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Efficacy of Multi-Gyn ActiGel for treatment of vaginal infections

The efficacy of Multi-Gyn ActiGel as a first-line treatment for vaginal discomforts; a double blind, placebo controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22559
Enrollment
140
Registered
2015-09-18
Start date
2015-09-23
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal discomforts

Interventions

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 ex

Sponsors

Sponsor: BioClin BV, Delft, The Netherlands Performer: Dr. Unnop Jaisamrarn Associate Professor Dept. of Obstetrics and Gynecology Faculty of Medicine Chulalongkorn University Bangkok, Thailand
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Women suffering from a vaginal infection • Age between 18 and 60 years

Exclusion criteria

Exclusion criteria: • Women with a a sexually transmitted disease • Pregnancy or planned pregnancy during the study period

Design outcomes

Primary

MeasureTime frame
- Clinical cure of vaginal infection as diagnosed by the investigator - Reduction in severity of patient vaginal complaints

Secondary

MeasureTime frame
- 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)

Contacts

Public ContactPaul Kwakman

BioClin BV

p.kwakman@bioclin.com+31 15 251 2896

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)