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Vaginal Infection Study

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ClinicalTrials.gov Identifier: NCT00616330
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : March 5, 2012
Sponsor:
Information provided by (Responsible Party):
Lumara Health, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Vulvovaginitis Vaginitis Drug: clindamycin phosphate/butoconazole nitrate Drug: clindamycin phosphate Drug: butoconazole nitrate Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1443 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Clinical symptom resolution. [ Time Frame: baseline, 7 to 10 days and 21 to 30 days ]

Secondary Outcome Measures :
  1. Yeast Culture for Candida [ Time Frame: baseline, 7 to 10 days and 21 to 30 days ]
    Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response

  2. Gram stain Nugent score [ Time Frame: baseline, 7 to 10 days and 21 to 30 days ]
    Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution

  3. Saline wet mount for clue cells [ Time Frame: baseline, 7 to 10 days and 21 to 30 days ]
    Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes 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.

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 ClinicalTrials.gov identifier (NCT number): NCT00616330


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

Responsible Party: Lumara Health, Inc.
ClinicalTrials.gov Identifier: NCT00616330     History of Changes
Other Study ID Numbers: CBC-302-602-622467
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: February 2012

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