Recurrent Vulvovaginal CandidiasisPhase 4NCT04699240
Study of Lactobacillus in Adjuvant Treatment of RVVC
A Phase 4 study testing clotrimazole vaginal tablets and Clotrimazole vaginal tablets+ Lactobacillus in people with Recurrent Vulvovaginal Candidiasis, run by Peking University Shenzhen Hospital at 1 site in China.
Trial summary
We are trying to determine if Clotrimazole vaginal tablets with oral Lactobacillus is better than Clotrimazole vaginal tablets in Preventing the Recurrence of vulvovaginalcandidiasis Read more about this study
- Who is it for?
- Ages 18 to 52 years, women only
- Conditions the study is for
- Recurrent Vulvovaginal Candidiasis
- What is being tested?
- clotrimazole vaginal tablets and Clotrimazole vaginal tablets+ Lactobacillus
- 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
- 1 Jul 2020to 30 Dec 2023
- Phase
- Phase 4
- 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 52 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women be at least 18 years of age
- Have symptoms of vulva irritation and or abnormal discharge
- Meet the clinical criteria for RVVC
- Willing to participate in research
Who cannot join
- Taking / injecting antibiotics in the past two weeks;
- A woman who intends to be pregnant, pregnant or lactating;
- Long term use of contraceptives and immunosuppressants;
- Postmenopausal;
- There was no same fixed sexual partner (RSP) before and after treatment
- Patients with severe gastrointestinal diseases, including colorectal cancer, IBS, IBD, chronic or acute diarrhea, long-term constipation, etc., or receiving gastrointestinal surgery and abdominal surgery within one year, such as cholecystectomy;
- Patients with severe heart, liver and kidney dysfunction, mental diseases, infectious diseases, tumors, severe anemia, and severe autoimmune diseases (such as rheumatoid arthritis, lupus erythematosus, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Case-controlled Randomized Study of Human Reproductive Tract Active Lactobacillus in Adjuvant Treatment of Recurrent Vulvovaginal Candidiasis.
We are trying to determine if Clotrimazole vaginal tablets with oral Lactobacillus is better than Clotrimazole vaginal tablets in Preventing the Recurrence of vulvovaginalcandidiasis
Read the detailed description
vulvovaginal candidiasis is common disease in women. Its refractory and high recurrence rate has always been a clinical problem. Some cases even recur several times a year, and those who recur more than four times a year are diagnosed as recurrent vaginal candidal infection Candidiasis, RVVC）。 The common clinical regimen for VVC is to strengthen and consolidate clotrimazole vaginal tablets for up to 25 weeks. However, long-term antibiotic treatment will lead to the decrease of vaginal microflora and the disappearance of inflammation and pathogenic bacteria, which will greatly increase the probability of repeated infection and become a barrier to clinical treatment. If probiotics are added in the treatment, the abundance of lactobacillus can be ensured while antibiotic treatment is carried out, the homeostasis of reproductive tract flora can be reestablished, the defense mechanism can be improved fundamentally, and the re invasion of pathogenic bacteria can be reduced, which will become a new treatment idea and method for radical cure of refractory RVVC.
We hypothesize that Clotrimazole vaginal tablets with oral Lactobacillus is better than Clotrimazole vaginal tablets in Preventing the Recurrence of vulvovaginalcandidiasis.
