Bacterial VaginosisNefertiti 2NCT06123299
A Randomised, Partly-blinded Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Bacterial Vaginosis Compared With an Untreated Control Group
A study testing pHyph in people with Bacterial Vaginosis, run by Gedea Biotech AB at 5 sites in Sweden.
Trial summary
This is a randomised, parallel group, partly blinded investigation to evaluate the clinical performance and safety of pHyph in adult women with bacterial vaginosis. Patients will be randomised to active treatment or no treatment (untreated controls) in a 1:1 ratio. 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
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 5 sitesSweden
- Study dates
- 20 Nov 2023to 4 Sep 2024
- 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
- Willing and able to give written informed consent for participation in the clinical investigation, and to comply with all clinical investigation requirements.
- 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, homogeneous discharge.
- Clue cells on microscopy (>20% of epithelial cells).
- pH of vaginal fluid >4.5.
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- Release of "fishy odour", i.e., a positive "whiff test" when alkali (10% KOH solution) is added. This symptom must be present.
- Negative urine pregnancy test at screening.
- Willing to refrain from using any intravaginal products (e.g., contraceptive creams, gels, foams, sponges, lubricants or tampons, etc.) until Day 7 and the following 24 hours after each pHyph administration during weekly treatment.
- Willing to use condoms during any sexual intercourse with a male sexual partner until the initial pHyph treatment is completes. For patients starting with pHyph on Day 0, this means from Visit 1 (Day 0) until Visit 2 (Day 7). For patients that do not receive any treatment between Day 0 and Day 7, this means from Visit 1 (Day 0), and if they receive pHyph from Day 7, until their Visit 2 (Day 14).
- Willing to use a method of contraception, e.g., condoms, hormonal contraception (oral, injectable, implantable, intravaginal, or transdermal), intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), during any sexual intercourse that might result in pregnancy from Visit 2 (Day 7 or 14) until Visit 4 (70-77 days) to prevent pregnancy.
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.
- History of or presence at screening (Day 0) of any other clinically significant disease or disorder, medical/surgical procedure, or trauma, which, in the opinion of the Investigator, may either put the patient at risk because of participation in the clinical investigation, or influence the results or the patient's ability to participate in the clinical investigation.
- Anticipated menstruation during the initial daily treatment period (Day 0 until Day 5).
- Patients who are pregnant or breastfeeding.
- Patients who are planning to conceive within the 70-77 days of the investigation.
- Patients who were treated for BV within the 14 days preceding screening.
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- Patients who are currently receiving antibiotic therapy unrelated to BV or have received antibiotic therapy within the 14 days preceding screening.
- Patients who have used any pH-modifying vaginal products within the 14 days preceding screening.
- Patients who have received an investigational drug in a clinical trial within 30 days prior to screening.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, to any of the product components.
- The Investigator considers the patient unlikely to comply with clinical investigation procedures, restrictions and requirements.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
CTC, Ebbe Park
Linköping
CTC GoCo
Mölndal, 451 53
CTC, Karolinska
Solna
Kvinnoforskningsenheten, KS Huddinge
Stockholm
CTC MTC
Uppsala
About this study
This is a randomised, parallel group, partly blinded investigation to evaluate the clinical performance and safety of pHyph in adult women with bacterial vaginosis. Patients will be randomised to active treatment or no treatment (untreated controls) in a 1:1 ratio. The Investigators carrying out the gynaecological assessments will be blinded. Patients will not be blinded.
The population of this investigation will consist of post-menarchal, pre-menopausal females 18 years or older seeking treatment for BV symptoms ("fishy smell", irritation and burning).
Read more
Approximately 82-92 patients will be recruited and randomised. BV will be diagnosed according to Amsel's criteria, defined as having at least 3 of the 4 criteria.
Active treatment (from the start of the investigation) will be compared to no treatment at day 7 after screening (primary endpoint). Clinical cure rate on Day 7 is defined as the absence of all of the following 3 Amsel criteria:
- Thin, white, yellow, homogeneous discharge.
- Clue cells on microscopy (>20% of epithelial cells).
- Release of a "fishy odour", i.e., a positive "whiff test" when alkali (10% KOH solution) is added.
Patients receiving rescue treatment before Day 7 will be considered as treatment failures.
