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NCT Number: NCT01125410

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

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.

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Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

AZ Imelda Ziekenhuis, Bonheiden, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dequalinium chloride

Drug

Vaginal tablet, 10mg, 1 tablet daily for 6 days

Clindamycin

Drug

vaginal cream, 2%, once daily for 7 days

Primary outcomes

  1. clinical cure rate

    Time frame: 1 week (on average)

    Clinical cure rate based on Amsel criteria. For cure, clue cells have to be negative and not more than one of the other criteria positive

  2. Clinical cure rate

    Time frame: 4 weeks (on average)

    Clinical cure rate based on Amsel criteria, where cure was defined as clue cells being negative and not more than one of the other criteria positive

Secondary outcomes

  1. Treatment failure

    Time frame: 4 weeks

    Treatment failures include non-responders and recurrences

  2. Incidence of ADRs

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Medinova AG

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
May 18, 2010
Registry last updated
May 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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