Vaginal CandidiasisNCT01335373
Observational Program Neo-Penotran® Forte
An observational study of Vaginal Candidiasis and Bacterial Vaginosis, run by Bayer at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Vaginal Candidiasis, Bacterial Vaginosis, Trichomonal Vaginitis
- What is being tested?
- Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276)
- How many people
- 13,024 participants
- Where
- 1 siteKazakhstan
- Study dates
- Oct 2010to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients in primary care setting.
Who may be able to join
- 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.
Who cannot join
- Presence of contraindications according to package insert.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276)
- Keywords
- Vaginal candidiasis, Bacterial vaginosis (also known as non-specific, or Gardnerellosis, or anaerobic vaginosis), Trichomonal vaginitis, Vaginitis due to mixed infection
- Medical subject headings
- Candidiasis, Vulvovaginal, Vaginosis, Bacterial, Trichomonas Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent rate of different vaginal infections
Measured: Approximately within 6 months after the last patient last visit.
Secondary outcomes (4)
Clinical characteristics of vaginitis after treatment.
Measured: Depending on treatment time chosen by the physician, after 7 or 14 days.
Change of microbiological characteristics after treatment
Measured: Depending on treatment time chosen by the physician, after 7 or 14 days.
Patient rating of tolerability and treatment results
Measured: Depending on treatment time chosen by the physician, after 7 or 14 days.
Physician's rating of tolerability and treatment results
Measured: Depending on treatment time chosen by the physician, after 7 or 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal CandidiasisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13,024 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335373
- Sponsor's protocol ID
- 15511
- Other IDs
- NP1010KZ
- Status last verified
- May 2016
- First submitted
- 21 Jan 2011
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Program Neo-Penotran® Forte
- ClinicalTrials.gov ID
- NCT01335373
- Acronym / sponsor ID
- 15511
- Keywords
- Vaginal candidiasis, Bacterial vaginosis (also known as non-specific, or Gardnerellosis, or anaerobic vaginosis), Trichomonal vaginitis, Vaginitis due to mixed infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,024 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in primary care setting.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Presence of contraindications according to package insert.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metronidazole/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. | Drug | Group 1 |
Primary outcome
Percent rate of different vaginal infections
Time frame: Approximately within 6 months after the last patient last visit.
4 secondary outcomes
Clinical characteristics of vaginitis after treatment.
Time frame: Depending on treatment time chosen by the physician, after 7 or 14 days.
Change of microbiological characteristics after treatment
Time frame: Depending on treatment time chosen by the physician, after 7 or 14 days.
Patient rating of tolerability and treatment results
Time frame: Depending on treatment time chosen by the physician, after 7 or 14 days.
Physician's rating of tolerability and treatment results
Time frame: Depending on treatment time chosen by the physician, after 7 or 14 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Candidiasis and Bacterial Vaginosis, run by Bayer at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent rate of different vaginal infections (time frame: Approximately within 6 months after the last patient last visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2016.