Observational Program Neo-Penotran® Forte

Bacterial Vaginosis Clinical Trial

Official title:

Observational Program Neo-Penotran® Forte

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335373
• Other study ID #: 15511
• Secondary ID: NP1010KZ
• Status: Completed
• Phase: N/A
• First received: January 21, 2011
• Last updated: July 22, 2016
• Start date: October 2010
• Est. completion date: April 2015

Study information

• Verified date: May 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kazakhstan: National Center for Expertise of Drugs, Medical Products and Equipment
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13024
• Est. completion date: April 2015
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Candidiasis
• Candidiasis, Vulvovaginal
• Trichomonal Vaginitis
• Trichomonas Vaginitis
• Vaginal Candidiasis
• Vaginal Diseases
• Vaginitis
• Vaginosis, Bacterial

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent rate of different vaginal infections		Approximately within 6 months after the last patient last visit.	No
Secondary	Clinical characteristics of vaginitis after treatment.		Depending on treatment time chosen by the physician, after 7 or 14 days.	No
Secondary	Change of microbiological characteristics after treatment		Depending on treatment time chosen by the physician, after 7 or 14 days.	No
Secondary	Patient rating of tolerability and treatment results		Depending on treatment time chosen by the physician, after 7 or 14 days.	No
Secondary	Physician's rating of tolerability and treatment results		Depending on treatment time chosen by the physician, after 7 or 14 days.	No

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