Recurrent vulvovaginitis episodes MedDRA version: 19.0 Level: PT Classification code 10047794 Term: Vulvovaginitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Imunor
Product Name: Imunor
Pharmaceutical Form: Oral lyophilisate
Pharmaceutical form of the placebo: Oral lyophilisate
Rou
Sponsors
ImunomedicA, a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Females aged 18 - 50 years, without signs of menopause-related estrogen deficiency; 2.Suspected secondary immune deficiency based on presence of recurrent, symptomatic mycotic and/or bacterial vulvovaginitis episodes documented by a gynecologist (4 or more episodes during the last 12 months prior randomization, with the exception of mycotic episodes accompanying systemic administration of antibiotics); 3.Patients willing and able to sign the informed consent, cooperate and participate on prescribed study visits; 4.Stable sexual relationships 12 months prior signature of the informed consent and a prerequisite for maintaining them for the next 12 months; 5.Documented use of an effective contraception method, Pearl index = 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 123 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Subjects with known hypersensitivity to any ingredient of the study medication; 2.Pregnant or breast feeding females; 3.Females planning to get pregnant during the course of the next 12 months; 4.Known personal history of hypothyreosis (or suspected); 5.Known personal history of elevated anti-thyroidal antibodies; 6.Known personal history of an autoimmune or malignant disease; 7.Known personal history of HIV positivity, tuberculosis or intake of treatment lowering the function(s) of the immune system (e.g. immunosuppresants, chemotherapy), with the exception of treatment of bronchial asthma, or allergies (nasal or inhaled corticosteroids); 8.Known personal history of HIV positivity, tuberculosis or intake of treatment lowering the function(s) of the immune system (e.g. immunosuppresants, chemotherapy), with the exception of treatment of bronchial asthma, or allergies (nasal or inhaled corticosteroids); 9.Acute vulvovaginitis with presence of herpetic viruses or gonorrhea; 10.Evidence of chlamydia, trichomonads or an other sexually transmitted disease within 30 days prior the first study visit; 11.Use of immune modulation therapy (transfer factor, bacterial lysates, systemic enzymatic therapy, immunoglobulins) during the last 12 months prior the first study visit, or planned initiation of such treatment during the course of the study; 12.Use of vaginal probiotics, or antibiotics completed less than 30 days prior the first study visit; 13.Participation in another clinical trial within 30 days prior the first study visit; 14.Any clinically significant condition or disease, which in the opinion of the investigator, could affect safety of the patient or evaluation of this Study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm efficacy of IMUNOR® based on reduction of the number of mycotic and bacterial vulvovaginitis episodes during 12 months observation, compared to patients receiving placebo.; Secondary Objective: • To confirm efficacy of IMUNOR® based on reduction of the number of mycotic vulvovaginitis episodes during 6 months observation, as compared to placebo; • To compare the mean duration of mycotic vulvovaginitis episodes; • Comparison of the proportion of patients withdrawn from the study due to the need of use of oral antifungal medication; • To evaluate safety of the IMUNOR® treatment based on the assessment occurrence of adverse events and monitored laboratory parameters; • To compare the use of local symptomatic and/or topical antifungal treatment; • To assess the quality of life of patients; • To evaluate changes in vaginal biocenosis; • To evaluate basic pharmacoeconomics parameters. ; Primary end point(s): Assessment of IMUNOR®`s efficacy based on reduction of the number of vulvovaginitis episodes, with confirmed mycotic or bacterial etiology, during 12 months observation time, compared to patients receiving placebo. Episodes starting prior the first IMP administration will be documented, but not used for the analysis. All episodes starting during the second Observation Phase and being, or not, resolved after Visit 6 will be included into the analysis. If the patient terminates the Study prematurely then the number of vulvovaginitis episodes will be increased by one (1) episode. ;Timepoint(s) of evaluation of this end point: At the end of the study, after database lock. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At the end of the study, after database lock.; Secondary end point(s): •Confirmation of IMUNOR®`s efficacy based on reduction of the number of vulvovaginitis episodes, with confirmed mycotic or bacterial etiology, during the initial 6 months observation time, compared to patients receiving placebo. Episodes starting prior the first IMP administration will be documented, but not used for the analysis. All episodes starting during the first Observation Phase and being, or not, resolved after Visit 4 will be included into the analysis; •Comparison of the mean duration of all documented mycotic or bacterial vulvovaginitis episodes in patients receiving IMUNOR® or placebo. The analysis will be separately performed for the 6- and 12-months observation time as well as for vulvovaginitis episodes with bacterial and mycotic etiology; •Evaluation of safety of the IMUNOR® treatment based on: -occurrence of adverse events, -assessment of monitored laboratory parameters: Explorative Endpoint Analysis of selected immunological parameters in patients participating in the immunology sub-study - CD3, CD4, CD8, CD16/56, CD19, HLA-DR, phagocyte activity, total IgM, IgA, IgG and specific anti-D-mannan IgM and anti-D-glucan IgG antibodies. Values at the end of each IMP administration period will be compared with the baseline (Visit 1) and among both treatment groups. oHematology (hemoglobin, hematocrit, MCV, MCH, MCHC, RDW, total and differential leukocyte count, red blood cell count, platelet count, PDW), oSerum chemistry (glucose, total proteins, serum albumin, urea, serum creatinine, AST, ALT, total bilirubine, direct bilirubine, sodium, potassium, CRP), oUrine cultivation; •Assessment of the use of local symptomatic and/or topical antifungal or an | — |
Countries
Czech Republic, Slovakia
Contacts
Public ContactIng. Zdenka Svobodová
ImunomedicA, a.s.
Outcome results
None listed