Who is sponsoring NCT01144286?

NCT01144286 is sponsored by Ferrer Internacional S.A..

What drugs are being tested in NCT01144286?

Interventions in NCT01144286: arasertaconazole nitrate, placebo.

What condition does NCT01144286 study?

NCT01144286 studies Vulvovaginal Candidiasis.

Is NCT01144286 still recruiting?

NCT01144286 is currently completed. Last updated 28 August 2013.

Are results published for NCT01144286?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2013-08-28 · How we verify

NCT01144286

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 28 August 2013

What this trial tests

Phase 2 trial testing arasertaconazole nitrate in Vulvovaginal Candidiasis in 229 participants. Completed in 1 March 2011.

Timeline

1 June 2010

Primary endpoint
1 March 2011

1 March 2011

Quick facts

Lead sponsor	Ferrer Internacional S.A.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	229
Start date	1 June 2010
Primary completion	1 March 2011
Estimated completion	1 March 2011
Sites	1 location across Spain

Drugs / interventions tested

arasertaconazole nitrate — full drug profile →
placebo

Conditions studied

Vulvovaginal Candidiasis — all drugs for Vulvovaginal Candidiasis →

Sponsor

Ferrer Internacional S.A. — full company profile →

Who can join

Adults 18 to 65, female only, with Vulvovaginal Candidiasis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Dose-response of Clinical and Mycological (Global) Therapeutic Response
Time frame: day 26 ± 4 days
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".

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Vulvovaginal Candidiasis

Currently open trials in the same condition.

NCT05753813 — Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome · EARLY_PHASE1 · recruiting
NCT05908682 — Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes · recruiting
NCT05079711 — Comparative Performance of a Vaginal Yeast Test · recruiting

Other Ferrer Internacional S.A. trials

Trials by the same sponsor.

NCT06499363 — Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Sa · recruiting
NCT05866926 — Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis · Phase 3 · terminated
NCT05178810 — Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral Scler · Phase 3 · completed
NCT04065529 — Clinical Trial in Children Between 3 Months and 14 Years Old to Evaluate the Efficacy and Safety of Gelatin Tannate in t · Phase 3 · completed
NCT02525991 — Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01144286 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ferrer Internacional S.A.
Last refreshed: 28 August 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01144286.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing