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

Vulvovaginal Candidiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803738
• Other study ID #: CPL-202
• Status: Completed
• Phase: N/A
• Start date: December 2002
• Est. completion date: December 2003

Study information

• Verified date: October 2021
• Source: Padagis LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 572
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiasis

Intervention

Drug:
• Terconazole Vaginal Suppository
Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days
• Terazol Vaginal Suppository
Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Padagis LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of Subjects With Mycological Cure	Mycological cure was defined as a negative mycological culture (no growth) for Candida albicans or other relevant baseline yeast organism.	Visit 3: Day 22-31
Secondary	Proportion of Subjects With Clinical Cure	A subject was considered a clinical cure if all of the following were satisfied: 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.; Total signs and symptoms did not worsen at any time following completion of the study treatment.; Any new sign or symptom observed during the study period was determined by the Investigator not to be related to VVC.; The subject did not require additional vulvovaginal or systemic antifungal therapy at any time during the study period.; 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	Visit 3: Day 22-31