Safety and Efficacy Study to Treat Bacterial Vaginosis

This study has been completed.
Information provided by (Responsible Party):
Medicis Global Service Corporation Identifier:
First received: June 14, 2012
Last updated: August 20, 2013
Last verified: August 2013

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

Condition Intervention Phase
Bacterial Vaginosis
Drug: Product 55394
Drug: Placebo Vehicle (non-treatment)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official 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

Further study details as provided by Medicis Global Service Corporation:

Primary Outcome Measures:
  • Clinical Cure [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    The proportion of subjects with a clinical cure at the Day 21 visit, as assessed by the investigator.

Secondary Outcome Measures:
  • Therapeutic Cure [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    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.

Enrollment: 651
Study Start Date: May 2012
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vehicle
Treatment with the vehicle (placebo)
Drug: Placebo Vehicle (non-treatment)
The vehicle vaginal gel in an applicator (placebo).
Experimental: Product 55394
Treatment with product 55394
Drug: Product 55394
Product 55394 vaginal gel in a prefilled applicator.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01621399

  Show 37 Study Locations
Sponsors and Collaborators
Medicis Global Service Corporation
Study Director: Ron Staugaard Medicis Pharmaceutical
  More Information

No publications provided

Responsible Party: Medicis Global Service Corporation Identifier: NCT01621399     History of Changes
Other Study ID Numbers: MP-1601-01
Study First Received: June 14, 2012
Last Updated: August 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginal Diseases
Genital Diseases, Female processed this record on April 20, 2014