Observational Program Neo-Penotran® Forte

NCT01335373 — Completed, 13024 participants, Bayer

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Registry	NCT01335373
Status	Completed
Study type	Observational
Enrollment	13024 (Actual)
Sponsor	Bayer (Industry)
Conditions	Vaginal Candidiasis, Bacterial Vaginosis, Trichomonal Vaginitis
Interventions	Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276) (Drug)
Dates	start 2010-10-01, primary completion 2011-12-01, completion 2015-04-01, first posted 2011-04-14, last updated 2016-07-25
Locations	1 site in Kazakhstan

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group 1		Drug: Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276)

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

+Outcome measures

Primary outcomes

Percent rate of different vaginal infections [Approximately within 6 months after the last patient last visit.]

Secondary outcomes

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.]

+Eligibility

Sex: Female, ages: 18 Years to 90 Years

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.

+Locations (1)

Facility	City	Country	Status
	Many Locations	Kazakhstan

+Investigators

Bayer Study Director, Study director, Bayer