, 7, 35, 63, 91 and Day of confirmed recurrence or Day 128 if no recurrence).
Patient follow-up as regards to patient questionnaire/usability, AEs and BV recurrence notification will be handled with a mobile phone application. In case of a suspected BV recurrence, the patient should return to the clinic for confirmation of BV diagnosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, double-blind placebo-controlled multi-centre study
| Arm | Type | Receives |
|---|---|---|
| Gedea Pessary | Active comparator | Device: Gedea Pessary pHyphpHyph, vaginal tablet, daily in Part 1 and once weekly in Part 2 |
| Placebo | Placebo comparator | Device: Placeboplacebo, vaginal tablet, daily in Part 1 and once weekly in Part 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 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.) until Day 7 and the following 24 hours after each treatment during weekly treatment.
Key exclusion criteria (11 listed)
- Patients with known or apparent signs of other infectious causes of vaginitis (e.g.
- 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 5).
- Patients who are pregnant or breastfeeding.
- Patients who are planning to conceive within the 128 days study duration.
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 |
|---|---|---|
| Gedea Pessary pHyphVaginal tablet | Device | Gedea Pessary |
| PlaceboVaginal tablet | Device | Placebo |
Primary outcome
Clinical cure rate on Day 7
Time frame: Day 7
o 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 odour "i.e. a positive whiff test" when alkali (10% KOH solution) is added.
3 secondary outcomes
Safety and local tolerability of Gedea Pessary - based on reported treatment-emergent AEs up until Day 7.
Time frame: Day 7
Clinical cure rate on Day 7, defined as clinical cure according to primary endpoint and Nugent score <4, i.e. both criteria have to be fulfilled.
Time frame: Day 7
Difference between Day 7 and Days 35, 63, 91, 128 and/or Day of possible recurrence confirmation (assessed by Amsel criteria), respectively, in the occurrence of anaerobic vaginal dysbiosis as assessed by analysis of the vaginal microbiome.
Time frame: Day 35, 63, 91, and 128, respectively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gedea Pessary pHyph in people with Bacterial Vaginosis, run by Gedea Biotech AB at 5 sites in 2 countries.
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 8 inclusion and 11 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 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 on Day 7 (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 18 Aug 2022.