Trial Outcomes & Findings for Monthly Itraconazole Versus Classic Homeopathy for Treatment of Recurrent Vulvovaginal Candidiasis (RVVC) (NCT NCT00895453)

NCT ID: NCT00895453

Last Updated: 2016-11-11

Results Overview

candida culture free (monthly vaginal cultures were obtained)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 144 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2016-11-11

Participant Flow

Participant milestones

Measure	Itraconazole itraconazole alone	Itraconazole + Lactobacillus Gasseri itraconazole + local lactobacillus gasseri	Classic Homeopathy
Overall Study STARTED	48	50	46
Overall Study COMPLETED	23	25	23
Overall Study NOT COMPLETED	25	25	23

Reasons for withdrawal

Measure	Itraconazole itraconazole alone	Itraconazole + Lactobacillus Gasseri itraconazole + local lactobacillus gasseri	Classic Homeopathy
Overall Study Lost to Follow-up	25	25	23

Baseline Characteristics

Monthly Itraconazole Versus Classic Homeopathy for Treatment of Recurrent Vulvovaginal Candidiasis (RVVC)

Baseline characteristics by cohort

Measure	Itraconazole n=48 Participants itraconazole alone	Itraconazole + Lactobacillus Gasseri n=50 Participants itraconazole + local lactobacillus gasseri	Classic Homeopathy n=46 Participants	Total n=144 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants	50 Participants n=7 Participants	46 Participants n=5 Participants	144 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	30.5 years STANDARD_DEVIATION 7.8 • n=5 Participants	30.4 years STANDARD_DEVIATION 7.4 • n=7 Participants	30.3 years STANDARD_DEVIATION 8.0 • n=5 Participants	30.4 years STANDARD_DEVIATION 7.4 • n=4 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	50 Participants n=7 Participants	46 Participants n=5 Participants	144 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 Austria	48 participants n=5 Participants	50 participants n=7 Participants	46 participants n=5 Participants	144 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 months

candida culture free (monthly vaginal cultures were obtained)

Outcome measures

Measure	Itraconazole n=23 Participants itraconazole alone	Itraconazole + Lactobacillus Gasseri n=25 Participants itraconazole + local lactobacillus gasseri	Classic Homeopathy n=23 Participants
Candida Culture Free After Maintenance Therapy	18 participants	19 participants	9 participants

Adverse Events

Itraconazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Itraconazole + Lactobacilli Agent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Classic Homeopathy (CH)

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

Armin Witt MD

Vienna Medical School

Phone: +43140400

Email: armin.witt@meduniwien.ac.at

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place