Observational Program Neo-Penotran® Forte

NCT01335373 | Completed

• 2 other identifiers: 15511NP1010KZ
• Study Type: observational
• Target: 13,024
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Candidiasis; Bacterial Vaginosis; Trichomonal Vaginitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent rate of different vaginal infections

  Approximately within 6 months after the last patient last visit.

Secondary Outcomes (4)

• Clinical characteristics of vaginitis after treatment.

  Depending on treatment time chosen by the physician, after 7 or 14 days.

• Change of microbiological characteristics after treatment

  Depending on treatment time chosen by the physician, after 7 or 14 days.

• Patient rating of tolerability and treatment results

  Depending on treatment time chosen by the physician, after 7 or 14 days.

• Physician's rating of tolerability and treatment results

  Depending on treatment time chosen by the physician, after 7 or 14 days.

Study Arms (1)

Group 1

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

Interventions

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.

Group 1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in primary care setting.

You may qualify if:

• 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.

You may not qualify if:

• Presence of contraindications according to package insert.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Kazakhstan

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal; Vaginosis, Bacterial; Trichomonas Vaginitis

Interventions

Metronidazole; Miconazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: April 14, 2011
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2015
• Last Updated: July 25, 2016

Record last verified: 2016-05

Locations

KA (1)