Bacterial Vaginosis (BV)Phase 3BVNCT07418957
Efficacy and Safety of Vaginal Lactobacillus Dual Probiotic Capsules in Bacterial Vaginosis
A Phase 3 study testing Vaginal Lactobacillus Dual Probiotic Capsules in people with Bacterial Vaginosis (BV), run by Guangdong Longchuangji Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Primary Objective: To confirm that the clinical cure rate of Vaginal Lactobacillus Dual Probiotic Capsules for bacterial vaginosis (BV) is superior to placebo at the 21-30 day post-treatment visit (Day 21 to Day 30). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Bacterial Vaginosis (BV)
- What is being tested?
- Vaginal Lactobacillus Dual Probiotic Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2024to 3 Jul 2025
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The subjects fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate in the study, and sign an informed consent form before the trial begins;
- Females aged ≥18 years and ≤50 years, with normal and regular menstrual cycles;
- Have a history of sexual activity, are willing to undergo vaginal medication, and agree to avoid using other intravaginal products (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) and sexual activity throughout the entire trial period;
- Clinically diagnosed with Bacterial Vaginosis (BV), requiring the simultaneous satisfaction of all four Amsel criteria:
- Positive clue cells;
- Positive amine (whiff) test;
Show all 9Show fewer
- Vaginal discharge pH > 4.5;
- Vaginal discharge is homogeneous, thin, and grayish-white in appearance.
- Nugent score ≥ 7 points.
Who cannot join
- Known allergy to any component of the investigational drug;
- Known current diagnosis of pelvic inflammatory disease, cervicitis, or acute urogenital tract infections;
- Presence of vulvovaginitis caused by other infectious etiologies, such as vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), aerobic vaginitis (AV score ≥3), gonorrhea, Chlamydia trachomatisinfection, etc.;
- Pelvic examination at screening reveals the presence of condyloma acuminata;
- History of complicated or recurrent VVC within 1 year prior to screening;
- Known diagnosis of uterine myoma or adenomyosis requiring interventional treatment, as judged by the investigator;
Show all 17Show fewer
- Vaginal speculum examination at screening shows significant vaginal mucosal injury (e.g., mucosal edema, ulceration, erosion);
- History of significant diseases involving the cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine, or psychiatric systems, which in the investigator's judgment may affect participant safety;
- Use of vaginal douching or other intravaginal treatments (e.g., products like Jie Er Yin, Jie Yin Kang) within 72 hours prior to dosing or anticipated use during the trial period;
- Received antibiotic or antifungal treatment (systemic and/or intravaginal) within 2 weeks prior to dosing;
- Current use of long-acting injectable contraceptives or long-acting oral contraceptives at screening;
- History of gynecological surgery or common procedures that may affect the vaginal microenvironment within 2 months prior to screening (including but not limited to Bartholin's cyst/abscess incision, intrauterine device removal/insertion, cervical or vaginal wall biopsy, cervical conization or loop electrosurgical excision procedure [LEEP]);
- Virological testing at screening is positive for syphilis or HIV;
- Positive pregnancy test at screening; or history of pregnancy termination within 2 months prior to screening; or women of childbearing potential who, in the investigator's judgment, cannot use a medically approved, reliable method of contraception from the time of signing the informed consent form until 3 months after the last dose of the study drug;
- Women who are pregnant or breastfeeding;
- Participation in other drug or device clinical trials within 3 months prior to dosing, involving the use of investigational drugs or devices;
- Any other medical condition that, in the investigator's judgment, may interfere with the assessment of this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University General Hospital
Tianjin, No. 154, Anshan Road, Heping District
About this study
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study on the Efficacy and Safety of Vaginal Lactobacillus Dual Probiotic Capsules for the Treatment of Bacterial Vaginosis
Primary Objective: To confirm that the clinical cure rate of Vaginal Lactobacillus Dual Probiotic Capsules for bacterial vaginosis (BV) is superior to placebo at the 21-30 day post-treatment visit (Day 21 to Day 30).
Key Secondary Objective: To compare the clinical cure rate of Vaginal Lactobacillus Dual Probiotic Capsules versus placebo for BV at the 15-18 day post-treatment visit (Day 15 to Day 18).
Read more
Other Secondary Objectives: 1) To comprehensively assess the therapeutic efficacy of the study drug versus placebo for BV at Day 15 to 18 and Day 21 to 30; 2) To evaluate the safety profile of the study drug for BV treatment compared with placebo, including adverse events and clinical laboratory findings.
Study Design \& Randomization: This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial. An independent biostatistician generated the subject and drug randomization lists via SAS software, which were imported into an Interactive Web Response System (IWRS). Investigators at each site obtain randomization and drug numbers through the IWRS for subject allocation.
Blinding \& Allocation Concealment: Double-blinding is implemented for both investigators and subjects. The study drug and placebo are identical in appearance, shape, specification, and dosage form. Blinding procedures are performed by personnel unrelated to the trial, with a complete and detailed record of the entire blinding process maintained throughout the study.
Read the detailed description
This Phase III clinical trial is designed to evaluate the superior efficacy and safety of Vaginal Lactobacillus Dual Probiotic Capsules for the treatment of bacterial vaginosis (BV) in adult women, with a placebo control and double-blind design to minimize bias in efficacy and safety assessment. BV is a common vaginal dysbiosis caused by the imbalance of vaginal microflora, characterized by the reduction of dominant Lactobacillus and overgrowth of anaerobic bacteria, and clinical treatment options with sustained efficacy and good safety are still in demand.
The study adopts a randomization mode based on an Interactive Web Response System (IWRS), which ensures the randomness and concealment of subject allocation. The randomization list is generated by an independent biostatistician using SAS statistical software, with no access to the list for on-site investigators to avoid selection bias. Strict double-blinding is maintained for the entire study period: the study drug and matching placebo are manufactured to be consistent in all physical characteristics, and the drug packaging and labeling are completed by professional personnel not involved in clinical trial implementation, follow-up, or assessment. The blinding code will be kept confidential and only unblinded in the event of a serious adverse event requiring urgent medical judgment, or after the completion of the entire study and database locking for statistical analysis.
Study interventions are administered intravaginally as per the trial protocol, with clinical efficacy assessed at two key time points: the early post-treatment visit (Day 15-18) to evaluate the short-term therapeutic effect, and the primary efficacy visit (Day 21-30) to confirm the sustained clinical cure effect-both core time points are set based on the natural course of BV and the metabolic characteristics of vaginal probiotics, to fully reflect the drug's regulatory effect on vaginal microflora. Efficacy assessment is based on the Amsel criteria (the gold standard for clinical diagnosis of BV) and Nugent score (quantitative microflora assessment), with consistent and standardized assessment criteria and operating procedures across all participating centers to ensure the comparability and reliability of efficacy data.
Safety assessment is conducted throughout the entire study period, including screening, treatment, and follow-up visits, with comprehensive collection of adverse events (AEs), serious adverse events (SAEs), physical examinations, gynecological specific examinations, and clinical laboratory tests (blood routine, urine routine, liver and kidney function, etc.). All safety data are recorded in the case report form (CRF) in a timely and accurate manner, and assessed for causality, severity, and relationship with the study drug by the investigator and clinical trial supervisor.
The multicenter design of the study ensures the representativeness of the study population, with participating centers selected for their rich clinical experience in the diagnosis and treatment of gynecological infectious diseases, and all investigators and research staff receive unified training and qualification confirmation before the trial initiation to ensure the standardization and consistency of trial implementation in accordance with the study protocol, Good Clinical Practice (GCP), and relevant regulatory requirements.
- Conditions
- Bacterial Vaginosis (BV)
- Being tested
- Vaginal Lactobacillus Dual Probiotic Capsules, Placebo
- Keywords
- Bacterial Vaginosis (BV)
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Lactobacillus Dual Probiotic CapsulesDrug
Investigational product for the treatment of BV, administered vaginally as per study protocol.
