NCT04057482

Brief Summary

. Treatment with dequalinium chloride vaginal tablets for 6 days had a cure rate lower than expected; only 37% of patients were considered cured one month after treatment.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

2.6 years

First QC Date

August 12, 2019

Last Update Submit

August 14, 2019

Conditions

Bacterial Vaginoses

Keywords

Bacterial vaginosis, polymerase chain reaction, molecular diagnostic

Outcome Measures

Primary Outcomes (1)

  • cure rate of BV

    how many that are cured of BV after 1 month

    1 year

Secondary Outcomes (1)

  • Diagnosis of BV using molecular test

    1 year

Interventions

DDRUG

treatment of BV with dequalinium chloride vaginal tablets

Also known as: dequalinium chloride vaginal tablets

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

local maternity and youth clinics in Skaraborg county

You may not qualify if:

  • No other infection (Gc, clhlamydia, trihomonas)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: NONE RETAINED

Molecu

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Fumigant 93

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • P-G Larsson, PhD

    överläkare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 15, 2019

Study Start

May 1, 2015

Primary Completion

December 1, 2017

Study Completion

April 1, 2018

Last Updated

August 15, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share