Bacterial VaginosisPhase 2NCT07483671
Efficacy and Safety Study of BPR-101 Capsules in Combination With Metronidazole in BV Patients
A Phase 2 study testing BPR-101 capsules:Investigational product for the treatment of BV in people with Bacterial Vaginosis, run by Chengdu Syncor Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This trial employed a multicenter, randomized, double-blind, parallel, placebo-controlled design to evaluate the preventive effect of BPR-101 capsules combined with metronidazole on the recurrence of BV, as well as the cure rate and safety. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- BPR-101 capsules:Investigational product for the treatment of BV
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2026to 24 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Females aged ≥18 years and ≤50 years, of childbearing age with a history of sexual activity;
- Clinically diagnosed with Bacterial Vaginosis (BV), this test requires meeting at least 3 of the following 4 Amsel criteria (with a positive clue cell test being a mandatory condition): positive clue cells; positive amine test; vaginal discharge pH > 4.5; and Vaginal discharge is homogeneous, thin, and grayish-white in appearance；
- Nugent score ≥ 7 points；
- Vaginal administration is acceptable, and the patient agrees to avoid using any other vaginal products (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) except as specified in the trial throughout the entire trial period；
- Researchers have assessed that the menstrual cycle is regular;
- Subjects must voluntarily sign a written informed consent form before the trial, understand the procedures and methods of the trial, and be willing to strictly abide by the clinical trial protocol and complete the trial.
Who cannot join
- Currently suffering from pelvic inflammatory disease, acute cervicitis, and urinary tract infection requiring intervention, among other acute infections of the genitourinary system;
- Presence of vulvovaginitis caused by other pathogens, which researchers considered to affect trial evaluation, such as aerobic vaginitis (AV), vulvovaginal candidiasis (VVC), and trichomoniasis；
- Currently, other vaginal or vulvar diseases are considered by researchers to affect the evaluation of the trial, such as human papillomavirus infection; or gynecological examinations showing condyloma acuminata or genital herpes；
- Unexplained abnormal vaginal bleeding within 6 months prior to screening or during the screening visit;
- Those who currently have uterine fibroids, endometrial hyperplasia, endometriosis, or adenomyosis, and for whom researchers believe that intervention is necessary during the trial;
- Received local or systemic antifungal or antibiotic treatment or probiotic treatment within 2 weeks prior to screening; or vaginal douching or other vaginal treatments (such as Jieeryin, Jieyinkang, etc.) within 1 week prior to screening, and/or expected to receive the above treatments during the trial;
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- Used systemic steroids (oral or injectable), disulfiram, lithium salts within 14 days prior to screening., and/or expected to receive such treatment during the trial;
- Currently using and/or expected to require cimetidine, warfarin (or other anticoagulation therapy) during the trial;
- Products containing alcohol or propylene glycol that are expected to be used within 3 days prior to screening and/or during the trial period;
- Hhistory of malignant tumors within 5 years prior to screening and deemed unsuitable for inclusion by the researchers, except for those with adequately treated basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ;
- Hhistory of major gynecological surgery within 6 months prior to screening(deep wounds, long recovery time), or superficial gynecological surgery or common procedures within 60 days prior to screening，or whose screening visit is within 60 days of their last termination of pregnancy;
- History of or currently suffering from serious diseases of the cardiovascular, liver, kidney, lung, digestive tract, nervous and mental system, genitourinary system, endocrine system, etc., and are deemed unsuitable for inclusion by the researchers;
- Laboratory tests meeting any of the following criteria, and the investigator deems them unsuitable for inclusion: serum creatinine > 1.5 times the upper limit of normal (ULN); urea/urea nitrogen > 1.5 ULN; alanine aminotransferase (ALT) > 2 ULN; aspartate aminotransferase (AST) > 2 ULN;
- Known hypersensitivity to any component of BPR-101 capsules or to other similar drugs (such as Live Lactobacillus Capsule for Vaginal Use ); or nitroimidazole, metronidazole, or any of the excipients；
- Women who are pregnant or breastfeeding, or whose pregnancy test results are positive, or who plan to become pregnant throughout the trial and within 3 months after the last dose; or who cannot accept the use of reliable contraception (absence of sexual intercourse or barrier contraception with condoms throughout the study period);
- Participated in other drug or device clinical trials within 1 month prior to screening and have used the investigational drug or device;
- The researchers believe that the subject has any other circumstances that would make them unsuitable to participate in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University General Hospital
Tianjin, 300000
FengXia Xue, 15922125459, fengxiaxue1962@163.com
FengXia Xue, Doctor of Medicine(M.D.)