PlaceboOther
Placebo, matching the investigational product in appearance, dosage form, and route of administration, used as the control intervention in this double-blind, randomized trial.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Experimental | Vaginal Lactobacillus Dual Probiotic Capsules: Insert the capsule deep into the vagina. Administer one capsule twice daily (morning and evening) for 14 consecutive days. Receives: Drug: Vaginal Lactobacillus Dual Probiotic Capsules |
| Control Group | Placebo comparator | Placebo: Insert the capsule deep into the vagina. Administer one capsule twice daily (morning and evening) for 14 consecutive days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure Rate
Measured: Day 21 to Day 30
Secondary outcomes (9)
Clinical Cure Rate
Key secondary endpoint: Clinical Cure Rate at Day 15 to Day 18
Measured: Day 15 to Day 18
Rate of Nugent score<7
Rate of Nugent score<7
Measured: Day 15 to to Day 18
Rate of Nugent score<4
Rate of Nugent score<4
Measured: Day 15 to Day 18
Rate of Participants with Both Clinical Cure and Nugent Score < 7
Rate of Participants with Both Clinical Cure and Nugent Score < 7
Measured: Day 15 to Day 18
Rate of Participants with Both Clinical Cure and Nugent Score < 4
Rate of Participants with Both Clinical Cure and Nugent Score < 4
Measured: Day 15 to Day 18
Rate of Nugent score<7
Rate of Nugent score<7
Measured: Day 21 to Day 30
Rate of Nugent score<4
Rate of Nugent score<4
Measured: Day 21 to Day 30
Rate of Participants with Both Clinical Cure and Nugent Score < 7
Rate of Participants with Both Clinical Cure and Nugent Score < 7
Measured: Day 21 to Day 30
Rate of Participants with Both Clinical Cure and Nugent Score < 4
Rate of Participants with Both Clinical Cure and Nugent Score < 4
Measured: Day 21 to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start12 Jun 2024
- Primary completion17 May 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Vaginosis (BV)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment Group:Vaginal Lactobacillus Dual Probiotic Capsules: Insert the capsule deep into the vagina. Administer one capsule twice daily (morning and evening) for 14 consecutive days. Control Group:Placebo: Insert the capsule deep into the vagina. Administer one capsule twice daily (morning and evening) for 14 consecutive days.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Longchuangji Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fengxia F Xue, Study leader, Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418957
- Sponsor's protocol ID
- CTS-CO-2666
- Acronym
- BV
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 18 Feb 2026
- 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study on the Efficacy and Safety of Vaginal Lactobacillus Dual Probiotic Capsules for the Treatment of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT07418957
- Acronym / sponsor ID
- BV / CTS-CO-2666
- Conditions
- Bacterial Vaginosis (BV)
- Keywords
- Bacterial Vaginosis (BV)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Guangdong Longchuangji Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 17 May 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 18 Feb 2026 (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.
Primary Objective: To confirm that the clinical cure rate of Vaginal Lactobacillus Dual Probiotic Capsules for bacterial vaginosis (BV) is superior to placebo at the 21-30 day post-treatment visit (Day 21 to Day 30).
Key Secondary Objective: To compare the clinical cure rate of Vaginal Lactobacillus Dual Probiotic Capsules versus placebo for BV at the 15-18 day post-treatment visit (Day 15 to Day 18).
Other Secondary Objectives: 1) To comprehensively assess the therapeutic efficacy of the study drug versus placebo for BV at Day 15 to 18 and Day 21 to 30; 2) To evaluate the safety profile of the study drug for BV treatment compared with placebo, including adverse events and clinical laboratory findings.
Study Design \& Randomization: This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial. An independent biostatistician generated the subject and drug randomization lists via SAS software, which were imported into an Interactive Web Response System (IWRS). Investigators at each site obtain randomization and drug numbers through the IWRS for subject allocation.
Blinding \& Allocation Concealment: Double-blinding is implemented for both investigators and subjects. The study drug and placebo are identical in appearance, shape, specification, and dosage form. Blinding procedures are performed by personnel unrelated to the trial, with a complete and detailed record of the entire blinding process maintained throughout the study.
Detailed description
This Phase III clinical trial is designed to evaluate the superior efficacy and safety of Vaginal Lactobacillus Dual Probiotic Capsules for the treatment of bacterial vaginosis (BV) in adult women, with a placebo control and double-blind design to minimize bias in efficacy and safety assessment. BV is a common vaginal dysbiosis caused by the imbalance of vaginal microflora, characterized by the reduction of dominant Lactobacillus and overgrowth of anaerobic bacteria, and clinical treatment options with sustained efficacy and good safety are still in demand.
The study adopts a randomization mode based on an Interactive Web Response System (IWRS), which ensures the randomness and concealment of subject allocation. The randomization list is generated by an independent biostatistician using SAS statistical software, with no access to the list for on-site investigators to avoid selection bias. Strict double-blinding is maintained for the entire study period: the study drug and matching placebo are manufactured to be consistent in all physical characteristics, and the drug packaging and labeling are completed by professional personnel not involved in clinical trial implementation, follow-up, or assessment. The blinding code will be kept confidential and only unblinded in the event of a serious adverse event requiring urgent medical judgment, or after the completion of the entire study and database locking for statistical analysis.
Study interventions are administered intravaginally as per the trial protocol, with clinical efficacy assessed at two key time points: the early post-treatment visit (Day 15-18) to evaluate the short-term therapeutic effect, and the primary efficacy visit (Day 21-30) to confirm the sustained clinical cure effect-both core time points are set based on the natural course of BV and the metabolic characteristics of vaginal probiotics, to fully reflect the drug's regulatory effect on vaginal microflora. Efficacy assessment is based on the Amsel criteria (the gold standard for clinical diagnosis of BV) and Nugent score (quantitative microflora assessment), with consistent and standardized assessment criteria and operating procedures across all participating centers to ensure the comparability and reliability of efficacy data.
