N/A
N=611
A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations
Vulvovaginal Candidiasis
Bottom Line
View on ClinicalTrials.gov: NCT01039584 ↗Enrolled (actual)
611
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure. — 73; 73; 16 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Butoconazole Nitrate Vaginal Cream (Drug); Placebo (Drug); Gynazole 1 vaginal cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Padagis LLC
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure. |
73; 73; 16 | — |
| SECONDARY Clinical Cure |
91; 92; 32 | — |
| SECONDARY Mycological Cure |
83; 79; 18 | 0.05 |
Summary
This was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of vulvovaginal candidiasis caused by Candida species.
Eligibility Criteria
Inclusion Criteria
- Female subjects, at least 18 years of age
- Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
- Signed and dated informed consent
Exclusion Criteria
- Were pregnant, nursing, or planning a pregnancy within the study participation period
- Had evidence of any bacterial, viral, or protozoal infection
- Had hypersensitivity or allergy to the imidazoles, their analogues, and/or any of the Test Product ingredients
- Had any medical condition, or used any medication which, in the opinion of the investigator, could have interfered with the conduct of the study
Data sourced from ClinicalTrials.gov (NCT01039584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.