Vaginal Infection Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lumara Health, Inc.
ClinicalTrials.gov Identifier:
NCT00616330
First received: February 4, 2008
Last updated: February 29, 2012
Last verified: February 2012
  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:


Further study details as provided by Lumara Health, Inc.:

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
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: NCT00616330

  Show 133 Study Locations
Sponsors and Collaborators
Lumara Health, Inc.
Investigators
Study Director: Jim Joffrion Lumara Health, Inc.
  More Information

No publications provided

Responsible Party: Lumara Health, Inc.
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
Vulvovaginitis
Vaginitis
Vulvitis
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Butoconazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents

ClinicalTrials.gov processed this record on September 18, 2014