NCT04067531

Brief Summary

Treatment of BV with first deqularum cloride and then followed with clindamycin vaginal Cream.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 19, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 27, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

August 19, 2019

Last Update Submit

October 24, 2020

Conditions

Infection, Bacterial

Outcome Measures

Primary Outcomes (1)

  • cure of BV

    cure rate of BV

    6 month

Study Arms (1)

treatment of BV

OTHER

all patients be treated with first Deqularum then with clindamycin Cream,

Drug: treatment of BV with first Deqularum and then direkt after with vaginal clindamycin

Interventions

treatment of BV with first Deqularum and then direkt after with vaginal clindamycinDRUG

All patients will get the same treatment

treatment of BV

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • healthy women with BV

You may not qualify if:

  • women treated with antibiotics within 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ob/Gyn, Skaraborgshospital Skövde

Skövde, 541 85, Sweden

RECRUITING

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • P-G Larsson

    professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

P-G Larsson

CONTACT

+46500431000p-g.larsson@vgregion.se

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 19, 2019

First Posted

August 26, 2019

Study Start

August 1, 2020

Primary Completion

August 1, 2021

Study Completion

December 1, 2021

Last Updated

October 27, 2020

Record last verified: 2020-03

Locations

SE(1)