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Single Arm Study of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

NCT05211921 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-08-18

No results posted yet for this study

Summary

Open, single arm trial that intends to confirm the safety and efficacy of Multi-Gyn ActiGel Plus for treatment of Bacterial Vaginosis. Adult women will be diagnosed by the gynaecologist based on the Amsel criteria at day 0. They will use the product for 7 days and will come to the practice at day 21. The primary endpoint is the clinical cure rate of Bacterial Vaginosis at 3 weeks after start of treatment.

Conditions

  • Bacterial Vaginosis

Interventions

DEVICE

Multi-Gyn ActiGel Plus

vaginal gel

Sponsors & Collaborators

  • Karo Pharma AB

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2022-05-11
Completion
2022-05-11

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05211921 on ClinicalTrials.gov