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

• Sponsor: Padagis LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01039584
• Collaborator: (none)
• Enrollment: 611
• Location: 1
• Arms: 3
• Duration (Months): 22
• Patients Per Site Per Month: 27.8

Study Details

Study Description

Brief Summary

This was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of vulvovaginal candidiasis caused by Candida species.

Condition or Disease	Intervention/Treatment	Phase
Vulvovaginal Candidiasis	Drug: Butoconazole Nitrate Vaginal Cream; Drug: Placebo; Drug: Gynazole 1 vaginal cream	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 611 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: A Randomized Study Evaluating the Therapeutic Equivalence and Safety of Butoconazole Nitrate Vaginal Cream, 2% and Gynazole 1 (Butoconazole Nitrate) Vaginal Cream, 2%, Against a Vehicle Control in the Treatment of Vulvovaginal Candidiasis
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo vehicle of the test product; applied intravaginally once within 48 hours of randomization	Drug: Placebo; vaginal cream; Other Names: vehicle of the test product
Experimental: Test Product Butoconazole Nitrate Vaginal Cream; applied intravaginally once within 48 hours of randomization	Drug: Butoconazole Nitrate Vaginal Cream; vaginal cream
Active Comparator: Reference Product Gynazole 1 Vaginal Cream; applied intravaginally once within 48 hours of randomization	Drug: Gynazole 1 vaginal cream; vaginal cream; Other Names: Gynazole 1

Outcome Measures

Primary Outcome Measures

1. The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure. [Visit 3: Day 22-31]

   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)

Secondary Outcome Measures

1. Clinical Cure [Visit 3: Day 22-31]

   Clinical cure (clinical success) was defined as follows: 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 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) The subject did not require additional vulvovaginal or systemic antifungal therapy 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

2. Mycological Cure [Visit 3: Day 22-31]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Female subjects, at least 18 years of age

• Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis

• Signed and dated informed consent

Exclusion Criteria:

• Were pregnant, nursing, or planning a pregnancy within the study participation period

• Had evidence of any bacterial, viral, or protozoal infection

• Had hypersensitivity or allergy to the imidazoles, their analogues, and/or any of the Test Product ingredients

• Had any medical condition, or used any medication which, in the opinion of the investigator, could have interfered with the conduct of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PharmaNet, Inc. (PharmaNet)	Charlotte	North Carolina	United States	28262

Sponsors and Collaborators

• Padagis LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Padagis LLC
• ClinicalTrials.gov Identifier: NCT01039584
• Other Study ID Numbers: PRG-710
• First Posted: Dec 25, 2009
• Last Update Posted: Oct 13, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by Padagis LLC: bioequivalence; butoconazole; vulvovaginal; candidiasis
• Additional relevant MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Butoconazole

Study Results

Participant Flow

Arm/Group Title	Test Product	Reference Product	Placebo
Arm/Group Description	Butoconazole Nitrate Vaginal Cream Butoconazole Nitrate Vaginal Cream : vaginal cream	Gynazole 1 Vaginal Cream Gynazole 1 vaginal cream : vaginal cream	vehicle of the test product Placebo : vaginal cream
Period Title: Overall Study
STARTED	246	243	122
COMPLETED	143	146	65
NOT COMPLETED	103	97	57

Baseline Characteristics

Arm/Group Title	Test Product	Reference Product	Placebo	Total
Arm/Group Description	Butoconazole Nitrate Vaginal Cream Butoconazole Nitrate Vaginal Cream : vaginal cream	Gynazole 1 Vaginal Cream Gynazole 1 vaginal cream : vaginal cream	vehicle of the test product Placebo : vaginal cream	Total of all reporting groups
Overall Participants	246	243	122	611
Age (Count of Participants)
<=18 years	8 3.3%	5 2.1%	4 3.3%	17 2.8%
Between 18 and 65 years	236 95.9%	238 97.9%	117 95.9%	591 96.7%
>=65 years	2 0.8%	0 0%	1 0.8%	3 0.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.1 (10.29)	32.1 (10.02)	33.3 (11.15)	32.3 (10.35)
Sex: Female, Male (Count of Participants)
Female	246 100%	243 100%	122 100%	611 100%
Male	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	108 43.9%	107 44%	54 44.3%	269 44%
Central America	54 22%	53 21.8%	26 21.3%	133 21.8%
South America	84 34.1%	83 34.2%	42 34.4%	209 34.2%

Outcome Measures

1. Primary Outcome

Title	The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure.
Description	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)
Time Frame	Visit 3: Day 22-31

Outcome Measure Data

Analysis Population Description

per-protocol

Arm/Group Title	Test Product	Reference Product	Placebo
Arm/Group Description	Butoconazole Nitrate Vaginal Cream Butoconazole Nitrate Vaginal Cream : vaginal cream	Gynazole 1 Vaginal Cream Gynazole 1 vaginal cream : vaginal cream	vehicle of the test product Placebo : vaginal cream
Measure Participants	137	133	67
Number [participants]	73 29.7%	73 30%	16 13.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Product, Reference Product
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	The primary efficacy measure was the proportion of subjects with therapeutic cure at Visit 3/Test-of-Cure. Therapeutic cure was defined as having both a mycological cure and a clinical cure.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Yates continuity correction
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 90%; -9.1 to 12.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Clinical Cure
Description	Clinical cure (clinical success) was defined as follows: 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 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) The subject did not require additional vulvovaginal or systemic antifungal therapy 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
Time Frame	Visit 3: Day 22-31

Outcome Measure Data

Analysis Population Description

per-protocol

Arm/Group Title	Test Product	Reference Product	Placebo
Arm/Group Description	Butoconazole Nitrate Vaginal Cream Butoconazole Nitrate Vaginal Cream : vaginal cream	Gynazole 1 Vaginal Cream Gynazole 1 vaginal cream : vaginal cream	vehicle of the test product Placebo : vaginal cream
Measure Participants	137	133	67
Number [participants]	91 37%	92 37.9%	32 26.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Product, Reference Product
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	The efficacy measure was the proportion of subjects with clinicl cure at Visit 3/Test-of-Cure.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Yates continuity correction
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 90%; -7.3 to 12.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Mycological Cure
Description	Mycological cure was defined as a negative mycological culture (no growth)
Time Frame	Visit 3: Day 22-31

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Product	Reference Product	Placebo
Arm/Group Description	Butoconazole Nitrate Vaginal Cream Butoconazole Nitrate Vaginal Cream : vaginal cream	Gynazole 1 Vaginal Cream Gynazole 1 vaginal cream : vaginal cream	vehicle of the test product Placebo : vaginal cream
Measure Participants	137	133	67
Number [participants]	83 33.7%	79 32.5%	18 14.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Product, Reference Product
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	The efficacy measure was the proportion of subjects with mycological cure at Visit 3/Test-of-Cure
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Wald's method
	Comments
Method of Estimation	Estimation Parameter	Yates continuity correction
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 90%; -11.7 to 9.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	From the signing of informed consent to 30 days post subject participation.
Arm/Group Title	Test Product		Reference Product		Placebo
Arm/Group Description	Butoconazole Nitrate Vaginal Cream Butoconazole Nitrate Vaginal Cream : vaginal cream		Gynazole 1 Vaginal Cream Gynazole 1 vaginal cream : vaginal cream		vehicle of the test product Placebo : vaginal cream
All Cause Mortality
	Test Product		Reference Product		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Test Product		Reference Product		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/246 (0%)		0/243 (0%)		0/122 (0%)
Other (Not Including Serious) Adverse Events
	Test Product		Reference Product		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/246 (0%)		0/243 (0%)		0/122 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.