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Comparative Efficacy of Ovule vs Tablet

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Clotrimazole; Ovulen; Vulvovaginal Candidiasis

Intervention: Clotrimazole, vaginal ovule (Drug); Clotrimazole, vaginal tablet (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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)

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)

Secondary outcome:

Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8)

Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14)

Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8)

Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14)

Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8)

Eligibility

Minimum age: 14 Years. Maximum age: 50 Years. Gender(s): Female.

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.

Locations and Contacts

Hamburg 22159, Germany

Hamburg 22359, Germany

Moscow 117198, Russian Federation

Moscow 119002, Russian Federation

Moscow 119049, Russian Federation

Moscow 127473, Russian Federation

Moscow 129090, Russian Federation

Freiburg, Baden-Württemberg 79106, Germany

München, Bayern 80333, Germany

München, Bayern 85356, Germany

Frankfurt, Hessen 65929, Germany

Fulda, Hessen 36037, Germany

Wiesbaden, Hessen 65197, Germany

Hannover, Niedersachsen 30459, Germany

Osnabrück, Niedersachsen 49074, Germany

Dortmund, Nordrhein-Westfalen 44319, Germany

Krefeld, Nordrhein-Westfalen 47799, Germany

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Starting date: September 2008
Last updated: August 4, 2015

Page last updated: August 23, 2015

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