Multi-Center Study of New Medications to Treat Vaginal Infections

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Curatek Pharmaceuticals, LLC
• Treatments: Metronidazole; Terconazole

Criteria

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