Patients in the "no treatment group" will receive pHyph as rescue treatment if they are not cured day 7. They will thereafter follow the same scheme as the patients starting with pHyph treatment.
After the initial pHyph treatment, daily during 6 days, patients will continue with pHyph twice weekly until day 25 when an additional assessment will be performed. If the patients are cured, they will continue to receive pHyph as preventive treatment during 6 weeks and possible BV recurrences will be assessed.
- Conditions
- Bacterial Vaginosis
- Being tested
- pHyph
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pHyphDevice
vaginal tablet
| Study group | Role | What they receive |
|---|---|---|
| pHyph treatment | Active comparator | Initial treatment with pHyph vaginal tablet once daily during 6 consecutive days Receives: Device: pHyph |
| No treatment | No intervention | No initial treament during the first 7 days of the study |
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 the absence of all of the following 3 Amsel criteria:
- Thin, white, yellow, homogeneous discharge.
- Clue cells on microscopy (>20% of epithelial cells).
- Release of a "fishy odour", i.e., a positive "whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added.
Measured: 7 days
Secondary outcomes (20)
Proportion of patients that do not have the symptom "fishy odour" on Days 1 to 7 after start of treatment, compared to Day 0, measured by using a patient questionnaire administered via mobile application.
Measured: 7 days
Proportion of patients that do not have the symptom "fishy odour" on Day 7 after start of treatment, compared to Day 0, as assessed by the Investigator as part of the Amsel criteria.
Measured: 7 days
Proportion of patients having a reduction in each of 3 BV symptoms scores on Days 1 to 7 after start of treatment, compared to Day 0, measured by using a patient questionnaire administered via mobile application.
Measured: 7 days
Safety and local tolerability of pHyph for patients receiving daily treatment for 6 days, based on the reported treatment-emergent AEs up until Day 7 after start of treatment.
Measured: 7 days
Clinical cure rate on Day 7 after start of treatment, defined as clinical cure according to secondary endpoint 1 and Nugent score <4, i.e., both criteria have to be fulfilled.
Measured: 7 days
Clinical cure rate on Day 7 after start of treatment, defined as Nugent score <4.
Measured: 7 days
Usability measured using a patient questionnaire administered via mobile application on Day 7 and Day 25.
Measured: Day 7 and 25
Difference between Day 0, Day 7, and Day 25 after start of treatment in the occurrence of anaerobic vaginal dysbiosis, as assessed by analysis of the vaginal microbiome.
Measured: Day 25
Difference between Day 0, Day 7, and Day 25 after start of treatment in the occurrence of vaginal yeasts, as assessed by analysis of the vaginal microbiome.
Measured: Day 25
For the subgroup of patients with a Nugent score ≥7 on Day 0: Primary endpoint and secondary endpoints 1-4, and 6.
Measured: 7 days
Proportion of patients that do not have the symptom "fishy odour" on Day 25 after start of treatment, as assessed by the Investigator as part of the Amsel criteria.
Measured: 25 days
Proportion of patients that do not have the symptom fishy "odour" on Day 25 after start of treatment, as assessed by the Investigator as part of the Amsel criteria, and Nugent score <4, i.e., both criteria have to be fulfilled.
Measured: 25 days
Clinical cure rate on Day 25 after start of treatment, defined as clinical cure according to the primary endpoint.
Measured: 25 days
Clinical cure rate on Day 25 after start of treatment, defined as clinical cure according to the primary endpoint and Nugent score <4, i.e., both criteria have to be fulfilled.
Measured: 25 days
Proportion of patients having a reduction in pH on Day 7 after start of treatment compared to Day 0.
Measured: 7 days
Recurrence from day 25, as defined by vaginal dysbiosis
Difference between Visit 3, Day 55, and Visit 4, or day of possible recurrence confirmation, respectively, in the occurrence of anaerobic vaginal dysbiosis as assessed by analysis of the vaginal microbiome, in patients starting with active treatment on Day 0 and patients starting with active treatment on Day 7, respectively and together.
Measured: 70 days
Recurrence from day 7, as defined by clinical assessment
Recurrence rate from Day 7 in patients starting with active treatment on Day 0 (active treatment group) and patients starting with active treatment on Day 7 (no initial treatment group), respectively and together.
- Defined as the proportion of patients diagnosed with BV according to Amsel's criteria, defined as having at least 3 of the 4 criteria.
