Lactoserum (Dermacyd Femina®) and Prevention of Recurrenc... | NCT00556179

Studies
Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis

NCT00556179

Sponsor

Sanofi

Status

Completed

Last Update Posted

Jan 22, 2009Estimated

Enrollment

122Actual

Phase

Phase 4

Conditions

Bacterial Vaginosis

Interventions

Lactoserum (Dermacyd Femina®)

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Not provided

First Submitted Date

Nov 8, 2007

First Submission Date that Met QC Criteria

Nov 8, 2007

First Posted Date

Nov 9, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2009

Last Update Posted Date

Jan 22, 2009Estimated

Description Module

Brief Summary

The purpose of this study is to demonstrate if the use of Dermacyd can avoid the recurrence of bacterial vaginosis after three months of the standard treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

122Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Lactoserum (Dermacyd Femina®)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lactoserum (Dermacyd Femina®)	Drug	Once a day during three months	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of recurrence of bacterial vaginosis after three months of treatment.		Three months

Secondary Outcomes

Measure	Description	Time Frame
Quality of life		Three months
Vaginal Candidiasis		Three months
AE, particularly genital irritation (tolerability use of dermacyd)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women in reproductive age
Confirmed cure of bacterial vaginosis after treatment with oral metronidazole.
Vaginal bacterioscopic examination negative for candida and trichomonas.

Exclusion Criteria:

Pregnant or breastfeeding women
Allergy to dermacyd

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaderson Lima	Sanofi-aventis administrative office Brazil	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-aventis		São Paulo	São Paulo		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D016585	Vaginosis, Bacterial

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D014627	Vaginitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C018577	lactoserum

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided