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 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: Metronidazole
* Drug: Gel vehicle


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: Metronidazole vaginal gel<br>One applicator full at bedtime | Drug: Metronidazole<br> <br> |
| Placebo Comparator: Gel vehicle<br>One applicator full at bedtime | Drug: Gel vehicle<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. Clinical cure of bacterial vaginosis is 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of BV Clue Cells | Clue cells on wet mount were assessed and categorized as absent (<20%) or present (>=20%). Absence of clue cells is associated with improvement. The comparison was for percentage between arms for clue cells absent (<20%). | 7-14 days after beginning treatment | 
| Microbiologic Improvement/Cure | For bacterial vaginosis (BV), Gram stain Nugent scores are catergized as normal (0 to 3), intermediate (4 to 6) or BV (7 to 10). Normal scores are associated with BV microbiologic cure. The percentage of participants with normal scores were compared between treatments. | 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) |