Vaginal Clindamycin Cream Plus Vaginal Probiotic for Bacterial Vaginosis

August 5, 2018 updated by: IBRAHIM ABD ELGAFOR, Zagazig University

Continuous Versus Interrupted Use.of Vaginal Probiotic Plus Vaginal Clindamycin Cream for Bacterial Vaginosis a Randomized Controlled Study

Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Vaginal Clindamycin Cream was used initially for treatment of Bacterial Vaginosis followed by Vaginal probiotic either in cnotinous or interrupted manner, then assessment of the results of treatment at different time intervals was done.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Recruiting
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • more than 18 years
  • has recurrent Bacterial Vaginosis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic
Vaginal Clindamycin Cream followed by continuous Vaginal Probiotic use for 60 days
Drug: Vaginal Clindamycin Cream
Vaginal Clindamycin Cream
Other Names:
  • dalacin c cream
Drug: Vaginal Probiotic
Vaginal Probiotic
Other Names:
  • dicoflor vaginal capsules
Active Comparator: Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic
Vaginal Clindamycin Cream followed by interrupted Vaginal Probiotic use
Drug: Vaginal Clindamycin Cream
Vaginal Clindamycin Cream
Other Names:
  • dalacin c cream
Drug: Vaginal Probiotic
Vaginal Probiotic
Other Names:
  • dicoflor vaginal capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
initial cure rate
Time Frame: 2 months
number of women completely cured
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence rate
Time Frame: 4,6,8and12 months
number of women had recurrence
4,6,8and12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Ibrahim A EL sharkwy, FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

July 26, 2017

First Submitted That Met QC Criteria

July 26, 2017

First Posted (Actual)

July 31, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 5, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zuh- 8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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