- Defined as the proportion of patients diagnosed with BV according to Amsel's criteria, defined as having at least 3 of the 4 criteria, and according to Nugent score defined as having a score of ≥7, i.e., both criteria have to be fulfilled.
- Defined as the presence of "fishy odour" reported by the patient in connection with reporting of the confirmed recurrence as defined in secondary endpoints 17a and 17b.
Measured: 70 days
Recurrence from day 25, as defined by clinical assessment
Recurrence rate from Day 25 in patients starting with active treatment on Day 0 (active treatment group) and patients starting with active treatment on Day 7 (no initial treatment group), respectively and together.
- Defined as the proportion of patients diagnosed with BV according to Amsel's criteria, defined as having at least 3 of the 4 criteria.
- Defined as the proportion of patients diagnosed with BV according to Amsel's criteria, defined as having at least 3 of the 4 criteria, and according to Nugent score defined as having a score of ≥7, i.e., both criteria have to be fulfilled.
- Defined as the presence of "fishy odour" reported by the patient in connection with reporting of the confirmed recurrence as defined in secondary endpoints 18a and 18b.
Measured: 70 days
Safety and local tolerability for patients receiving preventive treatment:
- Based on reported treatment-emergent adverse events (AEs) from Visit 3 up until Visit 4.
Measured: 70 days
Safety and local tolerability for patients receiving preventive treatment:
- Based on signs of erythema, oedema and excoriation on the vaginal mucosa, according to a scoring scale (0-3), assessed at Visit 1, 2, 3, and 4/or day of possible recurrence confirmation.
Measured: 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start20 Nov 2023
- Primary completion14 May 2024
- Study completion4 Sep 2024
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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gedea Biotech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aino Fianu Jonasson, Ass. Prof., Principal investigator, Karolinska Institute, Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123299
- Sponsor's protocol ID
- CL3-2
- Acronym
- Nefertiti 2
- Status last verified
- Mar 2025
- First submitted
- 2 Nov 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Partly-blinded Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Bacterial Vaginosis Compared With an Untreated Control Group
- ClinicalTrials.gov ID
- NCT06123299
- Acronym / sponsor ID
- Nefertiti 2 / CL3-2
- Conditions
- Bacterial Vaginosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Gedea Biotech ABIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 8 Nov 2023 (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, parallel group, partly blinded investigation to evaluate the clinical performance and safety of pHyph in adult women with bacterial vaginosis. Patients will be randomised to active treatment or no treatment (untreated controls) in a 1:1 ratio. The Investigators carrying out the gynaecological assessments will be blinded. Patients will not be blinded.
The population of this investigation will consist of post-menarchal, pre-menopausal females 18 years or older seeking treatment for BV symptoms ("fishy smell", irritation and burning).
Approximately 82-92 patients will be recruited and randomised. BV will be diagnosed according to Amsel's criteria, defined as having at least 3 of the 4 criteria.
Active treatment (from the start of the investigation) will be compared to no treatment at day 7 after screening (primary endpoint). Clinical cure rate on Day 7 is defined as the absence of all of the following 3 Amsel criteria:
- Thin, white, yellow, homogeneous discharge.
- Clue cells on microscopy (>20% of epithelial cells).
- Release of a "fishy odour", i.e., a positive "whiff test" when alkali (10% KOH solution) is added.
Patients receiving rescue treatment before Day 7 will be considered as treatment failures.
Patients in the "no treatment group" will receive pHyph as rescue treatment if they are not cured day 7. They will thereafter follow the same scheme as the patients starting with pHyph treatment.
After the initial pHyph treatment, daily during 6 days, patients will continue with pHyph twice weekly until day 25 when an additional assessment will be performed. If the patients are cured, they will continue to receive pHyph as preventive treatment during 6 weeks and possible BV recurrences will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pHyph treatment | Active comparator | Device: pHyphInitial treatment with pHyph vaginal tablet once daily during 6 consecutive days |
| No treatment | No intervention | –No initial treament during the first 7 days of the study |
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)
- Willing and able to give written informed consent for participation in the clinical investigation, and to comply with all clinical investigation requirements.
- 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:
- Negative urine pregnancy test at screening.
