Vaginosis, BacterialNCT05649735
EFFICACY AND SAFETY OF OVA AND LAVAGE MEDICAL DEVICES IN THE TREATMENT OF NON-SPECIFIC VULVOVAGINITIS
A study testing Logusgyn ovules and Logusgyn Lavander in people with Vaginosis, Bacterial, run by Ospedale del Mare at 1 site in Italy.
Trial summary
To evaluate and compare the efficacy, activity and tolerability of a vaginal ova formulation containing tindalised cultures (Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Streptococcus thermophilus) (LOGUSGYN/CANDIDEP OVULES) and in vaginal lavage (LOGUSGYN/CANDIDEP LAVENDER) in patients… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Vaginosis, Bacterial
- What is being tested?
- Logusgyn ovules and Logusgyn Lavander
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jul 2020to 13 Aug 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Subjects diagnosed with vulvovaginitis
- Presence of at least two subjective symptoms and two objective signs (at least moderate) of vaginal inflammation. Vaginal inflammation will be assessed on six subjective symptoms (burning, pain, itching, vaginal dryness, dyspareunia and dysuria and four objective signs (leucorrhoea, vulvar erythema, vulvar oedema and presence of abrasion/erosion)
- The patient is able to read and understand the language and content of the study material, understand the requirements for follow-up visits, willing and able to provide information at scheduled assessments and willing and able to fulfil the requirements of the study
- PAP positive patients were allocated to group D
Who cannot join
- Persons who do not meet the inclusion criteria
- Patients who do not sign the informed consent form
- Other gynaecological diseases (in addition to cervicovaginitis), immunosuppressive diseases (i.e. HIV infection) or who are immunocompromised for reasons such as corticosteroid therapy, chemotherapy, anti-angiogenic agents or immunosuppressants
- Patients being treated with antibiotics, anti-inflammatory agents, analgesics, antineoplastic or immunosuppressive drugs within 10 days prior to inclusion in the study
- History of connective tissue disease, e.g. systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome or mixed connective tissue disease
- Known allergy to any component of the device
- Subjects who are unable to understand informed consent or who have a high probability of noncompliance with study procedures and/or noncompletion of the study in the judgment of the investigator
- Time between last day of last menstruation and baseline visit> 16 days or ≤5 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTIVENESS AND SAFETY OF THE MEDICAL DEVICES LOGUSGYN ,CANDIDEP (OVULI: LOGUSGYN OVULI - FLI.000003 /CANDIDEP OVULI - FEI.000404 AND LAVENDER: LOGUSGYN Lavender - FLI.000002 / CANDIDEP LAVENDER FEI.000409) IN THE TREATMENT OF NON-SPECIFIC VULVOVAGINITIS: RANDOMISED STUDY WITH 4-ARM SEQUENTIAL DESIGN'
To evaluate and compare the efficacy, activity and tolerability of a vaginal ova formulation containing tindalised cultures (Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Streptococcus thermophilus) (LOGUSGYN/CANDIDEP OVULES) and in vaginal lavage (LOGUSGYN/CANDIDEP LAVENDER) in patients with nonspecific vulvovaginitis compared to sterile saline-based vaginal irrigation (AELAV PURLING). The primary efficacy endpoint is based on the percentage of patients with therapeutic success, defined as resolution of signs and symptoms of vaginitis (total symptom score <4) at the end of treatment. For the overall assessment of clinical outcomes (resolution, improvement or failure): outcomes at the end of treatment will be considered. The treatment outcome will be measured after 5 days (V2) and after 10 days of treatment (V3) for groups A, B and C Also for group D (later, with a second randomisation, divided into groups E and F) the primary endpoint will be the same as for groups A, B, C at the visit after 30 days of treatment (V4) The treatment outcome will be measured after 5 days (V2) (after 10 days (V3) of treatment the SPT result will be re-evaluated and will be included in the secondary endpoints). The evolution of signs and symptoms of vaginitis is defined as the percentage of patients with resolution (overall score 4), improvement (decrease in overall score from baseline of 50%) or failure (decrease in overall score <50%).
Ninety-one adult female subjects (aged 18-65 years) with a diagnosis of vulvovaginitis and the presence of at least two subjective symptoms and two objective signs (at least moderate) of vaginal inflammation were recruited.
