Observational Program Neo-Penotran® Forte

NCT ID: NCT01335373

Last Updated: 2016-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13024 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-04-30

Brief Summary

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Vaginitis is the most common gynecologic diagnosis in the primary care setting. In approximately 90 percent of affected women, this condition occurs secondary to bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis or mixed infection.

Neo-Penotran Forte is registered for treatment of these most common vaginal infections. Efficacy and safety of this product is already established, and this observational study was designed to learn more about practical use of Neo-Penotran® Forte in real life setting.

Detailed Description

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Conditions

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Vaginal Candidiasis Bacterial Vaginosis Trichomonal Vaginitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276)

Intervention Type DRUG

Patients older than 18 years with previously taken decision of their gynecologist to prescribe Neo-Penotran Forte according to registered indications, and microbiological tests were performed.

Interventions

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Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276)

Patients older than 18 years with previously taken decision of their gynecologist to prescribe Neo-Penotran Forte according to registered indications, and microbiological tests were performed.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients older than 18 years with previously taken decision of their gynecologist to prescribe Neo-Penotran Forte according to registered indications, and microbiological tests were performed.

Exclusion Criteria

* Presence of contraindications according to package insert.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Kazakhstan

Site Status

Countries

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Kazakhstan

Other Identifiers

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NP1010KZ

Identifier Type: OTHER

Identifier Source: secondary_id

15511

Identifier Type: -

Identifier Source: org_study_id

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