Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis

Padagis

Status

Completed

Conditions

Vulvovaginal Candidiasis

Treatments

Drug: Terazol Vaginal Suppository

Drug: Terconazole Vaginal Suppository

Study type

Interventional

Funder types

Industry

Identifiers

NCT00803738

CPL-202

Details and patient eligibility

About

The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order to establish bioequivalence.

Enrollment

572 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female at least 18 years of age
Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
Willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol.

Exclusion criteria

History of hypersensitivity or allergy to imidazoles
Female who was pregnant or lactating
Was menstruating or expected the onset of menses during the treatment days
Had evidence of any bacterial, viral or protozoal infection
Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
Had participated in any investigational study within 30 days prior to study enrollment