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Vaginal Infection Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
KV Pharmaceutical Company
ClinicalTrials.gov Identifier:
NCT00616330
First received: February 4, 2008
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Vulvovaginitis
Vaginitis
 Drug: clindamycin phosphate/butoconazole nitrate
Drug: clindamycin phosphate
Drug: butoconazole nitrate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by KV Pharmaceutical Company:

Primary Outcome Measures:
  • Clinical symptom resolution. [ Time Frame: baseline, 7 to 10 days and 21 to 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Yeast Culture for Candida [ Time Frame: baseline, 7 to 10 days and 21 to 30 days ] [ Designated as safety issue: No ]
    Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response

  • Gram stain Nugent score [ Time Frame: baseline, 7 to 10 days and 21 to 30 days ] [ Designated as safety issue: No ]
    Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution

  • Saline wet mount for clue cells [ Time Frame: baseline, 7 to 10 days and 21 to 30 days ] [ Designated as safety issue: No ]
    Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution


Enrollment: 1443
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
clindamycin phosphate/butoconazole nitrate
 Drug: clindamycin phosphate/butoconazole nitrate
semi solid, single dose
Active Comparator: 2
clindamycin phosphate
 Drug: clindamycin phosphate
semi solid, single dose
Active Comparator: 3
butoconazole nitrate
 Drug: butoconazole nitrate
semi solid, single dose

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616330

  Show 133 Study Locations
Sponsors and Collaborators
KV Pharmaceutical Company
Investigators
Study Director: Jim Joffrion KV Pharmaceutical Company
  More Information

No publications provided

Responsible Party: KV Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT00616330     History of Changes
Other Study ID Numbers: CBC-302-602-622467
Study First Received: February 4, 2008
Last Updated: February 29, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vaginal Diseases
Genital Diseases, Female
Vulvar Diseases
Vaginitis
Vulvovaginitis
Vulvitis
Clindamycin
Clindamycin-2-phosphate
Butoconazole
 Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antifungal Agents

ClinicalTrials.gov processed this record on May 21, 2013