No registrations found.
ID
Source
Health condition
Vaginal discomforts; bacterial vaginosis; vaginal yeast infection; candidiasis
Sponsors and support
Performer:
Dr. Unnop Jaisamrarn
Associate Professor
Dept. of Obstetrics and Gynecology
Faculty of Medicine
Chulalongkorn University
Bangkok, Thailand
Intervention
Outcome measures
Primary outcome
- Clinical cure of vaginal infection as diagnosed by the investigator
- Reduction in severity of patient vaginal complaints
Secondary outcome
- Clinical cure of vaginosis as diagnosed by the investigator
- Reduction in severity of vaginitis as observed by the investigator
- Reduction in severity of specific symptoms of vaginal discomforts, i.e. relief of itch, discharge, malodor, burning, pain
- Subgroup analysis for improvement of microscopic evaluations (Nugent score, yeast cells, granulocytes)
Background summary
Many women suffer from vaginal infections (mostly candidiasis or bacterial vaginosis) and associated complaints such as itch, malodor and abnormal discharge. Although these conditions hardly ever have serious medical consequences, they can severele affect the quality of life of women that suffer from these conditions. Standard treatment of vaginal infections consists of antibiotic or antimycotic therapy, but these drugs have several side-effects and also recurrence rates are very high. Multi-Gyn ActiGel is a natural alternative to antimicrobial agents that contains patented anti-adhesive polysaccharides (called 2QR-complex) to correct the healthy vaginal microflora. In this study we aim to assess the efficacy of ActiGel over a placebo gel to treat vaginal infections and the associated complaints. Multi-Gyn ActiGel is a substance-based medical device class IIa.
Study objective
Multi-Gyn ActiGel is effective to treat vaginal infections and relief symptoms related to this condition.
Study design
Women will be treated for 5 days, and will return to the gynaecologist between day 5-8 from the start of treatment
Intervention
Women that present themselves with a vaginal infection at the gyneacologist will use Multi-Gyn ActiGel or placebo for 5 days, twice per day. At study entry and at follow up women will be physically examined, and a vaginal swab will be obtained for microscopy, cytology and pH measurement.
Paul Kwakman
Delftechpark 55
Delft 2628 XJ
The Netherlands
+31 15 251 2896
p.kwakman@bioclin.com
Paul Kwakman
Delftechpark 55
Delft 2628 XJ
The Netherlands
+31 15 251 2896
p.kwakman@bioclin.com
Inclusion criteria
• Women suffering from a vaginal infection
• Age between 18 and 60 years
Exclusion criteria
• Women with a a sexually transmitted disease
• Pregnancy or planned pregnancy during the study period
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5331 |
| NTR-old | NTR5440 |
| Other | 221/56 : IRB Chulalongkorn University |