NCT03234517

Brief Summary

Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis

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
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2016

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

Study Start

First participant enrolled

August 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 7, 2018

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

July 26, 2017

Last Update Submit

August 5, 2018

Conditions

Bacterial Vaginosis Treatment

Outcome Measures

Primary Outcomes (1)

  • initial cure rate

    number of women completely cured

    2 months

Secondary Outcomes (1)

  • recurrence rate

    4,6,8and12 months

Study Arms (2)

Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic

EXPERIMENTAL

Vaginal Clindamycin Cream followed by continuous Vaginal Probiotic use for 60 days

Drug: Vaginal Clindamycin CreamDrug: Vaginal Probiotic

Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic

ACTIVE COMPARATOR

Vaginal Clindamycin Cream followed by interrupted Vaginal Probiotic use

Drug: Vaginal Clindamycin CreamDrug: Vaginal Probiotic

Interventions

Vaginal Clindamycin CreamDRUG

Vaginal Clindamycin Cream

Also known as: dalacin c cream
Vaginal Clindamycin Cream Plus continuous Vaginal ProbioticVaginal Clindamycin Cream Plus interrupted Vaginal Probiotic
Vaginal ProbioticDRUG

Vaginal Probiotic

Also known as: dicoflor vaginal capsules
Vaginal Clindamycin Cream Plus continuous Vaginal ProbioticVaginal Clindamycin Cream Plus interrupted Vaginal Probiotic

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • more than 18 years
  • has recurrent Bacterial Vaginosis

You may not qualify if:

  • pregnancy
  • use of other antmicrobial
  • not provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, Egypt

RECRUITING

Study Officials

  • Ibrahim A EL sharkwy

    FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ibrahim A EL sharkwy

CONTACT

00966554818576ibrahimsharkwy@yahoo.com

Mohamed L Elsayed

CONTACT

00201222442467drmohamedlotfy@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 31, 2017

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 7, 2018

Record last verified: 2017-07

Locations

EG(1)