Comparative Efficacy of Ovule vs Tablet

Bayer

Status and phase

Completed

Phase 3

Conditions

Vulvovaginal Candidiasis

Ovulen

Clotrimazole

Treatments

Drug: Clotrimazole, vaginal ovule

Drug: Clotrimazole, vaginal tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT00755053

2008-000718-63 (EudraCT Number)

13071

Details and patient eligibility

About

The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet)

Enrollment

466 patients

Sex

Female

Ages

14 to 50 years old

Volunteers

No Healthy Volunteers

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.