Candidiasis, VulvovaginalPhase 4NCT02180828
Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
A Phase 4 study testing Clotrimazole vaginal tablet and Fluconazole in people with Candidiasis, Vulvovaginal, run by Peking University Shenzhen Hospital at 1 site in China.
Trial summary
The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs Fluconazole for the treatment of severe vulvovaginal candidiasis Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Candidiasis, Vulvovaginal
- What is being tested?
- Clotrimazole vaginal tablet and Fluconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Sep 2015
- Phase
- Phase 4
- 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 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7
- Subject completes the informed consent process
- Subject agrees to take study medication when scheduled
- Subject complies with all clinical trial instructions. Commits to all follow-up visits
Who cannot join
- had any other sexually transmitted disease or gynaecological abnormality requiring treatment
- had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
- were pregnant
- had used antifungal medication in the week before entry
- were expected to menstruate within seven days of the start of treatment
- infected more than one candida species
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Case-controlled Randomized Study to the Efficacy of Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs Fluconazole for the treatment of severe vulvovaginal candidiasis
Read the detailed description
The current study is evaluating both the efficacy and safety of the 2 doses of 500 mg clotrimazole vaginal tablet administered intravaginally( at day 1 and day 4) v.s 2 doses of 150 mg fluconazole( at day 1 and day 4) for treatment of severe vulvovaginal candidiasis.The number of participants with adverse events as a measure of safety and tolerability.
- Conditions
- Candidiasis, Vulvovaginal
- Being tested
- Clotrimazole vaginal tablet, Fluconazole
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clotrimazole vaginal tabletDrug
Also called Canesten
2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
FluconazoleDrug
Also called Diflucan
2 doses of 150 mg oral Fluconazole (at day1 and day4)
| Study group | Role | What they receive |
|---|---|---|
| Clotrimazole vaginal tablet | Experimental | 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) Receives: Drug: Clotrimazole vaginal tablet |
| Fluconazole | Active comparator | 2 doses of 150 mg oral Fluconazole (at day1 and day4) Receives: Drug: Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Efficacy 1
The clinical cure rates of clotrimazole and fluconazol: Clinical cure was defined as the resolution of symptoms present at baseline with a total severity score of ≤2. Improvement was defined as considerable reduction in the severity of baseline signs and symptoms with a decrease in the total score by ≥50%.Patients not clinically cured or showing improvement were considered clinical failures.
Measured: 7-14 days after treatment (=visit 2)
Therapeutic Efficacy 2
The clinical cure rates of clotrimazole and fluconazol
Measured: at days 30-35 follow-up
Therapeutic Efficacy 3
Mycological cure of clotrimazole group and fluconazole group
Measured: at days 7-14 follow-up
Therapeutic Efficacy 4
Mycological cure of clotrimazole group and fluconazole group: Mycological cure or failure was referred to as Candida negative or positive,respectively, on Candida culture at follow-up visits.
Measured: at days30-35 follow-up
Secondary outcomes (5)
Adverse Events 1
Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue.
Measured: at day 7-14 follow up
Adverse Events 2
Vulvovaginal pruritus, burning, irritation, and bleeding
Measured: at day 7-14 follow up
Adverse Events 3
Gastrointestinal tract: abdominal pain, diarrhoea, nausea
Measured: at day 7-14 follow up
Adverse Events 4
Skin sensitivity, urticaria rash, erythematous rash, irritation
Measured: at day 7-14 follow up
Total Adverse Events
Total adverse events(cases)
Measured: at day 7-14 follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2015
- Study completionSep 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Candidiasis, VulvovaginalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Shangrong Fan, Peking University Shenzhen Hospital
- Investigators
- Shangrong Fan, M.D., Principal investigator, Peking University Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180828
- Sponsor's protocol ID
- pkuszh-2014-02
- Status last verified
- Apr 2017
- First submitted
- 30 Jun 2014
- Last updated
- 2 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://onlinelibrary.wiley.com/doi/10.1111/myc.12485/epdf
Publications
Zhou X, Li T, Fan S, Zhu Y, Liu X, Guo X, Liang Y. The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis. Mycoses. 2016 Jul;59(7):419-28. doi: 10.1111/myc.12485. Epub 2016 Apr 13.
