Clinical trial NCT00755053: Comparative Efficacy of Ovule vs Tablet
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Clotrimazole
Ovulen
Vulvovaginal Candidiasis
Keywords: Clotrimazole
Ovule
Tablet
Vulvovaginal candidiasis
Non-inferiority
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-09-18
Enrollment: 466
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)
timeFrame: 10-14 days after treatment (=visit 2)
Secondary outcomes:
measure: Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8)
timeFrame: 6-8 weeks after treatment (=visit 3)
measure: Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14)
timeFrame: 10-14 days after treatment (=visit 2)
measure: Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8)
timeFrame: 6-8 weeks after treatment (=visit 3)
measure: Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14)
timeFrame: 10-14 days after treatment (=visit 2)
measure: Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8)
timeFrame: 6-8 weeks after treatment (=visit 3)
Other outcomes:
Locations:
city: Freiburg
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Frankfurt
country: Germany
state: Hessen
city: Fulda
country: Germany
state: Hessen
city: Wiesbaden
country: Germany
state: Hessen
city: Hannover
country: Germany
state: Niedersachsen
city: Osnabrück
country: Germany
state: Niedersachsen
city: Dortmund
country: Germany
state: Nordrhein-Westfalen
city: Krefeld
country: Germany
state: Nordrhein-Westfalen
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: