Title
Multi-Center Study of New Medications to Treat Vaginal Infections
Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety
Phase
Phase 3Lead Sponsor
Curatek PharmaceuticalsStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Vaginal InfectionIntervention/Treatment
metronidazole ...Study Participants
204The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the treatment of vaginal infections.
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
| Event Type | Organ System | Event Term | Metronidazole Vaginal Gel | Gel Vehicle |
|---|
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
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%).
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.
Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms.
Adverse events were collected at study visits, from subject diaries and from spontaneous reports
