Vulvovaginal CandidiasisPhase 2NCT01144286
Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment
A Phase 2 study testing arasertaconazole nitrate in people with Vulvovaginal Candidiasis, run by Ferrer Internacional S.A. at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Vulvovaginal Candidiasis
- What is being tested?
- arasertaconazole nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 229 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2010to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Vulvovaginal Candidiasis
- Being tested
- arasertaconazole nitrate, placebo
- Keywords
- VVC, candidiasis, vaginal candidiasis
- Medical subject headings
- Candidiasis, Vulvovaginal, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arasertaconazole nitrateDrug
Arasertaconazole nitrate pessary, placebo pessary
placeboDrug
placebo, single dose
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo pessary, single dose Receives: Drug: arasertaconazole nitrate |
| Arasertaconazole nitrate 150 mg | Experimental | Arasertaconazole nitrate 150 mg pessary, single dose Receives: Drug: arasertaconazole nitrate; Drug: placebo |
| arasertaconazole nitrate 300 mg | Experimental | Arasertaconazole nitrate 300 mg pessary, single dose Receives: Drug: arasertaconazole nitrate; Drug: placebo |
| arasertaconazole 600 mg | Experimental | Arasertaconazole nitrate 600 mg pessary, single dose Receives: Drug: arasertaconazole nitrate; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: day 26 ± 4 days
Secondary outcomes (1)
Dose-response of Clinical and Mycological (Global)Therapeutic Response
Global therapeutic response at day 8± 2 days. Safety and tolerability.
Measured: Day 8 ± 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferrer Internacional S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144286
- Sponsor's protocol ID
- P-090756-01
- Other IDs
- 2009-016655-21, 2009
- Status last verified
- Aug 2013
- First submitted
- 9 Jun 2010
- Last updated
- 9 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01144286
- Acronym / sponsor ID
- P-090756-01
- Conditions
- Vulvovaginal Candidiasis
- Keywords
- VVC, candidiasis, vaginal candidiasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Ferrer Internacional S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Jun 2010 (estimated)
- Results
- Posted 9 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: arasertaconazole nitrateplacebo pessary, single dose |
| Arasertaconazole nitrate 150 mg | Experimental | Drug: arasertaconazole nitrate, Drug: placeboArasertaconazole nitrate 150 mg pessary, single dose |
| arasertaconazole nitrate 300 mg | Experimental | Drug: arasertaconazole nitrate, Drug: placeboArasertaconazole nitrate 300 mg pessary, single dose |
| arasertaconazole 600 mg | Experimental | Drug: arasertaconazole nitrate, Drug: placeboArasertaconazole nitrate 600 mg pessary, single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arasertaconazole nitrateArasertaconazole nitrate pessary, placebo pessary | Drug | Arasertaconazole nitrate 150 mg, arasertaconazole 600 mg, arasertaconazole nitrate 300 mg, placebo |
| placeboplacebo, single dose | Drug | Arasertaconazole nitrate 150 mg, arasertaconazole 600 mg, arasertaconazole nitrate 300 mg |
Primary outcome
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".
1 secondary outcome
Dose-response of Clinical and Mycological (Global)Therapeutic Response
Time frame: Day 8 ± 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing arasertaconazole nitrate in people with Vulvovaginal Candidiasis, run by Ferrer Internacional S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-response of Clinical and Mycological (Global) Therapeutic Response (time frame: day 26 ± 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2013.