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Completed

NCT Number: NCT01621399

Safety and Efficacy Study to Treat Bacterial Vaginosis

The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of 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 and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have a clinical diagnosis of bacterial vaginosis as determined by the investigator.
  • Other items as identified in the protocol.

Exclusion criteria

  • Have a known or suspected other infectious cause of vulvovaginitis.
  • Other items as identified in the protocol.

Treatment and study plan

Product 55394

Drug

Product 55394 vaginal gel in a prefilled applicator.

Placebo Vehicle (non-treatment)

Drug

The vehicle vaginal gel in an applicator (placebo).

Primary outcomes

  1. Clinical Cure

    Time frame: Day 21

    The proportion of subjects with a clinical cure at the Day 21 visit, as assessed by the investigator.

Secondary outcomes

  1. Therapeutic Cure

    Time frame: Day 21

    The proportion of subjects with a therapeutic cure at the Day 21 visit. Therapeutic cure is defined as both a clinical cure and bacteriological cure as assessed by the investigator and the central laboratory, respectively.

Sponsors and collaborators

Lead sponsor

Medicis Global Service Corporation

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of Product 55394 in the Treatment of Bacterial Vaginosis

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 18, 2012
Registry last updated
Aug 21, 2013

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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