Clotrimazole, Ovulen, Vulvovaginal Candidiasis
Conditions
Keywords
Clotrimazole, Ovule, Tablet, Vulvovaginal candidiasis, Non-inferiority
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)
Interventions
DRUGClotrimazole, vaginal ovule
Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).
DRUGClotrimazole, vaginal tablet
Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14) | 10-14 days after treatment (=visit 2) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8) | 6-8 weeks after treatment (=visit 3) |
| Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14) | 10-14 days after treatment (=visit 2) |
| Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8) | 6-8 weeks after treatment (=visit 3) |
| Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14) | 10-14 days after treatment (=visit 2) |
| Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8) | 6-8 weeks after treatment (=visit 3) |
Countries
Germany, Russia
Outcome results
None listed