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

NCT00803738 | Completed Results

• 1 other identifier: CPL-202
• Study Type: interventional
• Target: 572
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Vulvovaginal Candidiasis

Keywords

Vulvovaginal Candidiasis; Terconazole

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects in Each Treatment Group With Therapeutic Cure

  The primary efficacy measure was the proportion of subjects in each treatment group with a therapeutic cure at the Test-of-Cure visit (Visit 3). A subject was considered a therapeutic cure if the subject was a clinical cure with mycological cure.

  Visit 3: Day 22-31

Secondary Outcomes (2)

• Proportion of Subjects With Mycological Cure

  Visit 3: Day 22-31

• Proportion of Subjects With Clinical Cure

  Visit 3: Day 22-31

Study Arms (2)

Test Product

EXPERIMENTAL

Terconazole Vaginal Suppository

Drug: Terconazole Vaginal Suppository

Reference Product

ACTIVE COMPARATOR

Terazol Vaginal Suppository

Drug: Terazol Vaginal Suppository

Interventions

Terconazole Vaginal Suppository DRUG

Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days

Test Product

Terazol Vaginal Suppository DRUG

Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days

Also known as: Terazol 3 suppository

Reference Product

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Padagis LLC: lead

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Results Point of Contact

• Title: Jonathan Schwartz
• Organization: Perrigo Pharmaceuticals

jonathan.schwartz@perrigo.com

718-960-0119

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 8, 2008
• Study Start: December 1, 2002
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2003
• Last Updated: October 13, 2021
• Results First Posted: February 20, 2013

Record last verified: 2021-10