NCT01144286

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

October 9, 2013

Completed
Last Updated

October 9, 2013

Status Verified

August 1, 2013

Enrollment Period

9 months

First QC Date

June 9, 2010

Results QC Date

May 8, 2013

Last Update Submit

August 28, 2013

Conditions

Vulvovaginal Candidiasis

Keywords

VVCcandidiasisvaginal candidiasis

Outcome Measures

Primary Outcomes (1)

  • 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".

    day 26 ± 4 days

Secondary Outcomes (1)

  • Dose-response of Clinical and Mycological (Global)Therapeutic Response

    Day 8 ± 2 days

Study Arms (4)

placebo

PLACEBO COMPARATOR

placebo pessary, single dose

Drug: arasertaconazole nitrate

Arasertaconazole nitrate 150 mg

EXPERIMENTAL

Arasertaconazole nitrate 150 mg pessary, single dose

Drug: arasertaconazole nitrateDrug: placebo

arasertaconazole nitrate 300 mg

EXPERIMENTAL

Arasertaconazole nitrate 300 mg pessary, single dose

Drug: arasertaconazole nitrateDrug: placebo

arasertaconazole 600 mg

EXPERIMENTAL

Arasertaconazole nitrate 600 mg pessary, single dose

Drug: arasertaconazole nitrateDrug: placebo

Interventions

arasertaconazole nitrateDRUG

Arasertaconazole nitrate pessary, placebo pessary

Arasertaconazole nitrate 150 mgarasertaconazole 600 mgarasertaconazole nitrate 300 mgplacebo
placeboDRUG

placebo, single dose

Arasertaconazole nitrate 150 mgarasertaconazole 600 mgarasertaconazole nitrate 300 mg

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ferrer Internacional S.A.

Barcelona, 08028, Spain

Location

MeSH Terms

Conditions

Candidiasis, VulvovaginalCandidiasis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsVulvovaginitisVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVulvitisVulvar DiseasesGenital Diseases

Results Point of Contact

Title
Vladimir Dvorak
Organization
Privatni gynekologicka ambulance
ssgcr@ti.cz
+420 542 221 661

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 15, 2010

Study Start

June 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

October 9, 2013

Results First Posted

October 9, 2013

Record last verified: 2013-08

Locations

ES(1)