Safety and Efficacy Study to Treat Bacterial Vaginosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT01621399
First received: June 14, 2012
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621399

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

No publications provided

Responsible Party: Medicis Global Service Corporation
ClinicalTrials.gov 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
Genital Diseases, Female
Vaginal Diseases
Vaginitis

ClinicalTrials.gov processed this record on October 22, 2014