PubMed 27073145
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Case-controlled Randomized Study to the Efficacy of Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT02180828
- Acronym / sponsor ID
- pkuszh-2014-02
- Conditions
- Candidiasis, Vulvovaginal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Peking University Shenzhen HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Jul 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Jul 2014 (estimated)
- Results
- Posted 30 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs Fluconazole for the treatment of severe vulvovaginal candidiasis
Detailed description
The current study is evaluating both the efficacy and safety of the 2 doses of 500 mg clotrimazole vaginal tablet administered intravaginally( at day 1 and day 4) v.s 2 doses of 150 mg fluconazole( at day 1 and day 4) for treatment of severe vulvovaginal candidiasis.The number of participants with adverse events as a measure of safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clotrimazole vaginal tablet | Experimental | Drug: Clotrimazole vaginal tablet2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) |
| Fluconazole | Active comparator | Drug: Fluconazole2 doses of 150 mg oral Fluconazole (at day1 and day4) |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7
- Subject completes the informed consent process
- Subject agrees to take study medication when scheduled
- Subject complies with all clinical trial instructions. Commits to all follow-up visits
Key exclusion criteria (6 listed)
- had any other sexually transmitted disease or gynaecological abnormality requiring treatment
- had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
- were pregnant
- had used antifungal medication in the week before entry
- were expected to menstruate within seven days of the start of treatment
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 |
|---|---|---|
| Clotrimazole vaginal tabletAlso: Canesten2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) | Drug | Clotrimazole vaginal tablet |
| FluconazoleAlso: Diflucan2 doses of 150 mg oral Fluconazole (at day1 and day4) | Drug | Fluconazole |
Primary outcome
Therapeutic Efficacy 1
Time frame: 7-14 days after treatment (=visit 2)
The clinical cure rates of clotrimazole and fluconazol: Clinical cure was defined as the resolution of symptoms present at baseline with a total severity score of ≤2. Improvement was defined as considerable reduction in the severity of baseline signs and symptoms with a decrease in the total score by ≥50%.Patients not clinically cured or showing improvement were considered clinical failures.
Therapeutic Efficacy 2
Time frame: at days 30-35 follow-up
The clinical cure rates of clotrimazole and fluconazol
Therapeutic Efficacy 3
Time frame: at days 7-14 follow-up
Mycological cure of clotrimazole group and fluconazole group
Therapeutic Efficacy 4
Time frame: at days30-35 follow-up
Mycological cure of clotrimazole group and fluconazole group: Mycological cure or failure was referred to as Candida negative or positive,respectively, on Candida culture at follow-up visits.
5 secondary outcomes
Adverse Events 1
Time frame: at day 7-14 follow up
Adverse Events 2
Time frame: at day 7-14 follow up
Adverse Events 3
Time frame: at day 7-14 follow up
Adverse Events 4
Time frame: at day 7-14 follow up
Total Adverse Events
Time frame: at day 7-14 follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27073145Zhou X, Li T, Fan S, Zhu Y, Liu X, Guo X, Liang Y. The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis. Mycoses. 2016 Jul;59(7):419-28. doi: 10.1111/myc.12485. Epub 2016 Apr 13.
- Individual participant dataSharing planned: Yes. http://onlinelibrary.wiley.com/doi/10.1111/myc.12485/epdf
Related trials for Candidiasis, Vulvovaginal
Recruiting
Multi-Gyn FemiTotal for the Treatment and Prevention of Vulvovaginal Candidiasis Symptoms and Bacterial Vaginosis
Bacterial Vaginosis, Vaginal Candidiasis
RecruitingObservational study
Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Vulvovaginitis, Candidal, Vulvovaginal Candidiasis
Active, not recruitingObservational study
Comparative Performance of a Vaginal Yeast Test
Vulvovaginal Candidiasis
Active, not recruitingObservational study
DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy
Vulvovaginal Candidiasis
Not yet recruiting
Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment
Genitourinary Syndrome of Menopause (GSM), Bacterial Vaginosis
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.
Shangrong Fan, M.D. principal investigator
Peking University Shenzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clotrimazole vaginal tablet and Fluconazole in people with Candidiasis, Vulvovaginal, run by Peking University Shenzhen Hospital at 1 site in China.
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 4 inclusion and 6 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 2 May 2017. 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 China. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 30 Sep 2016). 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?
Therapeutic Efficacy 1 (time frame: 7-14 days after treatment (=visit 2)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02180828, which also lists 1 linked publication.
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 2 May 2017.