A Phase 3 interventional study of Product 55394 and Placebo Vehicle (non-treatment) in Bacterial Vaginosis, sponsored by Medicis Global Service Corporation. Completed at 37 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-21.
Sponsored by Medicis Global Service Corporation · Phase 3, Interventional, and Treatment
The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.
220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.
This study's enrollment of 651 is above the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Medicis Global Service Corporation is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with the vehicle (placebo)
Drug: Placebo Vehicle (non-treatment)
Treatment with product 55394
Drug: Product 55394
Product 55394 vaginal gel in a prefilled applicator.
The vehicle vaginal gel in an applicator (placebo).
Clinical Cure
The proportion of subjects with a clinical cure at the Day 21 visit, as assessed by the investigator.
Time frame: Day 21
Therapeutic Cure
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.
Time frame: Day 21
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Medicis Global Service Corporation