N/A
Completed N=572
Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis
Source: ClinicalTrials.gov NCT00803738 ↗Enrolled (actual)
572
Serious AEs
0.2%
Results posted
Feb 2013
Primary outcomePrimary: Proportion of Subjects in Each Treatment Group With Therapeutic Cure — 105; 93 participants
Summary
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order to establish bioequivalence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects in Each Treatment Group With Therapeutic Cure |
105; 93 | — |
| SECONDARY Proportion of Subjects With Mycological Cure |
127; 117 | — |
| SECONDARY Proportion of Subjects With Clinical Cure |
117; 101 | — |
Eligibility Criteria
Inclusion Criteria
- Female at least 18 years of age
- Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
- Willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol.
Exclusion Criteria
- History of hypersensitivity or allergy to imidazoles
- Female who was pregnant or lactating
- Was menstruating or expected the onset of menses during the treatment days
- Had evidence of any bacterial, viral or protozoal infection
- Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
- Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
- Had participated in any investigational study within 30 days prior to study enrollment
Data sourced from ClinicalTrials.gov (NCT00803738). 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. Informational only — not medical advice.