ClotrimazolePhase 3NCT00755053
Comparative Efficacy of Ovule vs Tablet
A Phase 3 study testing Clotrimazole, vaginal ovule and Clotrimazole, vaginal tablet in people with Clotrimazole and Ovulen, run by Bayer at 17 sites in 2 countries.
Trial summary
The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet) Read more about this study
- Who is it for?
- Ages 14 to 50 years, women only
- Conditions the study is for
- Clotrimazole, Ovulen, Vulvovaginal Candidiasis
- What is being tested?
- Clotrimazole, vaginal ovule and Clotrimazole, vaginal tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Sep 2008to May 2009
- Phase
- Phase 3
- 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 14 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Non-pregnant females aged at least 14 years in Germany or at least 16 years in Russia and not older than 50 years.
- Subjects presenting a symptomatic vulvovaginal yeast infection confirmed by microscopic evaluation (wet mount preparation).
- Subjects must be cooperative, able to understand the requirements of the trial participation, and willing to participate in the trial. For adolescents the informed consent has to be provided to a legal representative in addition.
- Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.
- Negative saline smear for Trichomonas vaginalis
Who cannot join
- Subjects with known hypersensitivity to imidazoles or triazoles and their analogues.
- Subjects presenting a protozoan infection as confirmed by microscopic investigation.
- Pregnant, breast feeding or lactating subjects.
- Subjects with suspected bacterial vaginal infection.
- Subjects with abdominal pain, fever, or foul smelling vaginal discharge.
- Subjects who had a vaginal infection, or who had used an intravaginal or systemic antimycotic treatment within 60 days prior to visit 1.
Show all 15Show fewer
- Subjects using or wishing to use intra-vaginal or systemic anti-infectives or systemic antifungal therapy during the trial.
- Subjects wishing to use contraceptive foams, creams, jellies, sponges, therapeutic ointments, condoms, diaphragms, and OTC vaginal products during treatment and 3 days thereafter (i.e. until day 4).
- Subjects unable to refrain from the use of vaginal tampons during treatment and for 3 days thereafter (i.e. until day 4).
- Subjects unable to refrain from the use of feminine hygiene products (e.g. douches, feminine deodorant products) for 2 weeks (i.e. from visit 1 until visit 2).
- Subjects suffering from chronic/recurrent vulvovaginal mycosis, defined as 4 or more mycologically proven symptomatic episodes during the last 12 months.
- Subjects suffering from diseases (e.g. diabetes, decreased cellular immunity) or being treated with drugs (e.g. immunosuppressants, corticosteroids, anti-infectives) which may predispose them to mycological infections.
- Subjects who received another investigational drug within 30 days before visit 1.
- Unwillingness to refrain from sexual activity during 3 days thereafter.
- Actual menstruation at visit 1 or expected menstruation within 4 days after visit 1.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Germany12 sites
Study site
Dortmund, North Rhine-Westphalia, 44319
Study site
Frankfurt am Main, Hesse, 65929
Study site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Study site
Fulda, Hesse, 36037
Study site
Hamburg, Free and Hanseatic City of Hamburg, 22159
Study site
Hamburg, Free and Hanseatic City of Hamburg, 22359
Study site
Hanover, Lower Saxony, 30459
Study site
Krefeld, North Rhine-Westphalia, 47799
Study site
München, Bavaria, 80333
Study site
München, Bavaria, 85356
Study site
Osnabrück, Lower Saxony, 49074
Study site
Wiesbaden, Hesse, 65197
Russia5 sites
Study site
Moscow, 117198
Study site
Moscow, 119002
Study site
Moscow, 119049
Study site
Moscow, 127473
Study site
Moscow, 129090
About this study
Official title: An Investigator-blinded, Active-controlled Phase 3 Study to Prove the Non-inferior Efficacy of a Clotrimazole Ovule (500 mg) Versus a Clotrimazole Vaginal Tablet (500 mg) in Vaginal Candidiasis
The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet)
- Conditions
- Clotrimazole, Ovulen, Vulvovaginal Candidiasis
- Being tested
- Clotrimazole, vaginal ovule, Clotrimazole, vaginal tablet
- Keywords
- Clotrimazole, Ovule, Tablet, Vulvovaginal candidiasis, Non-inferiority
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clotrimazole, vaginal ovuleDrug
Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).
