Trial Condition(s):
Vaginal candidiasis
Observational program Neo-Penotran® Forte
Bayer Identifier:
15511
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Kazakhstan | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Percent rate of different vaginal infectionsTimeframe: Approximately within 6 months after the last patient last visit.
Secondary Outcome
- Clinical characteristics of vaginitis after treatment.Timeframe: Depending on treatment time chosen by the physician, after 7 or 14 days.
- Change of microbiological characteristics after treatmentTimeframe: Depending on treatment time chosen by the physician, after 7 or 14 days.
- Patient rating of tolerability and treatment resultsTimeframe: Depending on treatment time chosen by the physician, after 7 or 14 days.
- Physician's rating of tolerability and treatment resultsTimeframe: Depending on treatment time chosen by the physician, after 7 or 14 days.
Additional Information
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