Comparative Efficacy of Ovule vs Tablet

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00755053

Collaborator

(none)

466

Enrollment

Locations

Arms

Duration (Months)

27.4

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Clotrimazole Ovulen Vulvovaginal Candidiasis	Drug: Clotrimazole, vaginal ovule Drug: Clotrimazole, vaginal tablet	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

466 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2008

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Clotrimazole tablet (Canesten, BAY-B5097) Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).	Drug: Clotrimazole, vaginal tablet Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
Experimental: Clotrimazole ovule (Canesten, BAY-B5097) Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).	Drug: Clotrimazole, vaginal ovule Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).

Arm

Intervention/Treatment

Active Comparator: Clotrimazole tablet (Canesten, BAY-B5097)

Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).

Drug: Clotrimazole, vaginal tablet

Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).

Experimental: Clotrimazole ovule (Canesten, BAY-B5097)

Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).

Drug: Clotrimazole, vaginal ovule

Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).

Outcome Measures

Primary Outcome Measures

Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14) [10-14 days after treatment (=visit 2)]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Freiburg	Baden-Württemberg	Germany	79106
2	München	Bayern	Germany	80333
3	München	Bayern	Germany	85356
4	Frankfurt	Hessen	Germany	65929
5	Fulda	Hessen	Germany	36037
6	Wiesbaden	Hessen	Germany	65197
7	Hannover	Niedersachsen	Germany	30459
8	Osnabrück	Niedersachsen	Germany	49074
9	Dortmund	Nordrhein-Westfalen	Germany	44319
10	Krefeld	Nordrhein-Westfalen	Germany	47799
11	Hamburg		Germany	22159
12	Hamburg		Germany	22359
13	Moscow		Russian Federation	117198
14	Moscow		Russian Federation	119002
15	Moscow		Russian Federation	119049
16	Moscow		Russian Federation	127473
17	Moscow		Russian Federation	129090