Observational Program Neo-Penotran® Forte

Completed

• Conditions: Vaginal Candidiasis; Bacterial Vaginosis; Trichomonal Vaginitis
• Interventions: Drug: Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276)

• Registration Number: NCT01335373
• Lead Sponsor: Bayer

Brief Summary

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

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Primary Completion: 2011-12
• Study Completion: 2015-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-07-22
• Last Update Posted: 2016-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13024

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.

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Exclusion Criteria

• Presence of contraindications according to package insert.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276)	-

Primary Outcome Measures

Name	Time	Method
Percent rate of different vaginal infections	Approximately within 6 months after the last patient last visit.

Secondary Outcome Measures

Name	Time	Method
Clinical characteristics of vaginitis after treatment.	Depending on treatment time chosen by the physician, after 7 or 14 days.
Change of microbiological characteristics after treatment	Depending on treatment time chosen by the physician, after 7 or 14 days.
Patient rating of tolerability and treatment results	Depending on treatment time chosen by the physician, after 7 or 14 days.
Physician's rating of tolerability and treatment results	Depending on treatment time chosen by the physician, after 7 or 14 days.