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van CCT (UK)

van CCT (UK)

Efficacy of Multi-Gyn ActiGel for treatment of vaginal infections

- candidate number22890
- NTR NumberNTR5440
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-sep-2015
- Secondary IDsIRB Chulalongkorn University 221/56
- Public TitleEfficacy of Multi-Gyn ActiGel for treatment of vaginal infections
- Scientific TitleThe efficacy of Multi-Gyn ActiGel as a first-line treatment for vaginal discomforts; a double blind, placebo controlled study
- hypothesisMulti-Gyn ActiGel is effective to treat vaginal infections and relief symptoms related to this condition.
- Healt Condition(s) or Problem(s) studiedCandida albicans, Bacterial vaginosis
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-sep-2015
- planned closingdate31-jul-2016
- Target number of participants140
- InterventionsWomen 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.
- Primary outcomeClinical cure of vaginal infection as diagnosed by the investigator
- Secondary outcomeReduction in symptoms of vaginal infection as experienced by the patient, i.e. relief of itch, discharge, malodor, burning, pain

Laboratory parameters (e.g. absence of Amsel criteria, Nugent score <3, absence of yeast in microscopy)
- TimepointsWomen will be treated for 5 days, and will return to the gynaecologist between day 5-8 from the start of treatment
- Trial web site
- statusinclusion stopped: follow-up
- Sponsor/Initiator BioClin BV, Dr. Unnop Jaisamrarn - Chulalongkorn University, Faculty of Medicine
- Funding
(Source(s) of Monetary or Material Support)
Bioclin BV
- Publications
- Brief summaryMany 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.
- Main changes (audit trail)4-jun-2016:
Primary outcome NEW:
- Reduction in severity of patient vaginal complaints

Secondary outcomes:
- 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)
- RECORD18-sep-2015 - 4-jun-2016

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