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Trial record 1 of 1 for:    NCT01335373
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Observational Program Neo-Penotran® Forte

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ClinicalTrials.gov Identifier: NCT01335373
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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.


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

Study Design
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Study Type : Observational
Actual Enrollment : 13024 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Program Neo-Penotran® Forte
Study Start Date : October 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Percent rate of different vaginal infections [ Time Frame: Approximately within 6 months after the last patient last visit. ]

Secondary Outcome Measures :
  1. Clinical characteristics of vaginitis after treatment. [ Time Frame: Depending on treatment time chosen by the physician, after 7 or 14 days. ]
  2. Change of microbiological characteristics after treatment [ Time Frame: Depending on treatment time chosen by the physician, after 7 or 14 days. ]
  3. Patient rating of tolerability and treatment results [ Time Frame: Depending on treatment time chosen by the physician, after 7 or 14 days. ]
  4. Physician's rating of tolerability and treatment results [ Time Frame: Depending on treatment time chosen by the physician, after 7 or 14 days. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335373


Locations
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Kazakhstan
Many Locations, Kazakhstan
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01335373    
Other Study ID Numbers: 15511
NP1010KZ ( Other Identifier: company internal )
First Posted: April 14, 2011    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: May 2016
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:
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Candidiasis
Vaginosis, Bacterial
Candidiasis, Vulvovaginal
Trichomonas Vaginitis
Vaginal Diseases
Vaginitis
Mycoses
Bacterial Infections and Mycoses
Infections
Bacterial Infections
Vulvovaginitis
Vulvitis
Vulvar Diseases
Trichomonas Infections
Protozoan Infections
 Parasitic Diseases
Metronidazole
Miconazole
Anti-Infective Agents
Anti-Bacterial 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