Patients with aspecific vaginosis and/or vulvo vaginitis MedDRA version: 9.1 Level: LLT Classification code 10046953 Term: Vaginitis and vulvovaginitis, unspecified
Conditions
Interventions
Trade Name: FITOSTIMOLINE*CREMA VAG 20%+1%
Pharmaceutical Form: Vaginal cream
INN or Proposed INN: FRUMENTO ESTRATTO
Concentration unit: % percent
Concentration type: equal
Concentration number: 20-
I
Sponsors
FARMACEUTICI DAMOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female outpatients; Age ≥ 18 years and ≤ 70 years; Presence of at least two subjective symptoms and at least two signs at the gynaecological examination (of at least mild degree) indicative of vaginal phlogosis; Availability of abstaining from vaginal sexual intercourses during the study period; Start of the study within the 15th day of the menstrual cycle, in fertile women; Availability in taking part in the study and in adhering to experimental procedures by signing the informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy or lactation; Gynaecological diseases (in addition to the vaginal phlogosis) or other diseases whose symptoms or treatment could interfere with the evaluations scheduled in the protocol; Treatment with antibiotics/antisepticals, anti-inflammatory drugs (steroidal and non-steroidal), analgesic drugs, antineoplastic drugs or immunosuppressant drugs (by any route) in the last 10 days prior to the start of the study; Immunodepressant drugs (e.g. HIV infection); Non-therapeutic use of psychoactive drugs; Drug or alcohol abuse; Serious psychiatric diseases; Known hypersensitivity to study compounds; Presumed poor adherence or cooperation; Treatment with any investigational study drug in the last 30 days prior to the study start.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the efficacy in the two groups treated with Fitostimoline with that of the group treated with Tantum Rosa with regard the primary variable therapeutic success (resolution of signs and symptoms of vaginosis).;Secondary Objective: To assess the efficacy of the three investigational study drugs in the treatment of symptoms of the vaginosis, both expressed as overall assessment (resolution, improvement, failure) and as semi-quantitative score of individual signs and symptoms and their sum (Total Symptoms Score, TSS); To assess the safety of the three investigational study drugs;Primary end point(s): therapeutic success (resolution of signs and symptoms of vaginosis) | — |
Countries
Italy
Outcome results
None listed