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

Primary Purpose

Vulvovaginal Candidiasis

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
arasertaconazole nitrate
placebo
Sponsored by
Ferrer Internacional S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvovaginal Candidiasis focused on measuring VVC, candidiasis, vaginal candidiasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ferrer Internacional S.A.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

placebo

Arasertaconazole nitrate 150 mg

arasertaconazole nitrate 300 mg

arasertaconazole 600 mg

Arm Description

placebo pessary, single dose

Arasertaconazole nitrate 150 mg pessary, single dose

Arasertaconazole nitrate 300 mg pessary, single dose

Arasertaconazole nitrate 600 mg pessary, single dose

Outcomes

Primary Outcome Measures

Dose-response of Clinical and Mycological (Global) Therapeutic Response
Global therapeutic response at day 26± 4 days ("TOC"- Test-of-Cure visit).Global therapeutic response is a composite endpoint using the clinical (signs and symptoms) and the mycological cures (microbiological culture), according to FDA guideline "Vulvovaginal Candidiasis -Developing Antimicrobial Drugs for Treatment".

Secondary Outcome Measures

Dose-response of Clinical and Mycological (Global)Therapeutic Response
Global therapeutic response at day 8± 2 days. Safety and tolerability.

Full Information

First Posted
June 9, 2010
Last Updated
August 28, 2013
Sponsor
Ferrer Internacional S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01144286
Brief Title
Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment
Official Title
Multi-center, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study to Compare the Therapeutic Efficacy, Safety, and Tolerability of 3 Single Vaginal Doses of Arasertaconazole Nitrate Pessaries in the Treatment of VVC
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferrer Internacional S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Candidiasis
Keywords
VVC, candidiasis, vaginal candidiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo pessary, single dose
Arm Title
Arasertaconazole nitrate 150 mg
Arm Type
Experimental
Arm Description
Arasertaconazole nitrate 150 mg pessary, single dose
Arm Title
arasertaconazole nitrate 300 mg
Arm Type
Experimental
Arm Description
Arasertaconazole nitrate 300 mg pessary, single dose
Arm Title
arasertaconazole 600 mg
Arm Type
Experimental
Arm Description
Arasertaconazole nitrate 600 mg pessary, single dose
Intervention Type
Drug
Intervention Name(s)
arasertaconazole nitrate
Intervention Description
Arasertaconazole nitrate pessary, placebo pessary
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo, single dose
Primary Outcome Measure Information:
Title
Dose-response of Clinical and Mycological (Global) Therapeutic Response
Description
Global therapeutic response at day 26± 4 days ("TOC"- Test-of-Cure visit).Global therapeutic response is a composite endpoint using the clinical (signs and symptoms) and the mycological cures (microbiological culture), according to FDA guideline "Vulvovaginal Candidiasis -Developing Antimicrobial Drugs for Treatment".
Time Frame
day 26 ± 4 days
Secondary Outcome Measure Information:
Title
Dose-response of Clinical and Mycological (Global)Therapeutic Response
Description
Global therapeutic response at day 8± 2 days. Safety and tolerability.
Time Frame
Day 8 ± 2 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ferrer Internacional S.A.
City
Barcelona
ZIP/Postal Code
08028
Country
Spain

12. IPD Sharing Statement

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

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