Observational Program Neo-Penotran® Forte
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|ClinicalTrials.gov Identifier: NCT01335373|
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : July 25, 2016
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.
|Condition or disease||Intervention/treatment|
|Vaginal Candidiasis Bacterial Vaginosis Trichomonal Vaginitis||Drug: Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276)|
|Study Type :||Observational|
|Actual Enrollment :||13024 participants|
|Official Title:||Observational Program Neo-Penotran® Forte|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||April 2015|
Drug: 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.
- Percent rate of different vaginal infections [ Time Frame: Approximately within 6 months after the last patient last visit. ]
- Clinical characteristics of vaginitis after treatment. [ Time Frame: Depending on treatment time chosen by the physician, after 7 or 14 days. ]
- Change of microbiological characteristics after treatment [ Time Frame: Depending on treatment time chosen by the physician, after 7 or 14 days. ]
- Patient rating of tolerability and treatment results [ Time Frame: Depending on treatment time chosen by the physician, after 7 or 14 days. ]
- Physician's rating of tolerability and treatment results [ Time Frame: Depending on treatment time chosen by the physician, after 7 or 14 days. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335373
|Many Locations, Kazakhstan|
|Study Director:||Bayer Study Director||Bayer|