Read more
The study was planned with a randomised, controlled, parallel-group sequential design to test a vaginal ova formulation containing tindalised cultures (Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Streptococcus thermophilus) (LOGUSGYN/CANDIDEP OVULES) and vaginal douches (LOGUSGYN/CANDIDEP LAVENDER) in patients with non-specific vulvovaginitis to control treatment (AELAV PURLING- vaginal irrigation with sterile saline). The sequential design involves a first phase with randomisation into 4 groups (A, B, C, D) followed by a second randomisation of group D (patients with vulvovaginitis and positive for HPV at PAP test) into two subgroups (E and F). The primary efficacy endpoint is based on the resolution of vulvovaginitis signs and symptoms (total SPT symptom score at the end of the first Phase I treatment period (after 5 days of treatment) for groups A, B, C and D). For the overall assessment of clinical outcomes (resolution, improvement or failure): results at the end of treatment after 10 days (V3) will be considered as secondary endpoints. Phase II will always have the resolution of vulvovaginitis signs and symptoms (total SPT symptom score f4 at the end of treatment at 30 days (V4)) as the primary endpoint, compared to Phase I results in group D.
The protocol involves 4 visits per patient over 10 days for the groups.
For groups E and F only the visit at V4 after 30 days of treatment. At visit 1 (0 days, baseline visit), patients will have to sign a written informed consent before performing any procedure. Subjects will be screened for study eligibility, verifying that all inclusion criteria and no exclusion criteria are met. At V1, the investigator will collect demographic and anamnestic data and perform a vaginal swab; in case of specific growth of pathogenic organisms, patients will be treated after the 5-day follow-up visit with antibiotics or antimycotics according to the result of the antibiogram. Delivery of the information note to the GP and the study and treatment information sheet to the patient. The investigator will then assess subjective symptomatology (burning, pain, itching, vaginal dryness, dyspareunia and dysuria) Objective symptomatology (leucorrhoea, vulvar erythema, vulvar oedema and presence of abrasion/erosion) Vaginal PH PAP test. Patients will report their degree of satisfaction with the treatment using a 5-point semiquantitative scale. Patients will be interviewed to monitor adherence to the study protocol and symptom trends during the 10-day study period (groups A, B, C and D) and at 30 days (groups E, F) The safety and tolerability of the treatments will be assessed by reporting any local and anticipated adverse events
- Conditions
- Vaginosis, Bacterial
- Being tested
- Logusgyn ovules, Logusgyn Lavander, 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.
Logusgyn ovulesDevice
LOGUSGYN ovules is a CE certified Class I medical device, according to MD Directive 93/42 / EEC as amended by Directive 2007/47 / EC, manufactured by ERBOZETA S.p.a. designed for its intended use. It consists of a vaginal ova dressing for topical use containing tindalised cultures, Guar fibre, Lactic acid and Calendula.
It is supplied in a container with 10 vaginal ova. For this study, LOGUSGYN/CANDIDEP ova/wash will be packaged according to good manufacturing practice and local regulatory requirements and will be labelled in accordance with local regulatory requirements and according to GMP Annex 13.
Logusgyn LavanderDevice
LOGUSGYN lavage is a CE certified class I medical device, according to MD Directive 93/42 / EEC as amended by Directive 2007/47 / EC, manufactured by ERBOZETA S.p.a. designed for its intended use. It consists of a gynaecological lavage dressing containing Chlorhexidine 0.2% and tindalised ferments, lactic acid, bisabolol.
It is supplied in a container with 5 vaginal douches.
For this study, LOGUSGYN/CANDIDEP ova/wash will be packaged according to good manufacturing practice and local regulatory requirements and will be labelled in accordance with local regulatory requirements and according to GMP Annex 13.
PlaceboOther
Also called Vaginal irrigation with sterile saline AELAV PURLING
Sterile saline solution
| Study group | Role | What they receive |
|---|---|---|
| GROUP A- LOGUSGYN/CANDIDEP vaginal ovules, | Experimental | At baseline, eligible and PAP test negative patients were randomly assigned to receive LOGUSGYN/CANDIDEP vaginal ovules treatment for 10 consecutive days. Receives: Device: Logusgyn ovules |
| GROUP B- LOGUSGYN/CANDIDEP lavander | Experimental | At baseline, eligible and PAP test negative patients were randomly assigned to receive LOGUSGYN/CANDIDEP lavender treatment for 10 consecutive days. Receives: Device: Logusgyn Lavander |
| GROUP C- vaginal irrigation with sterile saline AELAV PURLING | Placebo comparator | At the baseline visit, eligible and PAP test negative patients were randomly assigned to receive the vaginal irrigation with sterile saline AELAV PURLING treatment for 10 consecutive days. Receives: Other: Placebo |
| GROUP D- Patients pap test positive | Experimental | Patients eligible at baseline and PAP test positive will be assigned to GROUP D and treated for 10 days with sterile saline-based vaginal irrigation (Placebo/control group) AELAV PURLING- Subsequently after the initial 10-day treatment they will be randomised into two further groups, E and F, and treated for 30 days with: GROUP E- LOGUSGYN/CANDIDEP vaginal ova, GROUP F- LOGUSGYN/CANDIDEP vaginal ova, + LOGUSGYN/CANDIDEP lavage, and treated for 30 days with: GROUP E- LOGUSGYN/CANDIDEP vaginal ova, GROUP F- LOGUSGYN/CANDIDEP vaginal ova, + LOGUSGYN/CANDIDEP douche Receives: Device: Logusgyn ovules; Device: Logusgyn Lavander |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic success
resolution of signs and symptoms of vaginitis (total symptom score <4) at the end of treatment
Measured: After 5 days (V2)
Therapeutic success
resolution of signs and symptoms of vaginitis (total symptom score <4) at the end of treatment
Measured: After 10 days of treatment (V3) for groups A, B, C and D.