Clotrimazole, vaginal tabletDrug
Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
| Study group | Role | What they receive |
|---|---|---|
| Clotrimazole tablet (Canesten, BAY-B5097) | Active comparator | Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0). Receives: Drug: Clotrimazole, vaginal tablet |
| Clotrimazole ovule (Canesten, BAY-B5097) | Experimental | Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0). Receives: Drug: Clotrimazole, vaginal ovule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)
Measured: 10-14 days after treatment (=visit 2)
Secondary outcomes (5)
Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8)
Measured: 6-8 weeks after treatment (=visit 3)
Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14)
Measured: 10-14 days after treatment (=visit 2)
Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8)
Measured: 6-8 weeks after treatment (=visit 3)
Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14)
Measured: 10-14 days after treatment (=visit 2)
Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8)
Measured: 6-8 weeks after treatment (=visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClotrimazoleStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755053
- Sponsor's protocol ID
- 13071
- Other IDs
- 2008-000718-63, 2008
- Status last verified
- Jul 2015
- First submitted
- 17 Sep 2008
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-blinded, Active-controlled Phase 3 Study to Prove the Non-inferior Efficacy of a Clotrimazole Ovule (500 mg) Versus a Clotrimazole Vaginal Tablet (500 mg) in Vaginal Candidiasis
- ClinicalTrials.gov ID
- NCT00755053
- Acronym / sponsor ID
- 13071
- Conditions
- Clotrimazole, Ovulen, Vulvovaginal Candidiasis
- Keywords
- Clotrimazole, Ovule, Tablet, Vulvovaginal candidiasis, Non-inferiority
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 18 Sep 2008 (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.
The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clotrimazole tablet (Canesten, BAY-B5097) | Active comparator | Drug: Clotrimazole, vaginal tabletSingle intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0). |
| Clotrimazole ovule (Canesten, BAY-B5097) | Experimental | Drug: Clotrimazole, vaginal ovuleSingle intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0). |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Non-pregnant females aged at least 14 years in Germany or at least 16 years in Russia and not older than 50 years.
- Subjects presenting a symptomatic vulvovaginal yeast infection confirmed by microscopic evaluation (wet mount preparation).
- Subjects must be cooperative, able to understand the requirements of the trial participation, and willing to participate in the trial. For adolescents the informed consent has to be provided to a legal representative in addition.
- Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.
- Negative saline smear for Trichomonas vaginalis
Key exclusion criteria (15 listed)
- Subjects with known hypersensitivity to imidazoles or triazoles and their analogues.
- Subjects presenting a protozoan infection as confirmed by microscopic investigation.
- Pregnant, breast feeding or lactating subjects.
- Subjects with suspected bacterial vaginal infection.
- Subjects with abdominal pain, fever, or foul smelling vaginal discharge.
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 |
|---|---|---|
| Clotrimazole, vaginal ovuleSingle intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0). | Drug | Clotrimazole ovule (Canesten, BAY-B5097) |
| Clotrimazole, vaginal tabletSingle intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0). | Drug | Clotrimazole tablet (Canesten, BAY-B5097) |
Primary outcome
Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)
Time frame: 10-14 days after treatment (=visit 2)
5 secondary outcomes
Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8)
Time frame: 6-8 weeks after treatment (=visit 3)
Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14)
Time frame: 10-14 days after treatment (=visit 2)
Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8)
Time frame: 6-8 weeks after treatment (=visit 3)
Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14)
Time frame: 10-14 days after treatment (=visit 2)
Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8)
Time frame: 6-8 weeks after treatment (=visit 3)
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 6 Aug 2015.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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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
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clotrimazole, vaginal ovule and Clotrimazole, vaginal tablet in people with Clotrimazole and Ovulen, run by Bayer at 17 sites in 2 countries.
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 5 inclusion and 15 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 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Russia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14) (time frame: 10-14 days after treatment (=visit 2)). 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 6 Aug 2015.