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Trial record 3 of 5 for:    Open Studies | "Candidiasis, Vulvovaginal"
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Observational Program Neo-Penotran® Forte

This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01335373
First received: January 21, 2011
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Vaginal Candidiasis
Bacterial Vaginosis
Trichomonal Vaginitis
 Drug: Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Program Neo-Penotran® Forte

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Percent rate of different vaginal infections [ Time Frame: Approximately within 6 months after the last patient last visit. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical characteristics of vaginitis after treatment. [ Time Frame: Depending on treatment time chosen by the physician, after 7 or 14 days. ] [ Designated as safety issue: No ]
  • Change of microbiological characteristics after treatment [ Time Frame: Depending on treatment time chosen by the physician, after 7 or 14 days. ] [ Designated as safety issue: No ]
  • Patient rating of tolerability and treatment results [ Time Frame: Depending on treatment time chosen by the physician, after 7 or 14 days. ] [ Designated as safety issue: No ]
  • Physician's rating of tolerability and treatment results [ Time Frame: Depending on treatment time chosen by the physician, after 7 or 14 days. ] [ Designated as safety issue: No ]

Estimated Enrollment: 20000
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients in primary care setting.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335373

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Kazakhstan
Recruiting
Many Locations, Kazakhstan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, "Bayer KAZ" Limited Liability Partnership
ClinicalTrials.gov Identifier: NCT01335373     History of Changes
Other Study ID Numbers: 15511, NP1010KZ
Study First Received: January 21, 2011
Last Updated: May 10, 2013
Health Authority: Kazakhstan: National Center for Expertise of Drugs, Medical Products and Equipment

Keywords provided by Bayer:
Vaginal candidiasis
Bacterial vaginosis (also known as non-specific, or Gardnerellosis, or anaerobic vaginosis)
Trichomonal vaginitis
Vaginitis due to mixed infection

Additional relevant MeSH terms:
Candidiasis, Vulvovaginal
Candidiasis
Trichomonas Vaginitis
Vaginitis
Vaginosis, Bacterial
Mycoses
Vulvovaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases
Trichomonas Infections
Protozoan Infections
Parasitic Diseases
 Bacterial Infections
Miconazole
Metronidazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 21, 2013