- Willing to refrain from using any intravaginal products (e.g., contraceptive creams, gels, foams, sponges, lubricants or tampons, etc.) until Day 7 and the following 24 hours after each pHyph administration 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.
- History of or presence at screening (Day 0) of any other clinically significant disease or disorder, medical/surgical procedure, or trauma, which, in the opinion of the Investigator, may either put the patient at risk because of participation in the clinical investigation, or influence the results or the patient's ability to participate in the clinical investigation.
- Anticipated menstruation during the initial daily treatment period (Day 0 until Day 5).
- Patients who are pregnant or breastfeeding.
- Patients who are planning to conceive within the 70-77 days of the investigation.
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 |
|---|---|---|
| pHyphvaginal tablet | Device | pHyph treatment |
Primary outcome
Clinical cure rate on Day 7
Time frame: 7 days
Defined as the absence of all of the following 3 Amsel criteria: * Thin, white, yellow, homogeneous discharge. * Clue cells on microscopy (>20% of epithelial cells). * Release of a "fishy odour", i.e., a positive "whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added.
20 secondary outcomes
Proportion of patients that do not have the symptom "fishy odour" on Days 1 to 7 after start of treatment, compared to Day 0, measured by using a patient questionnaire administered via mobile application.
Time frame: 7 days
Proportion of patients that do not have the symptom "fishy odour" on Day 7 after start of treatment, compared to Day 0, as assessed by the Investigator as part of the Amsel criteria.
Time frame: 7 days
Proportion of patients having a reduction in each of 3 BV symptoms scores on Days 1 to 7 after start of treatment, compared to Day 0, measured by using a patient questionnaire administered via mobile application.
Time frame: 7 days
Safety and local tolerability of pHyph for patients receiving daily treatment for 6 days, based on the reported treatment-emergent AEs up until Day 7 after start of treatment.
Time frame: 7 days
Clinical cure rate on Day 7 after start of treatment, defined as clinical cure according to secondary endpoint 1 and Nugent score <4, i.e., both criteria have to be fulfilled.
Time frame: 7 days
Clinical cure rate on Day 7 after start of treatment, defined as Nugent score <4.
Time frame: 7 days
Usability measured using a patient questionnaire administered via mobile application on Day 7 and Day 25.
Time frame: Day 7 and 25
Difference between Day 0, Day 7, and Day 25 after start of treatment in the occurrence of anaerobic vaginal dysbiosis, as assessed by analysis of the vaginal microbiome.
Time frame: Day 25
Difference between Day 0, Day 7, and Day 25 after start of treatment in the occurrence of vaginal yeasts, as assessed by analysis of the vaginal microbiome.
Time frame: Day 25
For the subgroup of patients with a Nugent score ≥7 on Day 0: Primary endpoint and secondary endpoints 1-4, and 6.
Time frame: 7 days
Proportion of patients that do not have the symptom "fishy odour" on Day 25 after start of treatment, as assessed by the Investigator as part of the Amsel criteria.
Time frame: 25 days
Proportion of patients that do not have the symptom fishy "odour" on Day 25 after start of treatment, as assessed by the Investigator as part of the Amsel criteria, and Nugent score <4, i.e., both criteria have to be fulfilled.
Time frame: 25 days
Clinical cure rate on Day 25 after start of treatment, defined as clinical cure according to the primary endpoint.
Time frame: 25 days
Clinical cure rate on Day 25 after start of treatment, defined as clinical cure according to the primary endpoint and Nugent score <4, i.e., both criteria have to be fulfilled.
Time frame: 25 days
Proportion of patients having a reduction in pH on Day 7 after start of treatment compared to Day 0.
Time frame: 7 days
Recurrence from day 25, as defined by vaginal dysbiosis
Time frame: 70 days
Recurrence from day 7, as defined by clinical assessment
Time frame: 70 days
Recurrence from day 25, as defined by clinical assessment
Time frame: 70 days
Safety and local tolerability for patients receiving preventive treatment:
Time frame: 70 days
Safety and local tolerability for patients receiving preventive treatment:
Time frame: 70 days
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 13 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Aino Fianu Jonasson, Ass. Prof. principal investigator
Karolinska Institute, Stockholm
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pHyph in people with Bacterial Vaginosis, run by Gedea Biotech AB at 5 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 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 13 Mar 2025. 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 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?
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: 7 days). 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 13 Mar 2025.