Comparative Study of the Efficacy of 10 mg Dequalinium Chloride (Fluomizin®) in the Local Treatment of Bacterial Vaginosis

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 500

Inclusion Criteria

1. Postmenarchal women aged 18 to 55 years which have not yet reached menopause
2. Diagnosis of bacterial vaginosis (all 4 Amsel criteria must be positive)
3. 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 – excluded are methods that involve materials sensitive to mineral oil, like condoms, diaphragms
4. Signed Written Informed Consent to participate in this study

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. Pregnancy or lactation
2. Uterine bleeding (including menstruation but not
including cervical contact bleeding on sampling) or
vaginal bleeding of unknown origin
3. Acute infections of the upper genital tract
4. Clinical Symptoms of a vulvovaginal Candidiasis
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, or Lincomycin
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,
Trichomonas vaginalis, Treponema pallidum, Herpes
simplex virus type 2, condylomata, human
immunodeficiency viruses (HIV)
13. Participation of patient in another investigational drug
study concomitantly or within 30 days prior to entry in
the study.
14. Parallel use of Erythromycin
15. Regional enteritis, ulcerative colitis or medical history of
antibiotics-induced colitis
16. Patient is relatives of, or staff directly reporting to, the
investigator
17. 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 is the assessment of clinical cure rate based on the Amsel criteria (vaginal pH > 4.5, presence of clue cells, KOH test as well as greyish white, malodorous discharge), where clinical cure is defined as: clue cells and 2 other criteria must be negative.;Secondary Objective: 1) Assessment of differences among treatments on<br>short- and long-term follow-up<br>2) Assessment of the physiological status of the vaginal<br>ecosystem during the respective treatments<br>3) Assessment of safety profile of Fluomizin;Primary end point(s): Clinical cure rate based on the Amsel criteria (vaginal pH > 4.5, presence of clue cells, KOH test, greyish white, malodorous discharge), where clinical cure is defined as: clue cells and 2 other criteria must be negative at visit C1

Secondary Outcome Measures

Name	Time	Method

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