Vulvovaginal CandidiasisNCT01039584
A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations
A study testing Butoconazole Nitrate Vaginal Cream and Gynazole 1 vaginal cream in people with Vulvovaginal Candidiasis, run by Padagis LLC at 1 site in United States.
Trial summary
This was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of vulvovaginal candidiasis caused by Candida species. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvovaginal Candidiasis
- What is being tested?
- Butoconazole Nitrate Vaginal Cream and Gynazole 1 vaginal cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 611 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Dec 2009
- Phase
- Interventional
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female subjects, at least 18 years of age
- Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
- Signed and dated informed consent
Who cannot join
- Were pregnant, nursing, or planning a pregnancy within the study participation period
- Had evidence of any bacterial, viral, or protozoal infection
- Had hypersensitivity or allergy to the imidazoles, their analogues, and/or any of the Test Product ingredients
- Had any medical condition, or used any medication which, in the opinion of the investigator, could have interfered with the conduct of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
PharmaNet, Inc. (PharmaNet)
Charlotte, North Carolina, 28262
About this study
Official title: A Randomized Study Evaluating the Therapeutic Equivalence and Safety of Butoconazole Nitrate Vaginal Cream, 2% and Gynazole 1 (Butoconazole Nitrate) Vaginal Cream, 2%, Against a Vehicle Control in the Treatment of Vulvovaginal Candidiasis
This was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of vulvovaginal candidiasis caused by Candida species.
- Conditions
- Vulvovaginal Candidiasis
- Being tested
- Butoconazole Nitrate Vaginal Cream, Placebo, Gynazole 1 vaginal cream
- Keywords
- bioequivalence, butoconazole, vulvovaginal, 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.
Butoconazole Nitrate Vaginal CreamDrug
vaginal cream
PlaceboDrug
Also called vehicle of the test product
vaginal cream
Gynazole 1 vaginal creamDrug
Also called Gynazole 1
vaginal cream
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | vehicle of the test product; applied intravaginally once within 48 hours of randomization Receives: Drug: Placebo |
| Test Product | Experimental | Butoconazole Nitrate Vaginal Cream; applied intravaginally once within 48 hours of randomization Receives: Drug: Butoconazole Nitrate Vaginal Cream |
| Reference Product | Active comparator | Gynazole 1 Vaginal Cream; applied intravaginally once within 48 hours of randomization Receives: Drug: Gynazole 1 vaginal cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure.
Therapeutic cure is defined as both the mycologically-proven eradication of infection caused by Candida species (mycological cure) and evidence of clinical success (clinical cure)
Measured: Visit 3: Day 22-31
Secondary outcomes (2)
Clinical Cure
Clinical cure (clinical success) was defined as follows:
- All signs or symptoms with a score of 1 (mild) or 2 (moderate) at Visit 1/Baseline had a score of 0 (absent) at Visit 3/Test-of-Cure, or all signs or symptoms with a score of 3 (severe) at Visit 1/Baseline had a score of 0 (absent) or 1 (mild) at Visit 3/Test-of-Cure
- A new sign or symptoms was observed at Visit 3/Test-of-Cure that was not present at entry and was determined by the investigator to not be related to VVC (if related, the subject was considered a failure; if not related, the subject could have been considered a cure)
- The subject did not require additional vulvovaginal or systemic antifungal therapy
- The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus, such as topical analgesics or corticosteroid products
Measured: Visit 3: Day 22-31
Mycological Cure
Mycological cure was defined as a negative mycological culture (no growth)
Measured: Visit 3: Day 22-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startFeb 2008
- Primary completionSep 2009
- Study completionDec 2009
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 611 participants (actual)
Sponsor and investigators
- Lead sponsor
- Padagis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039584
- Sponsor's protocol ID
- PRG-710
- Status last verified
- Jul 2023
- First submitted
- 23 Dec 2009
- Last updated
- 12 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Evaluating the Therapeutic Equivalence and Safety of Butoconazole Nitrate Vaginal Cream, 2% and Gynazole 1 (Butoconazole Nitrate) Vaginal Cream, 2%, Against a Vehicle Control in the Treatment of Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT01039584
- Acronym / sponsor ID
- PRG-710
- Conditions
- Vulvovaginal Candidiasis
- Keywords
- bioequivalence, butoconazole, vulvovaginal, candidiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Dec 2009 (estimated)
- Results
- Posted 21 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of vulvovaginal candidiasis caused by Candida species.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebovehicle of the test product; applied intravaginally once within 48 hours of randomization |
| Test Product | Experimental | Drug: Butoconazole Nitrate Vaginal CreamButoconazole Nitrate Vaginal Cream; applied intravaginally once within 48 hours of randomization |
| Reference Product | Active comparator | Drug: Gynazole 1 vaginal creamGynazole 1 Vaginal Cream; applied intravaginally once within 48 hours of randomization |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female subjects, at least 18 years of age
- Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
- Signed and dated informed consent
Key exclusion criteria (4 listed)
- Were pregnant, nursing, or planning a pregnancy within the study participation period
- Had evidence of any bacterial, viral, or protozoal infection
- Had hypersensitivity or allergy to the imidazoles, their analogues, and/or any of the Test Product ingredients
- Had any medical condition, or used any medication which, in the opinion of the investigator, could have interfered with the conduct of the study
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 |
|---|---|---|
| Butoconazole Nitrate Vaginal Creamvaginal cream | Drug | Test Product |
| PlaceboAlso: vehicle of the test productvaginal cream | Drug | Placebo |
| Gynazole 1 vaginal creamAlso: Gynazole 1vaginal cream | Drug | Reference Product |
Primary outcome
The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure.
Time frame: Visit 3: Day 22-31
Therapeutic cure is defined as both the mycologically-proven eradication of infection caused by Candida species (mycological cure) and evidence of clinical success (clinical cure)
2 secondary outcomes
Clinical Cure
Time frame: Visit 3: Day 22-31
Mycological Cure
Time frame: Visit 3: Day 22-31
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- 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 study testing Butoconazole Nitrate Vaginal Cream and Gynazole 1 vaginal cream in people with Vulvovaginal Candidiasis, run by Padagis LLC at 1 site in United States.
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 3 inclusion and 4 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 12 Jul 2023. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 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?
The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure. (time frame: Visit 3: Day 22-31). 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 12 Jul 2023.