Efficacy of Multi-Gyn ActiGel for treatment of vaginal infections

Completed

• Conditions: candidiasis; Vaginal discomforts; bacterial vaginosis; vaginal yeast infection

• Registration Number: NL-OMON22559
• Lead Sponsor: Sponsor: BioClin BV, Delft, The NetherlandsPerformer: Dr. Unnop JaisamrarnAssociate ProfessorDept. of Obstetrics and Gynecology Faculty of MedicineChulalongkorn UniversityBangkok, Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 140

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Clinical cure of vaginal infection as diagnosed by the investigator<br>- Reduction in severity of patient vaginal complaints

Secondary Outcome Measures

Name	Time	Method
- Clinical cure of vaginosis as diagnosed by the investigator<br /><br>- Reduction in severity of vaginitis as observed by the investigator<br /><br>- Reduction in severity of specific symptoms of vaginal discomforts, i.e. relief of itch, discharge, malodor, burning, pain<br /><br>- Subgroup analysis for improvement of microscopic evaluations (Nugent score, yeast cells, granulocytes)