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OpenTrials
Completed

NCT Number: NCT00556179

Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis

The purpose of this study is to demonstrate if the use of Dermacyd can avoid the recurrence of bacterial vaginosis after three months of the standard treatment.

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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–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-aventis

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women in reproductive age
  • Confirmed cure of bacterial vaginosis after treatment with oral metronidazole.
  • Vaginal bacterioscopic examination negative for candida and trichomonas.

Exclusion criteria

  • Pregnant or breastfeeding women
  • Allergy to dermacyd

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Lactoserum (Dermacyd Femina®)

Drug

Once a day during three months

Primary outcomes

  1. Rate of recurrence of bacterial vaginosis after three months of treatment.

    Time frame: Three months

Secondary outcomes

  1. Quality of life

    Time frame: Three months

  2. Vaginal Candidiasis

    Time frame: Three months

  3. AE, particularly genital irritation (tolerability use of dermacyd)

    Time frame: During the study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Local, National (Brazil), Multicentric, Open, Non-Controlled, Phase IV, Study of Lactoserum (Dermacyd Femina®), in Women at Reproductive Age, to Prevent Recurrence of Bacterial Vaginosis, During Three Months, After Standard Treatment With Metronidazole.

Important dates

Study start
2007
Primary completion
2008
First posted
Nov 9, 2007
Registry last updated
Jan 22, 2009

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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