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Observational Program Neo-Penotran® Forte

Observational Program Neo-Penotran® Forte

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01335373
Enrollment
13024
Registered
2011-04-14
Start date
2010-10-31
Completion date
2015-04-30
Last updated
2016-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginosis, Trichomonal Vaginitis, Vaginal Candidiasis

Keywords

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

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.

Interventions

DRUGMetronidazole/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.

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Percent rate of different vaginal infectionsApproximately within 6 months after the last patient last visit.

Secondary

MeasureTime frame
Clinical characteristics of vaginitis after treatment.Depending on treatment time chosen by the physician, after 7 or 14 days.
Change of microbiological characteristics after treatmentDepending on treatment time chosen by the physician, after 7 or 14 days.
Patient rating of tolerability and treatment resultsDepending on treatment time chosen by the physician, after 7 or 14 days.
Physician's rating of tolerability and treatment resultsDepending on treatment time chosen by the physician, after 7 or 14 days.

Countries

Kazakhstan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026