The evolution of signs and symptoms of vaginitis
the percentage of patients with resolution (overall score ≤ 4), improvement (decrease in overall score from baseline ≥ 50%), or failure (decrease in overall score <50%)
Measured: After 5 days (V2)
The evolution of signs and symptoms of vaginitis
the percentage of patients with resolution (overall score ≤ 4), improvement (decrease in overall score from baseline ≥ 50%), or failure (decrease in overall score <50%)
Measured: After 10 days of treatment (V3) for groups A, B, C and D.
Secondary outcomes (5)
the change from the semi-quantitative baseline score, expressed both for individual signs and symptoms and for their sum (total symptom score, TSS)
Measured: After 5 days (V2)
the change from the semi-quantitative baseline score, expressed both for individual signs and symptoms and for their sum (total symptom score, TSS)
Measured: After 10 days of treatment (V3) for groups A, B, C and D.
Vaginal pH
Measured: After 10 days of treatment (V3) for groups A, B, C and D.
Evaluation of the pap test
hpv molecular swab
Measured: After 5 days (V2)
Evaluation of the pap test
hpv molecular swab
Measured: After 10 days of treatment (V3) for groups A, B, C and D.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start17 Jul 2020
- Primary completion15 Dec 2021
- Study completion13 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginosis, BacterialStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale del Mare
- Sponsor type
- University, hospital or other
- Collaborators
- Erbozeta S.p.A
- Responsible party
- Principal investigator, Francesco Forleo, Unita Complessa di Ostetricia e Ginecologia
- Investigators
- Francesco Forleo, yes, Principal investigator, Erbozeta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649735
- Sponsor's protocol ID
- ERBOLOGUS-CL-001-01
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS AND SAFETY OF THE MEDICAL DEVICES LOGUSGYN ,CANDIDEP (OVULI: LOGUSGYN OVULI - FLI.000003 /CANDIDEP OVULI - FEI.000404 AND LAVENDER: LOGUSGYN Lavender - FLI.000002 / CANDIDEP LAVENDER FEI.000409) IN THE TREATMENT OF NON-SPECIFIC VULVOVAGINITIS: RANDOMISED STUDY WITH 4-ARM SEQUENTIAL DESIGN'
- ClinicalTrials.gov ID
- NCT05649735
- Acronym / sponsor ID
- ERBOLOGUS-CL-001-01
- Conditions
- Vaginosis, Bacterial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Ospedale del MareUniversity, hospital or other
- Collaborators
- Erbozeta S.p.A
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 13 Aug 2022 (actual)
- First posted
- 14 Dec 2022 (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.
To evaluate and compare the efficacy, activity and tolerability of a vaginal ova formulation containing tindalised cultures (Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Streptococcus thermophilus) (LOGUSGYN/CANDIDEP OVULES) and in vaginal lavage (LOGUSGYN/CANDIDEP LAVENDER) in patients with nonspecific vulvovaginitis compared to sterile saline-based vaginal irrigation (AELAV PURLING). The primary efficacy endpoint is based on the percentage of patients with therapeutic success, defined as resolution of signs and symptoms of vaginitis (total symptom score <4) at the end of treatment. For the overall assessment of clinical outcomes (resolution, improvement or failure): outcomes at the end of treatment will be considered. The treatment outcome will be measured after 5 days (V2) and after 10 days of treatment (V3) for groups A, B and C Also for group D (later, with a second randomisation, divided into groups E and F) the primary endpoint will be the same as for groups A, B, C at the visit after 30 days of treatment (V4) The treatment outcome will be measured after 5 days (V2) (after 10 days (V3) of treatment the SPT result will be re-evaluated and will be included in the secondary endpoints). The evolution of signs and symptoms of vaginitis is defined as the percentage of patients with resolution (overall score 4), improvement (decrease in overall score from baseline of 50%) or failure (decrease in overall score <50%).
Ninety-one adult female subjects (aged 18-65 years) with a diagnosis of vulvovaginitis and the presence of at least two subjective symptoms and two objective signs (at least moderate) of vaginal inflammation were recruited.
The study was planned with a randomised, controlled, parallel-group sequential design to test a vaginal ova formulation containing tindalised cultures (Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Streptococcus thermophilus) (LOGUSGYN/CANDIDEP OVULES) and vaginal douches (LOGUSGYN/CANDIDEP LAVENDER) in patients with non-specific vulvovaginitis to control treatment (AELAV PURLING- vaginal irrigation with sterile saline). The sequential design involves a first phase with randomisation into 4 groups (A, B, C, D) followed by a second randomisation of group D (patients with vulvovaginitis and positive for HPV at PAP test) into two subgroups (E and F). The primary efficacy endpoint is based on the resolution of vulvovaginitis signs and symptoms (total SPT symptom score at the end of the first Phase I treatment period (after 5 days of treatment) for groups A, B, C and D). For the overall assessment of clinical outcomes (resolution, improvement or failure): results at the end of treatment after 10 days (V3) will be considered as secondary endpoints. Phase II will always have the resolution of vulvovaginitis signs and symptoms (total SPT symptom score f4 at the end of treatment at 30 days (V4)) as the primary endpoint, compared to Phase I results in group D.
The protocol involves 4 visits per patient over 10 days for the groups.
For groups E and F only the visit at V4 after 30 days of treatment. At visit 1 (0 days, baseline visit), patients will have to sign a written informed consent before performing any procedure. Subjects will be screened for study eligibility, verifying that all inclusion criteria and no exclusion criteria are met. At V1, the investigator will collect demographic and anamnestic data and perform a vaginal swab; in case of specific growth of pathogenic organisms, patients will be treated after the 5-day follow-up visit with antibiotics or antimycotics according to the result of the antibiogram. Delivery of the information note to the GP and the study and treatment information sheet to the patient. The investigator will then assess subjective symptomatology (burning, pain, itching, vaginal dryness, dyspareunia and dysuria) Objective symptomatology (leucorrhoea, vulvar erythema, vulvar oedema and presence of abrasion/erosion) Vaginal PH PAP test. Patients will report their degree of satisfaction with the treatment using a 5-point semiquantitative scale. Patients will be interviewed to monitor adherence to the study protocol and symptom trends during the 10-day study period (groups A, B, C and D) and at 30 days (groups E, F) The safety and tolerability of the treatments will be assessed by reporting any local and anticipated adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GROUP A- LOGUSGYN/CANDIDEP vaginal ovules, | Experimental | Device: Logusgyn ovulesAt baseline, eligible and PAP test negative patients were randomly assigned to receive LOGUSGYN/CANDIDEP vaginal ovules treatment for 10 consecutive days. |
| GROUP B- LOGUSGYN/CANDIDEP lavander | Experimental | Device: Logusgyn LavanderAt baseline, eligible and PAP test negative patients were randomly assigned to receive LOGUSGYN/CANDIDEP lavender treatment for 10 consecutive days. |
| GROUP C- vaginal irrigation with sterile saline AELAV PURLING | Placebo comparator | Other: PlaceboAt the baseline visit, eligible and PAP test negative patients were randomly assigned to receive the vaginal irrigation with sterile saline AELAV PURLING treatment for 10 consecutive days. |
| GROUP D- Patients pap test positive | Experimental | Device: Logusgyn ovules, Device: Logusgyn LavanderPatients eligible at baseline and PAP test positive will be assigned to GROUP D and treated for 10 days with sterile saline-based vaginal irrigation (Placebo/control group) AELAV PURLING- Subsequently after the initial 10-day treatment they will be randomised into two further groups, E and F, and treated for 30 days with: GROUP E- LOGUSGYN/CANDIDEP vaginal ova, GROUP F- LOGUSGYN/CANDIDEP vaginal ova, + LOGUSGYN/CANDIDEP lavage, and treated for 30 days with: GROUP E- LOGUSGYN/CANDIDEP vaginal ova, GROUP F- LOGUSGYN/CANDIDEP vaginal ova, + LOGUSGYN/CANDIDEP douche |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed written informed consent
- Subjects diagnosed with vulvovaginitis
- Presence of at least two subjective symptoms and two objective signs (at least moderate) of vaginal inflammation. Vaginal inflammation will be assessed on six subjective symptoms (burning, pain, itching, vaginal dryness, dyspareunia and dysuria and four objective signs (leucorrhoea, vulvar erythema, vulvar oedema and presence of abrasion/erosion)
