Trial · NCT01144286
Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment
NCT01144286, Phase 2, Completed, Ferrer Internacional S.A.; results first posted 2013-10-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment. Trials, record NCT01144286. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01144286
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment
- NCT number
- NCT01144286
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 229 participants, actual
- Lead sponsor
- Ferrer Internacional S.A.
- Conditions
- Vulvovaginal Candidiasis
- Interventions
- arasertaconazole nitrate, placebo
- First posted
- 2010-06-15
- Last updated
- 2013-10-09
- Other registries' IDs
- eudract:2009-016655-21
- Results first posted
- 2013-10-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-response of Clinical and Mycological (Global) Therapeutic Response | 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". |
| Secondary | Dose-response of Clinical and Mycological (Global)Therapeutic Response | Day 8 ± 2 days | Global therapeutic response at day 8± 2 days. Safety and tolerability. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose-response of Clinical and Mycological (Global) Therapeutic Response | day 26 ± 4 days | The full analysis set (FAS) was the primary population for the analysis of all efficacy endpoints. The FAS was defined as all randomized subjects who received at least 1 dose of a study drug.Subjects in the FAS were analyzed according to randomized treatment group. | percentage of patients cured | NUMBER |
| SECONDARY | Dose-response of Clinical and Mycological (Global)Therapeutic Response | Day 8 ± 2 days | Dose response tested using logistic regression-linear coefficient for treatment effect.Assuming response rate 80% for 600 mg, 75% for 300 mg, 65% for 150 mg and 50% for the placebo group, sample size of 45 subjects in each group have 90% power to detect linear dose response with 0.05 two-sided test of trend based on the logistic model. | percentage of cured participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose-response of Clinical and Mycological (Global) Therapeutic Response | Placebo | 31.7 | 95% Confidence Interval 18.08 to 48.09 | percentage of patients cured | |
| Dose-response of Clinical and Mycological (Global) Therapeutic Response | Arasertaconazole Nitrate 150 mg | 48.7 | 95% Confidence Interval 32.42 to 65.22 | percentage of patients cured | |
| Dose-response of Clinical and Mycological (Global) Therapeutic Response | Arasertaconazole Nitrate 300 mg | 47.6 | 95% Confidence Interval 32.00 to 63.58 | percentage of patients cured | |
| Dose-response of Clinical and Mycological (Global) Therapeutic Response | Arasertaconazole 600 mg | 53.8 | 95% Confidence Interval 37.18 to 69.91 | percentage of patients cured | |
| Dose-response of Clinical and Mycological (Global)Therapeutic Response | Placebo | 15.6 | 95% Confidence Interval 6.49 to 29.46 | percentage of cured participants | |
| Dose-response of Clinical and Mycological (Global)Therapeutic Response | Arasertaconazole Nitrate 150 mg | 34.2 | 95% Confidence Interval 19.63 to 51.35 | percentage of cured participants | |
| Dose-response of Clinical and Mycological (Global)Therapeutic Response | Arasertaconazole Nitrate 300 mg | 46.3 | 95% Confidence Interval 30.66 to 62.58 | percentage of cured participants | |
| Dose-response of Clinical and Mycological (Global)Therapeutic Response | Arasertaconazole 600 mg | 61.0 | 95% Confidence Interval 44.50 to 75.80 | percentage of cured participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 57 | |
| Overall Study | STARTED | Arasertaconazole Nitrate 150 mg | 58 | |
| Overall Study | STARTED | Arasertaconazole Nitrate 300 mg | 58 | |
| Overall Study | STARTED | Arasertaconazole 600 mg | 56 | |
| Overall Study | COMPLETED | Placebo | 57 | |
| Overall Study | COMPLETED | Arasertaconazole Nitrate 150 mg | 58 | |
| Overall Study | COMPLETED | Arasertaconazole Nitrate 300 mg | 58 | |
| Overall Study | COMPLETED | Arasertaconazole 600 mg | 56 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Arasertaconazole Nitrate 150 mg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events116
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | tonsilitis | Infections and infestations | Placebo | 1 | 57 | 1 |
| other | tonsilitis | Infections and infestations | Arasertaconazole Nitrate 150 mg | 0 | 58 | 0 |
| other | tonsilitis | Infections and infestations | Arasertaconazole Nitrate 300 mg | 0 | 58 | 0 |
| other | tonsilitis | Infections and infestations | Arasertaconazole 600 mg | 0 | 56 | 0 |
| other | Chamydial infection | Infections and infestations | Placebo | 1 | 57 | 1 |
| other | Chamydial infection | Infections and infestations | Arasertaconazole Nitrate 150 mg | 0 | 58 | 0 |
| other | Chamydial infection | Infections and infestations | Arasertaconazole Nitrate 300 mg | 0 | 58 | 0 |
| other | Chamydial infection | Infections and infestations | Arasertaconazole 600 mg | 0 | 56 | 0 |
| other | heat stroke | Injury, poisoning and procedural complications | Placebo | 1 | 57 | 1 |
| other | heat stroke | Injury, poisoning and procedural complications | Arasertaconazole Nitrate 150 mg | 0 | 58 | 0 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Arasertaconazole Nitrate 150 mg | ||
| Total, all-cause mortality | Arasertaconazole Nitrate 300 mg | ||
| Total, all-cause mortality | Arasertaconazole 600 mg | ||
| Total, other adverse events | Placebo | 6 | 57 |
| Total, other adverse events | Arasertaconazole Nitrate 150 mg | 9 | 58 |
| Total, other adverse events | Arasertaconazole Nitrate 300 mg | 13 | 58 |
| Total, other adverse events | Arasertaconazole 600 mg | 13 | 56 |
| Total, serious adverse events | Placebo | 0 | 57 |
| Total, serious adverse events | Arasertaconazole Nitrate 150 mg | 0 | 58 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01144286
GET https://conductscience.org/api/trials/v1/NCT01144286/events?page=2