Overview

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