An open-label, controlled, randomized, prospective, between groups, multicenter clinical trial on the efficacy and safety of Fitostimoline (vaginal cream, vaginal suppositories and vaginal solution) and of Tantum Rosa (vaginal cream and vaginal solution) in the treatment of the vaginosis (non specific vaginitis) - ND

Active, not recruiting

• Conditions: Patients with aspecific vaginosis and/or vulvo vaginitis; MedDRA version: 9.1Level: LLTClassification code 10046953Term: Vaginitis and vulvovaginitis, unspecified

• Registration Number: EUCTR2008-005007-26-IT
• Lead Sponsor: FARMACEUTICI DAMOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Female
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified