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

Medinova

Status and phase: Completed; Phase 3

Conditions: Bacterial Vaginosis

Treatments: Drug: Clindamycin; Drug: Dequalinium chloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01125410

Med380104

Details and patient eligibility

About

The purpose of this clinical study was to evaluate whether vaginal tablets containing 10 mg dequalinium chloride (Fluomizin) are comparable in clinical efficacy and safety to clindamycin vaginal cream (2%) in patients suffering from bacterial vaginosis.

Full description

An international, multi-center, single-blind, randomized, active-controlled study with two parallel groups in patients with bacterial vaginosis. Eligible patients were randomized to receive Fluomizin vaginal tablets for 6 days or Clindamycin vaginal cream (2%) for 7 days. Control examinations were performed 3 to 14 days and 2 to 6 weeks after the end of the therapy.

Enrollment: 321 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of bacterial vaginosis
• Women aged 18-55 years

Exclusion criteria

• Pregnancy or lactation
• Uterine bleeding (including menstruation but not including cervical contact bleeding on sampling) or vaginal bleeding of unknown origin
• Acute infections of the upper genital tract
• Clinical Symptoms of a vulvovaginal Candidiasis
• Use of anti-infectives (local or systemic) in the previous 14 days and/or during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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321 participants in 2 patient groups

Dequalinium chloride 10mg

Experimental group

Treatment:

Drug: Dequalinium chloride

clindamycin vaginal cream 2%

Active Comparator group

Treatment:

Drug: Clindamycin