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Being tested
- clotrimazole vaginal tablets, Clotrimazole vaginal tablets+ Lactobacillus
- Keywords
- Recurrent Vulvovaginal Candidiasis, Lactobacillus, reproductive tract flora
- 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 tabletsDrug
Also called clotrimazole vaginal tablets（Bayer）
Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months
Clotrimazole vaginal tablets+ LactobacillusDrug
Also called Clotrimazole vaginal tablets+ Lactobacillus（Umeta-mimi）
Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months Human Reproductive Tract Active Lactobacillus,4g,qd ,3months
| Study group | Role | What they receive |
|---|---|---|
| Clotrimazole vaginal tablets | Active comparator | Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months Receives: Drug: clotrimazole vaginal tablets |
| Clotrimazole vaginal tablets+ Lactobacillus | Active comparator | Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times + Lactobacillus Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months Receives: Drug: Clotrimazole vaginal tablets+ Lactobacillus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cure rate of RVVC,
The cure rate of RVVC,
Measured: 6 months
Secondary outcomes (1)
Recurrence of RVVC
Recurrence of RVVC
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 Jul 2020
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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
- 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
- NCT04699240
- Sponsor's protocol ID
- pkuszh-2020-02
- Status last verified
- Jun 2025
- First submitted
- 5 Jan 2021
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Case-controlled Randomized Study of Human Reproductive Tract Active Lactobacillus in Adjuvant Treatment of Recurrent Vulvovaginal Candidiasis.
- ClinicalTrials.gov ID
- NCT04699240
- Acronym / sponsor ID
- pkuszh-2020-02
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Keywords
- Recurrent Vulvovaginal Candidiasis, Lactobacillus, reproductive tract flora
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Peking University Shenzhen HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 7 Jan 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.
We are trying to determine if Clotrimazole vaginal tablets with oral Lactobacillus is better than Clotrimazole vaginal tablets in Preventing the Recurrence of vulvovaginalcandidiasis
Detailed description
vulvovaginal candidiasis is common disease in women. Its refractory and high recurrence rate has always been a clinical problem. Some cases even recur several times a year, and those who recur more than four times a year are diagnosed as recurrent vaginal candidal infection Candidiasis, RVVC）。 The common clinical regimen for VVC is to strengthen and consolidate clotrimazole vaginal tablets for up to 25 weeks. However, long-term antibiotic treatment will lead to the decrease of vaginal microflora and the disappearance of inflammation and pathogenic bacteria, which will greatly increase the probability of repeated infection and become a barrier to clinical treatment. If probiotics are added in the treatment, the abundance of lactobacillus can be ensured while antibiotic treatment is carried out, the homeostasis of reproductive tract flora can be reestablished, the defense mechanism can be improved fundamentally, and the re invasion of pathogenic bacteria can be reduced, which will become a new treatment idea and method for radical cure of refractory RVVC.
We hypothesize that Clotrimazole vaginal tablets with oral Lactobacillus is better than Clotrimazole vaginal tablets in Preventing the Recurrence of vulvovaginalcandidiasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clotrimazole vaginal tablets | Active comparator | Drug: clotrimazole vaginal tabletsIntensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months |
| Clotrimazole vaginal tablets+ Lactobacillus | Active comparator | Drug: Clotrimazole vaginal tablets+ LactobacillusIntensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times + Lactobacillus Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women be at least 18 years of age
- Have symptoms of vulva irritation and or abnormal discharge
- Meet the clinical criteria for RVVC
- Willing to participate in research
Key exclusion criteria (7 listed)
- Taking / injecting antibiotics in the past two weeks;
- A woman who intends to be pregnant, pregnant or lactating;
- Long term use of contraceptives and immunosuppressants;
- Postmenopausal;
- There was no same fixed sexual partner (RSP) before and after 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 tabletsAlso: clotrimazole vaginal tablets（Bayer）Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months | Drug | Clotrimazole vaginal tablets |
| Clotrimazole vaginal tablets+ LactobacillusAlso: Clotrimazole vaginal tablets+ Lactobacillus（Umeta-mimi）Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months Human Reproductive Tract Active Lactobacillus,4g,qd ,3months | Drug | Clotrimazole vaginal tablets+ Lactobacillus |
Primary outcome
The cure rate of RVVC,
Time frame: 6 months
The cure rate of RVVC,
1 secondary outcome
Recurrence of RVVC
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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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 clotrimazole vaginal tablets and Clotrimazole vaginal tablets+ Lactobacillus in people with Recurrent 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 4 inclusion and 7 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 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 cure rate of RVVC, (time frame: 6 months). 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 Jun 2025.