Acute Vulvovaginal CandidiasisPhase 3NCT04956419
A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
A Phase 3 study testing SHR8008 capsule and Fluconazole capsule in people with Acute Vulvovaginal Candidiasis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole In Subjects with Acute vulvovaginal Candidiasis Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Acute Vulvovaginal Candidiasis
- What is being tested?
- SHR8008 capsule and Fluconazole capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2021to 30 Sep 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females ≥18 and ≤75 years old;
- Clinical diagnosis with VVC episodes at screening, signs and symptoms score of ≥ 7, with a documented positive potassium hydroxide (KOH) or Gram staining;
- Subjects of childbearing potential must have a negative pregnancy test result at screening and agree to use highly effective contraceptive measures throughout the study;
- Willing to sign the informed consent form to participate in this study.
Who cannot join
- Have recurrent vulvovaginal candidiasis (RVVC) as defined by 4 or more confirmed VVC episodes in the past 12 months or history of RVVC;
- Presence of concomitant vulvovaginitis caused by other pathogens;
- History of cervical cancer, or "cervical intraepithelial neoplasia or malignancy" or "atypical squamous cells of undetermined significance (ASCUS)" as indicated by Pap test or other tests reported within 1 year before screening;
- Moderate to severe hepatic and/or renal disorders;
- Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, or vulvovaginal corticosteroids within 7 days prior to randomization;
- Have received any estrogen replacement therapy or vaginal topical products within 7 days prior to randomization;
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- Have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization;
- Presence of significant laboratory abnormalities at screening;
- QTc interval greater than 470 ms or other clinically significant ECG abnormalities at screening;
- Have planned surgeries or other medical procedures that may impact compliance with the protocol;
- Known history of hypersensitivity or intolerance to azole antifungal drugs;
- Being in the menstrual period, pregnant, or lactating at screening, or planning to become pregnant during the study period;
- History of narcotic or drug abuse or alcoholism within 6 months prior to screening;
- Have participated in another clinical study and received the investigational drug containing active ingredient within 30 days prior to screening;
- Other conditions unsuitable for participation in the study per investigator's judgment.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102200
About this study
Official title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Fluconazole Controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Acute Vulvovaginal Candidiasis (VVC)
The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole In Subjects with Acute vulvovaginal Candidiasis
- Conditions
- Acute Vulvovaginal Candidiasis
- Being tested
- SHR8008 capsule, Fluconazole capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR8008 capsuleDrug
once daily for 2 days(Day 1 and Day 2),oral
Fluconazole capsuleDrug
once daily for 2 days(Every 72 hours) ,oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | SHR8008 capsule Receives: Drug: SHR8008 capsule |
| Treatment group B | Active comparator | Fluconazole capsule Receives: Drug: Fluconazole capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with therapeutic cure
defined as absence of signs and symptoms of VVC plus negative culture of vaginal swabs for growth of Candida species
Measured: Day 28
Secondary outcomes (5)
The proportion of subjects therapeutic cure
Measured: Day 14
The proportion of subjects with clinical cure
defined as absence of signs and symptoms of VVC
Measured: Day 14 and Day 28
The proportion of subjects with mycological cure
defined as negative culture of vaginal swabs for growth of Candida species
Measured: Day 14 and Day 28
Changes from baseline in VVC signs and symptoms score
Measured: Day 14 and Day 28
The proportion of subjects receiving rescue therapy during the study
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start24 Apr 2021
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Fluconazole Controlled, Multicenter Phase III Clinical Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956419
- Sponsor's protocol ID
- SHR8008-302
- Status last verified
- Jul 2021
- First submitted
- 7 Jul 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Fluconazole Controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Acute Vulvovaginal Candidiasis (VVC)
- ClinicalTrials.gov ID
- NCT04956419
- Acronym / sponsor ID
- SHR8008-302
- Conditions
- Acute Vulvovaginal Candidiasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2021 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole In Subjects with Acute vulvovaginal Candidiasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Fluconazole Controlled, Multicenter Phase III Clinical Study
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR8008 capsuleSHR8008 capsule |
| Treatment group B | Active comparator | Drug: Fluconazole capsuleFluconazole capsule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females ≥18 and ≤75 years old;
- Clinical diagnosis with VVC episodes at screening, signs and symptoms score of ≥ 7, with a documented positive potassium hydroxide (KOH) or Gram staining;
- Subjects of childbearing potential must have a negative pregnancy test result at screening and agree to use highly effective contraceptive measures throughout the study;
- Willing to sign the informed consent form to participate in this study.
Key exclusion criteria (15 listed)
- Have recurrent vulvovaginal candidiasis (RVVC) as defined by 4 or more confirmed VVC episodes in the past 12 months or history of RVVC;
- Presence of concomitant vulvovaginitis caused by other pathogens;
- History of cervical cancer, or "cervical intraepithelial neoplasia or malignancy" or "atypical squamous cells of undetermined significance (ASCUS)" as indicated by Pap test or other tests reported within 1 year before screening;
- Moderate to severe hepatic and/or renal disorders;
- Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, or vulvovaginal corticosteroids within 7 days prior to randomization;
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 |
|---|---|---|
| SHR8008 capsuleonce daily for 2 days(Day 1 and Day 2),oral | Drug | Treatment group A |
| Fluconazole capsuleonce daily for 2 days(Every 72 hours) ,oral | Drug | Treatment group B |
Primary outcome
The proportion of subjects with therapeutic cure
Time frame: Day 28
defined as absence of signs and symptoms of VVC plus negative culture of vaginal swabs for growth of Candida species
5 secondary outcomes
The proportion of subjects therapeutic cure
Time frame: Day 14
The proportion of subjects with clinical cure
Time frame: Day 14 and Day 28
The proportion of subjects with mycological cure
Time frame: Day 14 and Day 28
Changes from baseline in VVC signs and symptoms score
Time frame: Day 14 and Day 28
The proportion of subjects receiving rescue therapy during the study
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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 3 study testing SHR8008 capsule and Fluconazole capsule in people with Acute Vulvovaginal Candidiasis, run by Jiangsu HengRui Medicine Co., Ltd. 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 15 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: status not confirmed, as of the sponsor's last update on 16 Sep 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 proportion of subjects with therapeutic cure (time frame: Day 28). 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 16 Sep 2021.