Safety and Efficacy Study to Treat Bacterial Vaginosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01621399
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : August 21, 2013
Information provided by (Responsible Party):
Medicis Global Service Corporation

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 651 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : May 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
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.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01621399

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

Responsible Party: Medicis Global Service Corporation Identifier: NCT01621399     History of Changes
Other Study ID Numbers: MP-1601-01
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: August 21, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections