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OpenTrials
Completed

NCT Number: NCT01335373

Observational Program Neo-Penotran® Forte

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.

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Key information

Conditions

Vaginal Candidiasis Bacterial Infections Bacterial Infections and Mycoses Bacterial Vaginosis Candidiasis Candidiasis, Vulvovaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Parasitic Diseases Protozoan Infections Trichomonal Vaginitis Trichomonas Infections Trichomonas Vaginitis Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Kazakhstan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276)

Drug

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.

Primary outcomes

  1. Percent rate of different vaginal infections

    Time frame: Approximately within 6 months after the last patient last visit.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2015
First posted
Apr 14, 2011
Registry last updated
Jul 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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