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OpenTrials
Completed

NCT Number: NCT00694928

Vaginal Infection Study 2

This study will evaluate the efficacy and safety of a vaginal product compared with that of another vaginal product in the treatment of vaginal infections.

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Key information

Conditions

Vaginal Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Diseases Vaginitis

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Bangalore Diabetes Centre, Bangalore, Karnataka, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must have a clinical diagnosis of vaginal infection.
  • Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control.

Exclusion criteria

  • Patients must not have any other infections
  • May not be pregnant or nursing
  • May not be receiving any other antimicrobial therapies or any medications that would interfere with the outcome of the study.

Treatment and study plan

clindamycin phosphate/butoconazole nitrate

Drug

semi-solid, single dose

butoconazole nitrate

Drug

semi-solid, single dose

Primary outcomes

  1. Clinical symptom resolution

    Time frame: baseline, 7 to 10 days and 21 to 30 days

Secondary outcomes

  1. Yeast Culture for Candida

    Time frame: baseline, 7 to 10 days and 21 to 30 days

    Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response

  2. Gram Stain Nugent Score

    Time frame: baseline, 7 to 10 days and 21 to 30 days

    Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution

  3. Saline wet mount for clue cells

    Time frame: baseline, 7 to 10 days and 21 to 30 days

    Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution

Sponsors and collaborators

Lead sponsor

Lumara Health, Inc.

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 11, 2008
Registry last updated
Mar 5, 2012

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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