A Phase 3 interventional study of clindamycin phosphate/butoconazole nitrate and butoconazole nitrate in Vaginal Infection, sponsored by Lumara Health, Inc.. Completed at 73 sites in 3 countries. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2012-03-05.
Sponsored by Lumara Health, Inc. · Phase 3, Interventional, and Treatment
This study will evaluate the efficacy and safety of a vaginal product compared with that of another vaginal product in the treatment of vaginal infections.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 843 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Lumara Health, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
clindamycin phosphate/butoconazole nitrate
Drug: clindamycin phosphate/butoconazole nitrate
butoconazole nitrate
Drug: butoconazole nitrate
semi-solid, single dose
semi-solid, single dose
Clinical symptom resolution
Time frame: baseline, 7 to 10 days and 21 to 30 days
Yeast Culture for Candida
Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response
Time frame: baseline, 7 to 10 days and 21 to 30 days
Gram Stain Nugent Score
Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution
Time frame: baseline, 7 to 10 days and 21 to 30 days
Saline wet mount for clue cells
Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution
Time frame: baseline, 7 to 10 days and 21 to 30 days
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Lumara Health, Inc.