Multi-Center Study of New Medications to Treat Vaginal Infections

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of terconazole gel in the treatment of vaginal infections

Official Title
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Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety

Conditions
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Vaginal Infection

Intervention / Treatment
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* Drug: Terconazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and: Capable of providing written informed consent or assent Currently not menstruating and not anticipating menses during treatment If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically sterile, or practicing an acceptable form of birth control Negative pregnancy test Other criteria as identified in the protocol Exclusion Criteria: Other infectious causes of vulvovaginitis Subject has recently used, or is expected to require the concomitant use of prohibited medications/products Nursing mother Use of any investigational drug within 30 days of enrollment History of hypersensitivity to any ingredient/component of the formulations Other criteria as identified in the protocol

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Terconazole vaginal gel<br>One applicator full at bedtime | Drug: Terconazole<br> <br> |
| Placebo Comparator: Gel vehicle<br>One applicator full at bedtime | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit | The percentage of participants with clinical cure in each arm was compared. A clinical cure is defined as the resolution of all signs and symptoms attributable to vulvovaginal candidiasis | 7-14 days after beginning treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection | Signs (edema, erythema, excoriation) and symptoms (itching, burning irritation) were each scored as absent (0), mild (1), moderate (2) or severe (3). A total sign score of 0-9 and total symptom score of 0-9 were combined for a total possible combined sign and symptom score of 0-18. Total median combined sign and symptom severity score was compared between arms at the test of cure visit. Lower scores at day 7-14 indicate improvement. | 7-14 days after beginning treatment | 
| Mycologic Cure | Vaginal swabs were cultured for Candida species in a laboratory. A positive culture indicates presence of vaginal yeast and a negative culture indicates absence of vaginal yeast. A negative culture indicates mycologic cure. | 7-14 days after beginning treatment and at 21-30 days after beginning treatment | 
| Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit | Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms. | 7-14 days after beginning treatment | 
| Number of Participants With Treatment Emergent Adverse Events | Adverse events were collected at study visits, from subject diaries and from spontaneous reports | Any time during study participation (up to 30 days) |