Observational Program Neo-Penotran® Forte

Bayer0 sites13,024 target enrollmentOctober 2010

ConditionsVaginal Candidiasis Bacterial Vaginosis Trichomonal Vaginitis

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

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

Overview

Phase: Not Applicable
Intervention: Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276)
Conditions: Vaginal Candidiasis
Sponsor: Bayer
Enrollment: 13024
Primary Endpoint: Percent rate of different vaginal infections
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

April 2015

Last Updated

9 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Group 1

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

Outcomes

Primary Outcomes

Percent rate of different vaginal infections

Time Frame: 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.)