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

Purpose

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.

Condition	Intervention
Vulvovaginal Candidiasis	Drug: Terconazole Vaginal Suppository Drug: Terazol Vaginal Suppository


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	A Multi-center, Randomized, Investigator-blinded, Parallel-group Study, Designed to Evaluate the Safety and Clinical Equivalence of Terconazole Vaginal Suppositories, 80 mg (Test Product) and Terconazole Vaginal Suppositories, 80 mg (Reference Product) in the Treatment of Vulvovaginal Candidiasis Caused by Candida Species

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections

Drug Information available for: Terconazole

U.S. FDA Resources

Further study details as provided by Perrigo Company:

Primary Outcome Measures:

Proportion of Subjects in Each Treatment Group With Therapeutic Cure [ Time Frame: Visit 3: Day 22-31 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Proportion of Subjects With Mycological Cure [ Time Frame: Visit 3: Day 22-31 ] [ Designated as safety issue: No ]
Mycological cure was defined as a negative mycological culture (no growth) for Candida albicans or other relevant baseline yeast organism.
Proportion of Subjects With Clinical Cure [ Time Frame: Visit 3: Day 22-31 ] [ Designated as safety issue: No ]
A subject was considered a clinical cure if all of the following were satisfied:
1. All signs and symptoms with a score of 1 (mild) or 2 (moderate) at the Screening/Baseline visit were absent (score = 0), and all signs or symptoms with a score of 3 (severe) at Screening/Baseline had a score of 0 or 1.
2. Total signs and symptoms did not worsen at any time following completion of the study treatment.
3. Any new sign or symptom observed during the study period was determined by the Investigator not to be related to VVC.
4. The subject did not require additional vulvovaginal or systemic antifungal therapy at any time during the study period.
5. The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus such as topical analgesic or corticosteroid products


Enrollment:	572
Study Start Date:	December 2002
Study Completion Date:	December 2003
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Test Product Terconazole Vaginal Suppository	Drug: Terconazole Vaginal Suppository Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days
Active Comparator: Reference Product Terazol Vaginal Suppository	Drug: Terazol Vaginal Suppository Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days Other Name: Terazol 3 suppository

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information


Responsible Party:	Perrigo Company
ClinicalTrials.gov Identifier:	NCT00803738 History of Changes
Other Study ID Numbers:	CPL-202
Study First Received:	December 5, 2008
Results First Received:	May 11, 2012
Last Updated:	January 17, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Perrigo Company:


Vulvovaginal Candidiasis Terconazole

Additional relevant MeSH terms:


Candidiasis Candidiasis, Vulvovaginal Mycoses Vulvovaginitis Vaginitis Vaginal Diseases	Genital Diseases, Female Vulvitis Vulvar Diseases Terconazole Antifungal Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 29, 2016