The Efficacy of 10 mg Dequalinium Chloride (Fluomizin®) in the Local Treatment of Aerobic Bacterial Vaginal Infections in Comparison to Placebo

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 210

Inclusion Criteria

1. Postmenarchal women aged 18 to 55 years which have not yet reached menopause
2. Signs and symptoms of aerobic bacterial vaginal infections, corresponding to a Total Symptoms Score =5 (discharge, pruritus, and burning are added using a 4-point scale)
3. Disturbed vaginal microflora with Lactobacillary Grade III
4. Cultural proof of at least one of the associated bacteria,
i.e. streptococci, enterococci, S. aureus, pseudomonas, E. coli or other enterobacteria
5.Patients of child bearing potential must be using a highly effective form of birth control such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or have a vasectomized partner
6. Signed Written 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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Diagnosis of Bacterial vaginosis and/or presence of clue cells
2. Diagnosis of vulvovaginal candidiasis based on clinical symptoms and/or microscopic examination of the vaginal smear
3. Pregnancy and lactation
4. Uterine bleeding (including menstruation but not including cervical contact bleeding on sampling) or vaginal bleeding of unknown origin
5. Use of anti-infectives (local or systemic) in the previous 14 days and/or during the study
6. Use of any vaginal medication in the previous 7 days
7. Use of vaginal douches, particularly containing soaps
and other anionic, surface-active substances, in the
previous 48 hours and/or during the entire duration of
the trial
8. Known or suspected hypersensitivity to one of the study medications, inclusive their excipients
9. Ulceration of the vulva, vagina or cervix (damaged vaginal surface)
10. Patients receiving systemic immunosuppressive therapy or who have immune system deficiency
11. Malignant tumours in the genital tract
12. Suspicion of or clinically manifest Sexually Transmitted Diseases (STDs), i.e: Neisseria gonorrhoea, Chlamydia trachomatis, Trichomonas vaginalis, Treponema
pallidum, Herpes simplex virus type 2, condylomata, human immunodeficiency viruses (HIV)
13. Acute infections of the upper genital tract
14. Participation of patient in another investigational drug study concomitantly or within 30 days prior to entry in the study
15. Patient is relative of or staff directly reporting to the investigator
16. Patient is employee of the sponsor

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate the efficacy of<br>Fluomizin vaginal tablets for the treatment of aerobic bacterial<br>vaginal infections associated with gram-positive cocci (e.g.<br>streptococci, enterococci, and Staphylococcus aureus) and/or<br>gram-negative rods (e.g. pseudomonas, E. coli and other<br>enterobacteria) in comparison to placebo. The primary efficacy<br>variable is the clinical cure rate based on both the Total<br>Symptoms Score (TSC) and the Lactobacillary Grade (LBG).;Secondary Objective: The trial should provide additional information on:<br>· The treatment success on short-term and long-term<br>follow-up<br>· The change of physiological status of the vaginal<br>ecosystem during the respective treatments<br>· The assessment of the safety profile of Fluomizin.;Primary end point(s): Clinical cure defined as a Total Symptoms Score = 1 together with Lactobacillary Grade = I at C2

Secondary Outcome Measures

Name	Time	Method

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