Vulvovaginal CandidiasisPhase 4NCT02180100
Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis
A Phase 4 study testing Terconazole Vaginal Suppository and Fluconazole in people with Vulvovaginal Candidiasis, run by Peking University Shenzhen Hospital at 1 site in China.
Trial summary
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Vulvovaginal Candidiasis
- What is being tested?
- Terconazole Vaginal Suppository and Fluconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Jun 2014
- 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
- Subject agrees to abstain from sexual intercourse from the time of randomization through the first seven days immediately following treatment
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
- had used antifungal medication in the week before entry; or
- 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: A Randomized, Parallel-group Study of Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.
Read the detailed description
This study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppository 80 mg inserted intravaginally once daily before bedtime for 6 consecutive days and oral fluconazole 150mg at day 1 and day 4 in the treatment of subjects with severe vulvovaginal candidiasis.
- Conditions
- Vulvovaginal Candidiasis
- Being tested
- Terconazole Vaginal Suppository, 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.
Terconazole Vaginal SuppositoryDrug
Also called Tekangzuo Yindao Shuan
Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
FluconazoleDrug
Also called Diflucan
orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
| Study group | Role | What they receive |
|---|---|---|
| Terconazole Vaginal Suppository | Experimental | Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days Receives: Drug: Terconazole Vaginal Suppository |
| Fluconazole | Active comparator | orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4. Receives: Drug: Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mycological Cure 1
Based on candida culture
Measured: Between day 7-14 after treatment, an average of 10 days
Secondary outcomes (1)
Mycological Cure 2
Based on Candida culture
Measured: Between day 28-35 after treatment, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startAug 2013
- Primary completionJun 2014
- Study completionJun 2014
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Shyndec Pharmaceutical Co., Ltd.
- 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
- NCT02180100
- Sponsor's protocol ID
- PKUSH-GNY-2013-01
- Status last verified
- Oct 2020
- First submitted
- 30 Jun 2014
- Last updated
- 23 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Li T, Zhu Y, Fan S, Liu X, Xu H, Liang Y. A randomized clinical trial of the efficacy and safety of terconazole vaginal suppository versus oral fluconazole for treating severe vulvovaginal candidiasis. Med Mycol. 2015 Jun;53(5):455-61. doi: 10.1093/mmy/myv017. Epub 2015 Apr 15.
PubMed 25877666
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-group Study of Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe
- ClinicalTrials.gov ID
- NCT02180100
- Acronym / sponsor ID
- PKUSH-GNY-2013-01
- Conditions
- Vulvovaginal Candidiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Peking University Shenzhen HospitalUniversity, hospital or other
- Collaborators
- Shanghai Shyndec Pharmaceutical Co., Ltd.
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Posted 23 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.
Detailed description
This study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppository 80 mg inserted intravaginally once daily before bedtime for 6 consecutive days and oral fluconazole 150mg at day 1 and day 4 in the treatment of subjects with severe vulvovaginal candidiasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terconazole Vaginal Suppository | Experimental | Drug: Terconazole Vaginal SuppositoryTerconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days |
| Fluconazole | Active comparator | Drug: Fluconazoleorally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 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
- Subject agrees to abstain from sexual intercourse from the time of randomization through the first seven days immediately following treatment
Key exclusion criteria (5 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
- had used antifungal medication in the week before entry; or
- were expected to menstruate within seven days of the start of treatment
- infected more than one candida species
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 |
|---|---|---|
| Terconazole Vaginal SuppositoryAlso: Tekangzuo Yindao ShuanTerconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days | Drug | Terconazole Vaginal Suppository |
| FluconazoleAlso: Diflucanorally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4. | Drug | Fluconazole |
Primary outcome
Mycological Cure 1
Time frame: Between day 7-14 after treatment, an average of 10 days
Based on candida culture
1 secondary outcome
Mycological Cure 2
Time frame: Between day 28-35 after treatment, an average of 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25877666Li T, Zhu Y, Fan S, Liu X, Xu H, Liang Y. A randomized clinical trial of the efficacy and safety of terconazole vaginal suppository versus oral fluconazole for treating severe vulvovaginal candidiasis. Med Mycol. 2015 Jun;53(5):455-61. doi: 10.1093/mmy/myv017. Epub 2015 Apr 15.
- Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal CandidiasisLink provided by the sponsor.
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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.
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 Terconazole Vaginal Suppository and Fluconazole in people with Vulvovaginal Candidiasis, 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 5 inclusion and 5 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 23 Oct 2020. 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 23 Oct 2020). 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?
Mycological Cure 1 (time frame: Between day 7-14 after treatment, an average of 10 days). 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 NCT02180100, 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 23 Oct 2020.