## Protocol Section
### Identification Module
**NCT ID:** NCT00556179

**Brief Title:** Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis

**Official Title:** Local, National (Brazil), Multicentric, Open, Non-Controlled, Phase IV, Study of Lactoserum (Dermacyd Femina®), in Women at Reproductive Age, to Prevent Recurrence of Bacterial Vaginosis, During Three Months, After Standard Treatment With Metronidazole.

#### Organization Study ID Info
**ID:** LACTO_L_02399
#### Organization
**Class:** INDUSTRY
**Full Name:** Sanofi
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2009-01-22

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-01-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-12

**Type:** ACTUAL

#### Start Date
**Date:** 2007-09

**Status Verified Date:** 2009-01

#### Study First Post Date
**Date:** 2007-11-09
**Type:** ESTIMATED
**Study First Submit Date:** 2007-11-08
**Study First Submit QC Date:** 2007-11-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sanofi

#### Responsible Party

**Old Name Title:** Medical Affairs Study Director

**Old Organization:** sanofi-aventis

### 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.

### Conditions Module

**Conditions:**

- Bacterial Vaginosis

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 122

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Lactoserum (Dermacyd Femina®)

**Label:** 1

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** Once a day during three months

**Name:** Lactoserum (Dermacyd Femina®)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Rate of recurrence of bacterial vaginosis after three months of treatment.

**Time Frame:** Three months

#### Secondary Outcomes

**Measure:** Quality of life

**Time Frame:** Three months

**Measure:** Vaginal Candidiasis

**Time Frame:** Three months

**Measure:** AE, particularly genital irritation (tolerability use of dermacyd)

**Time Frame:** During the study

### 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.

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** São Paulo

**Country:** Brazil

**Facility:** Sanofi-aventis

#### Overall Officials

**Official 1:**

**Affiliation:** Sanofi-aventis administrative office Brazil

**Name:** Jaderson Lima

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000007239

- Term: Infections

- ID: D000014627

- Term: Vaginitis

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M14850

- Name: Recurrence

- Relevance: HIGH

- As Found: Recurrence

- ID: M18971

- Name: Vaginosis, Bacterial

- Relevance: HIGH

- As Found: Bacterial Vaginosis

- ID: M17371

- Name: Vaginal Diseases

- Relevance: HIGH

- As Found: Vaginosis

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M17375

- Name: Vaginitis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016585

- Term: Vaginosis, Bacterial

- ID: D000014623

- Term: Vaginal Diseases

- ID: D000012008

- Term: Recurrence

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11767

- Name: Metronidazole

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
