EFFICACY AND SAFETY OF OVA AND LAVAGE MEDICAL DEVICES IN THE TREATMENT OF NON-SPECIFIC VULVOVAGINITIS
Condition: Vaginosis, Bacterial
MeSH terms: Vaginosis, Bacterial; Vulvovaginitis
Study type: Interventional

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 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
    


Intervention name(s): Logusgyn ovules; Logusgyn Lavander; Placebo
Intervention type(s): Device; Device; Other
Intervention description(s): 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 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.; Sterile saline solution
Other intervention name(s): Vaginal irrigation with sterile saline AELAV PURLING
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment