Trial Outcomes & Findings for A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations (NCT NCT01039584)

Last Updated: 2023-07-12

Results Overview

Therapeutic cure is defined as both the mycologically-proven eradication of infection caused by Candida species (mycological cure) and evidence of clinical success (clinical cure)

Recruitment status

COMPLETED

Study phase

Target enrollment

611 participants

Primary outcome timeframe

Visit 3: Day 22-31

Results posted on

2023-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Test Product Butoconazole Nitrate Vaginal Cream Butoconazole Nitrate Vaginal Cream : vaginal cream	Reference Product Gynazole 1 Vaginal Cream Gynazole 1 vaginal cream : vaginal cream	Placebo vehicle of the test product Placebo : vaginal cream
Overall Study STARTED	246	243	122
Overall Study COMPLETED	143	146	65
Overall Study NOT COMPLETED	103	97	57

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Product Butoconazole Nitrate Vaginal Cream Butoconazole Nitrate Vaginal Cream : vaginal cream	Reference Product Gynazole 1 Vaginal Cream Gynazole 1 vaginal cream : vaginal cream	Placebo vehicle of the test product Placebo : vaginal cream
Overall Study Withdrawal by Subject	4	2	1
Overall Study Protocol Violation	10	4	6
Overall Study Lost to Follow-up	5	3	4
Overall Study Negative Baseline culture for Candida	59	59	24
Overall Study Lack of Efficacy	7	6	10
Overall Study other	1	3	1
Overall Study Pap smear with significant pathology	10	10	3
Overall Study Positive for Chlamydia or gonorrhea	7	10	8

Baseline Characteristics

A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Product n=246 Participants Butoconazole Nitrate Vaginal Cream Butoconazole Nitrate Vaginal Cream : vaginal cream	Reference Product n=243 Participants Gynazole 1 Vaginal Cream Gynazole 1 vaginal cream : vaginal cream	Placebo n=122 Participants vehicle of the test product Placebo : vaginal cream	Total n=611 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	236 Participants n=5 Participants	238 Participants n=7 Participants	117 Participants n=5 Participants	591 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Age, Continuous	32.1 years STANDARD_DEVIATION 10.29 • n=5 Participants	32.1 years STANDARD_DEVIATION 10.02 • n=7 Participants	33.3 years STANDARD_DEVIATION 11.15 • n=5 Participants	32.3 years STANDARD_DEVIATION 10.35 • n=4 Participants
Sex: Female, Male Female	246 Participants n=5 Participants	243 Participants n=7 Participants	122 Participants n=5 Participants	611 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	108 participants n=5 Participants	107 participants n=7 Participants	54 participants n=5 Participants	269 participants n=4 Participants
Region of Enrollment Central America	54 participants n=5 Participants	53 participants n=7 Participants	26 participants n=5 Participants	133 participants n=4 Participants
Region of Enrollment South America	84 participants n=5 Participants	83 participants n=7 Participants	42 participants n=5 Participants	209 participants n=4 Participants

PRIMARY outcome

Timeframe: Visit 3: Day 22-31

Population: per-protocol

Therapeutic cure is defined as both the mycologically-proven eradication of infection caused by Candida species (mycological cure) and evidence of clinical success (clinical cure)

Outcome measures

Outcome measures
Measure	Test Product n=137 Participants Butoconazole Nitrate Vaginal Cream Butoconazole Nitrate Vaginal Cream : vaginal cream	Reference Product n=133 Participants Gynazole 1 Vaginal Cream Gynazole 1 vaginal cream : vaginal cream	Placebo n=67 Participants vehicle of the test product Placebo : vaginal cream
The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure.	73 participants	73 participants	16 participants

SECONDARY outcome

Timeframe: Visit 3: Day 22-31

Population: per-protocol

Clinical cure (clinical success) was defined as follows: 1. All signs or symptoms with a score of 1 (mild) or 2 (moderate) at Visit 1/Baseline had a score of 0 (absent) at Visit 3/Test-of-Cure, or all signs or symptoms with a score of 3 (severe) at Visit 1/Baseline had a score of 0 (absent) or 1 (mild) at Visit 3/Test-of-Cure 2. A new sign or symptoms was observed at Visit 3/Test-of-Cure that was not present at entry and was determined by the investigator to not be related to VVC (if related, the subject was considered a failure; if not related, the subject could have been considered a cure) 3. The subject did not require additional vulvovaginal or systemic antifungal therapy 4. 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 analgesics or corticosteroid products

Outcome measures

Outcome measures
Measure	Test Product n=137 Participants Butoconazole Nitrate Vaginal Cream Butoconazole Nitrate Vaginal Cream : vaginal cream	Reference Product n=133 Participants Gynazole 1 Vaginal Cream Gynazole 1 vaginal cream : vaginal cream	Placebo n=67 Participants vehicle of the test product Placebo : vaginal cream
Clinical Cure	91 participants	92 participants	32 participants

SECONDARY outcome

Timeframe: Visit 3: Day 22-31

Mycological cure was defined as a negative mycological culture (no growth)

Outcome measures

Outcome measures
Measure	Test Product n=137 Participants Butoconazole Nitrate Vaginal Cream Butoconazole Nitrate Vaginal Cream : vaginal cream	Reference Product n=133 Participants Gynazole 1 Vaginal Cream Gynazole 1 vaginal cream : vaginal cream	Placebo n=67 Participants vehicle of the test product Placebo : vaginal cream
Mycological Cure	83 participants	79 participants	18 participants

Adverse Events

Test Product

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reference Product

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Schwartz

Perrigo

Phone: 718-960-9900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER