Multi-Center Study of New Medications to Treat Vaginal Infections (SMART GIVES)

Curatek Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Vaginal Infection

Treatments: Drug: Terconazole/metronidazole; Drug: Terconazole; Drug: Metronidazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02308007

MTC-001 (Trial 3)

Details and patient eligibility

About

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

Enrollment: 475 patients

Sex: Female

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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475 participants in 3 patient groups

Terconazole vaginal gel

Active Comparator group

Description:

One applicator full at bedtime

Treatment:

Drug: Terconazole

Metronidazole vaginal gel

Active Comparator group

Description:

One applicator full at bedtime

Treatment:

Drug: Metronidazole

Terconazole/metronidazole vaginal gel

Active Comparator group

Description:

One applicator full at bedtime

Treatment:

Drug: Terconazole/metronidazole