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/metronidazole 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: Metronidazole
* Drug: Terconazole/metronidazole


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> |
| Active Comparator: Metronidazole vaginal gel<br>One applicator full at bedtime | Drug: Metronidazole<br> <br> |
| Active Comparator: Terconazole/metronidazole vaginal gel<br>One applicator full at bedtime | Drug: Terconazole/metronidazole<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit | The percentage of participants with clinical cure of both bacterial vaginosis (BV) AND vulvovaginal candidiasis (VVC) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV is defined as: discharge has returned to normal/physiologic, negative whiff test, and saline wet mount is <20% clue cells. Clinical cure of VVC is defined as 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 |
| --- | --- | --- |
| Cure of the BV Component of Mixed Infection | The percentage of participants with both BV and VVC who had clinical cure of bacterial vaginosis (BV) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV was defined as: 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine fishy odor, 3. the saline wet mount is <20% clue cells | 7-14 days after beginning treatment | 
| Cure of the VVC Component of Mixed Infection | The percentage of participants with both BV and VVC who had clinical cure of VVC was compared between the combination therapy and the two single entity treatments.Clinical cure of VVC was defined as complete resolution of all signs and symptoms attributable to VVC | 7-14 days after beginning treatment | 
| Microbiologic and Mycologic Cure | The percentage of participants with both microbiologic and mycologic cure was compared between the combination therapy and the two single entity treatments. Yeast cultures were performed and Gram stains of vaginal fluid were graded according to Nugent's criteria. Microbiologic cure requires normal Nugent gram stain score and mycologic cure requires negative yeast culture. | 7-14 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) |