Observational Program Neo-Penotran® Forte

July 22, 2016 updated by: Bayer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

13024

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients in primary care setting.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent rate of different vaginal infections
Time Frame: Approximately within 6 months after the last patient last visit.
Approximately within 6 months after the last patient last visit.

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical characteristics of vaginitis after treatment.
Time Frame: Depending on treatment time chosen by the physician, after 7 or 14 days.
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.
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.
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.
Depending on treatment time chosen by the physician, after 7 or 14 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 21, 2011

First Submitted That Met QC Criteria

April 13, 2011

First Posted (Estimate)

April 14, 2011

Study Record Updates

Last Update Posted (Estimate)

July 25, 2016

Last Update Submitted That Met QC Criteria

July 22, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15511
  • NP1010KZ (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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