Safety assessment is conducted throughout the entire study period, including screening, treatment, and follow-up visits, with comprehensive collection of adverse events (AEs), serious adverse events (SAEs), physical examinations, gynecological specific examinations, and clinical laboratory tests (blood routine, urine routine, liver and kidney function, etc.). All safety data are recorded in the case report form (CRF) in a timely and accurate manner, and assessed for causality, severity, and relationship with the study drug by the investigator and clinical trial supervisor.
The multicenter design of the study ensures the representativeness of the study population, with participating centers selected for their rich clinical experience in the diagnosis and treatment of gynecological infectious diseases, and all investigators and research staff receive unified training and qualification confirmation before the trial initiation to ensure the standardization and consistency of trial implementation in accordance with the study protocol, Good Clinical Practice (GCP), and relevant regulatory requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Treatment Group:Vaginal Lactobacillus Dual Probiotic Capsules: Insert the capsule deep into the vagina. Administer one capsule twice daily (morning and evening) for 14 consecutive days. Control Group:Placebo: Insert the capsule deep into the vagina. Administer one capsule twice daily (morning and evening) for 14 consecutive days.
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Experimental | Drug: Vaginal Lactobacillus Dual Probiotic CapsulesVaginal Lactobacillus Dual Probiotic Capsules: Insert the capsule deep into the vagina. Administer one capsule twice daily (morning and evening) for 14 consecutive days. |
| Control Group | Placebo comparator | Other: PlaceboPlacebo: Insert the capsule deep into the vagina. Administer one capsule twice daily (morning and evening) for 14 consecutive days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- The subjects fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate in the study, and sign an informed consent form before the trial begins;
- Females aged ≥18 years and ≤50 years, with normal and regular menstrual cycles;
- Have a history of sexual activity, are willing to undergo vaginal medication, and agree to avoid using other intravaginal products (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) and sexual activity throughout the entire trial period;
- Clinically diagnosed with Bacterial Vaginosis (BV), requiring the simultaneous satisfaction of all four Amsel criteria:
- Nugent score ≥ 7 points.
Key exclusion criteria (17 listed)
- Known allergy to any component of the investigational drug;
- Known current diagnosis of pelvic inflammatory disease, cervicitis, or acute urogenital tract infections;
- Presence of vulvovaginitis caused by other infectious etiologies, such as vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), aerobic vaginitis (AV score ≥3), gonorrhea, Chlamydia trachomatisinfection, etc.;
- Pelvic examination at screening reveals the presence of condyloma acuminata;
- History of complicated or recurrent VVC within 1 year prior to screening;
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 |
|---|---|---|
| Vaginal Lactobacillus Dual Probiotic CapsulesInvestigational product for the treatment of BV, administered vaginally as per study protocol. | Drug | Probiotic Group |
| PlaceboPlacebo, matching the investigational product in appearance, dosage form, and route of administration, used as the control intervention in this double-blind, randomized trial. | Other | Control Group |
Primary outcome
Clinical Cure Rate
Time frame: Day 21 to Day 30
9 secondary outcomes
Clinical Cure Rate
Time frame: Day 15 to Day 18
Rate of Nugent score<7
Time frame: Day 15 to to Day 18
Rate of Nugent score<4
Time frame: Day 15 to Day 18
Rate of Participants with Both Clinical Cure and Nugent Score < 7
Time frame: Day 15 to Day 18
Rate of Participants with Both Clinical Cure and Nugent Score < 4
Time frame: Day 15 to Day 18
Rate of Nugent score<7
Time frame: Day 21 to Day 30
Rate of Nugent score<4
Time frame: Day 21 to Day 30
Rate of Participants with Both Clinical Cure and Nugent Score < 7
Time frame: Day 21 to Day 30
Rate of Participants with Both Clinical Cure and Nugent Score < 4
Time frame: Day 21 to Day 30
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 18 Feb 2026.
- 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.
Fengxia F Xue, Study leader principal investigator
Tianjin Medical University General Hospital
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 Vaginal Lactobacillus Dual Probiotic Capsules in people with Bacterial Vaginosis (BV), run by Guangdong Longchuangji Pharmaceutical 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 9 inclusion and 17 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 18 Feb 2026. 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. 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.
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?
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?
Clinical Cure Rate (time frame: Day 21 to Day 30). 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 18 Feb 2026.