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Observational Program Neo-Penotran® Forte

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01335373
First received: January 21, 2011
Last updated: July 22, 2016
Last verified: May 2016
  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:


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 ]

Enrollment: 13024
Study Start Date: October 2010
Study Completion Date: April 2015
Primary Completion Date: December 2011 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01335373     History of Changes
Other Study ID Numbers: 15511  NP1010KZ 
Study First Received: January 21, 2011
Last Updated: July 22, 2016
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
Vaginal Diseases
Vaginosis, Bacterial
Vaginitis
Candidiasis, Vulvovaginal
Trichomonas Vaginitis
Mycoses
Genital Diseases, Female
Bacterial Infections
Vulvovaginitis
Vulvitis
Vulvar Diseases
Trichomonas Infections
Protozoan Infections
Parasitic Diseases
Metronidazole
Miconazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Antifungal Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors

ClinicalTrials.gov processed this record on December 08, 2016