- The patient is able to read and understand the language and content of the study material, understand the requirements for follow-up visits, willing and able to provide information at scheduled assessments and willing and able to fulfil the requirements of the study
- PAP positive patients were allocated to group D
Key exclusion criteria (8 listed)
- Persons who do not meet the inclusion criteria
- Patients who do not sign the informed consent form
- Other gynaecological diseases (in addition to cervicovaginitis), immunosuppressive diseases (i.e. HIV infection) or who are immunocompromised for reasons such as corticosteroid therapy, chemotherapy, anti-angiogenic agents or immunosuppressants
- Patients being treated with antibiotics, anti-inflammatory agents, analgesics, antineoplastic or immunosuppressive drugs within 10 days prior to inclusion in the study
- History of connective tissue disease, e.g. systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome or mixed connective tissue disease
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 |
|---|---|---|
| Logusgyn ovulesLOGUSGYN ovules is a CE certified Class I medical device, according to MD Directive 93/42 / EEC as amended by Directive 2007/47 / EC, manufactured by ERBOZETA S.p.a. designed for its intended use. It consists of a vaginal ova dressing for topical use containing tindalised cultures, Guar fibre, Lactic acid and Calendula. It is supplied in a container with 10 vaginal ova. For this study, LOGUSGYN/CANDIDEP ova/wash will be packaged according to good manufacturing practice and local regulatory requirements and will be labelled in accordance with local regulatory requirements and according to GMP Annex 13. | Device | GROUP A- LOGUSGYN/CANDIDEP vaginal ovules,, GROUP D- Patients pap test positive |
| Logusgyn LavanderLOGUSGYN lavage is a CE certified class I medical device, according to MD Directive 93/42 / EEC as amended by Directive 2007/47 / EC, manufactured by ERBOZETA S.p.a. designed for its intended use. It consists of a gynaecological lavage dressing containing Chlorhexidine 0.2% and tindalised ferments, lactic acid, bisabolol. It is supplied in a container with 5 vaginal douches. For this study, LOGUSGYN/CANDIDEP ova/wash will be packaged according to good manufacturing practice and local regulatory requirements and will be labelled in accordance with local regulatory requirements and according to GMP Annex 13. | Device | GROUP B- LOGUSGYN/CANDIDEP lavander, GROUP D- Patients pap test positive |
| PlaceboAlso: Vaginal irrigation with sterile saline AELAV PURLINGSterile saline solution | Other | GROUP C- vaginal irrigation with sterile saline AELAV PURLING |
Primary outcome
Therapeutic success
Time frame: After 5 days (V2)
resolution of signs and symptoms of vaginitis (total symptom score <4) at the end of treatment
Therapeutic success
Time frame: After 10 days of treatment (V3) for groups A, B, C and D.
resolution of signs and symptoms of vaginitis (total symptom score <4) at the end of treatment
The evolution of signs and symptoms of vaginitis
Time frame: After 5 days (V2)
the percentage of patients with resolution (overall score ≤ 4), improvement (decrease in overall score from baseline ≥ 50%), or failure (decrease in overall score <50%)
The evolution of signs and symptoms of vaginitis
Time frame: After 10 days of treatment (V3) for groups A, B, C and D.
the percentage of patients with resolution (overall score ≤ 4), improvement (decrease in overall score from baseline ≥ 50%), or failure (decrease in overall score <50%)
5 secondary outcomes
the change from the semi-quantitative baseline score, expressed both for individual signs and symptoms and for their sum (total symptom score, TSS)
Time frame: After 5 days (V2)
the change from the semi-quantitative baseline score, expressed both for individual signs and symptoms and for their sum (total symptom score, TSS)
Time frame: After 10 days of treatment (V3) for groups A, B, C and D.
Vaginal pH
Time frame: After 10 days of treatment (V3) for groups A, B, C and D.
Evaluation of the pap test
Time frame: After 5 days (V2)
Evaluation of the pap test
Time frame: After 10 days of treatment (V3) for groups A, B, C and D.
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 14 Dec 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.
Francesco Forleo, yes principal investigator
Erbozeta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Logusgyn ovules and Logusgyn Lavander in people with Vaginosis, Bacterial, run by Ospedale del Mare at 1 site in Italy.
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 5 inclusion and 8 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 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Therapeutic success (time frame: After 5 days (V2)). The study lists 4 primary outcomes in all. 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 14 Dec 2022.