Multi-Center Study of New Medications to Treat Vaginal Infections

Curatek Pharmaceuticals, LLC204 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the treatment of vaginal infections.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

204

Conditions

Vaginal Infection

Interventions

MetronidazoleDRUG

Gel vehicleDRUG

Eligibility

Sex: FEMALEMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (35)

Outcomes

Primary Outcomes

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

Time frame: 7-14 days after beginning treatment

Secondary Outcomes

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%).

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: Any time during study participation (up to 30 days)

Data from ClinicalTrials.gov

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