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Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment

NCT ID: NCT01144286

Last Updated: 2013-10-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-03-31

Brief Summary

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In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic efficacy, safety and tolerability of three different doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).

Detailed Description

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Conditions

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Vulvovaginal Candidiasis

Keywords

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VVC candidiasis vaginal candidiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

placebo pessary, single dose

Group Type PLACEBO_COMPARATOR

arasertaconazole nitrate

Intervention Type DRUG

Arasertaconazole nitrate pessary, placebo pessary

Arasertaconazole nitrate 150 mg

Arasertaconazole nitrate 150 mg pessary, single dose

Group Type EXPERIMENTAL

arasertaconazole nitrate

Intervention Type DRUG

Arasertaconazole nitrate pessary, placebo pessary

placebo

Intervention Type DRUG

placebo, single dose

arasertaconazole nitrate 300 mg

Arasertaconazole nitrate 300 mg pessary, single dose

Group Type EXPERIMENTAL

arasertaconazole nitrate

Intervention Type DRUG

Arasertaconazole nitrate pessary, placebo pessary

placebo

Intervention Type DRUG

placebo, single dose

arasertaconazole 600 mg

Arasertaconazole nitrate 600 mg pessary, single dose

Group Type EXPERIMENTAL

arasertaconazole nitrate

Intervention Type DRUG

Arasertaconazole nitrate pessary, placebo pessary

placebo

Intervention Type DRUG

placebo, single dose

Interventions

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arasertaconazole nitrate

Arasertaconazole nitrate pessary, placebo pessary

Intervention Type DRUG

placebo

placebo, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women aged between 18 to 65 years of age who have signed the informed consent.
* Not pregnant, not nursing.
* No indication of other vulvovaginitis or genital infections
* Positive 10% potassium hydroxide (KOH) preparation for budding yeast and/or pseudohyphae.
* Negative wet mount results for T. vaginalis and clue cells.

Exclusion Criteria

* Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response.
* Hypersensitivity to imidazole products administered topically.
* Any other medical condition which in the opinion of the investigator could interfere with study conduct.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ferrer Internacional S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ferrer Internacional S.A.

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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2009-016655-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P-090756-01

Identifier Type: -

Identifier Source: org_study_id