check_circleStudy Completed

Vaginal candidiasis, Bacterial vaginosis, Trichomonal vaginitis

Bayer Identifier:

15511

ClinicalTrials.gov Identifier:

NCT01335373

EudraCT Number:

Not Available

EU CT Number:

Not Available
Observational program Neo-Penotran® Forte

Trial 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.

Key Participants Requirements

Sex

Female

Age

18 - 90 Years
  • - 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.
  • - Presence of contraindications according to package insert.

Trial summary

Enrollment Goal
13024
Trial Dates
October 2010 - April 2015
Phase
N/A
Could I Receive a placebo
No
Products
Neo-Penotran Forte(Metronidazole/Miconazole, BAY86-5276)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Kazakhstan

Primary Outcome

  • Percent rate of different vaginal infections
    date_rangeTime Frame:
    Approximately within 6 months after the last patient last visit.
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    Safety Issue:
    No

Secondary Outcome

  • Clinical characteristics of vaginitis after treatment.
    date_rangeTime Frame:
    Depending on treatment time chosen by the physician, after 7 or 14 days.
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    Safety Issue:
    No
  • Change of microbiological characteristics after treatment
    date_rangeTime Frame:
    Depending on treatment time chosen by the physician, after 7 or 14 days.
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    Safety Issue:
    No
  • Patient rating of tolerability and treatment results
    date_rangeTime Frame:
    Depending on treatment time chosen by the physician, after 7 or 14 days.
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    Safety Issue:
    No
  • Physician's rating of tolerability and treatment results
    date_rangeTime Frame:
    Depending on treatment time chosen by the physician, after 7 or 14 days.
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    Safety Issue:
    No

Trial design

Observational program Neo-Penotran® Forte
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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