About this study
Official title: A Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of BPR-101 Capsules in Combination With Metronidazole for the Prevention of Recurrence of Bacterial Vaginosis (BV).
This trial employed a multicenter, randomized, double-blind, parallel, placebo-controlled design to evaluate the preventive effect of BPR-101 capsules combined with metronidazole on the recurrence of BV, as well as the cure rate and safety.
- Conditions
- Bacterial Vaginosis
- Being tested
- BPR-101 capsules:Investigational product for the treatment of BV, Placebo：matching the investigational product in appearance, dosage form, and route of administration
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPR-101 capsules:Investigational product for the treatment of BVDrug
administered vaginally and orally as per study protocol.
Placebo：matching the investigational product in appearance, dosage form, and route of administrationOther
administered vaginally and orally as per study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Experimental | Capsules: Insert the capsule deep into the vagina. Metronidazole: Oral administration. Receives: Drug: BPR-101 capsules:Investigational product for the treatment of BV |
| Control Group | Placebo comparator | Capsules: Insert the capsule deep into the vagina. Metronidazole: Oral administration. Receives: Other: Placebo：matching the investigational product in appearance, dosage form, and route of administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence rate of BV
Nugent score + Amsel's test; any positive result indicates a relapse
Measured: Day 90
Secondary outcomes (5)
The recurrence rate of BV
Measured: Day 25 and 60
The cure rate of BV
Measured: Day 15
The recurrence rate of BV in cured patients
Measured: Day 90
The time from the last dose of trial medication to the first recurrence of BV
Measured: From the last dose of medication in the trial to the first recurrence of BV
Adverse events and serious adverse events, vital sign measurements, physical examination, gynecological examination, and laboratory test results (including blood/urine pregnancy test, complete blood count, blood biochemistry, and urinalysis).
Measured: Throughout the research period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion24 Jan 2027 (estimated)
- Study completion24 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Syncor Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- FengXia Xue, Doctor of Medicine(M.D.), Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483671
- Sponsor's protocol ID
- BT-BPR-101-IIb
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 19 Mar 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of BPR-101 Capsules in Combination With Metronidazole for the Prevention of Recurrence of Bacterial Vaginosis (BV).
- ClinicalTrials.gov ID
- NCT07483671
- Acronym / sponsor ID
- BT-BPR-101-IIb
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chengdu Syncor Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 24 Jan 2027 (estimated)
- Study completion
- 24 Jan 2027 (estimated)
- First posted
- 19 Mar 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.
This trial employed a multicenter, randomized, double-blind, parallel, placebo-controlled design to evaluate the preventive effect of BPR-101 capsules combined with metronidazole on the recurrence of BV, as well as the cure rate and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Experimental | Drug: BPR-101 capsules:Investigational product for the treatment of BVCapsules: Insert the capsule deep into the vagina. Metronidazole: Oral administration. |
| Control Group | Placebo comparator | Other: Placebo：matching the investigational product in appearance, dosage form, and route of administrationCapsules: Insert the capsule deep into the vagina. Metronidazole: Oral administration. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Females aged ≥18 years and ≤50 years, of childbearing age with a history of sexual activity;
- Clinically diagnosed with Bacterial Vaginosis (BV), this test requires meeting at least 3 of the following 4 Amsel criteria (with a positive clue cell test being a mandatory condition): positive clue cells; positive amine test; vaginal discharge pH > 4.5; and Vaginal discharge is homogeneous, thin, and grayish-white in appearance；
- Nugent score ≥ 7 points；
- Vaginal administration is acceptable, and the patient agrees to avoid using any other vaginal products (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) except as specified in the trial throughout the entire trial period；
- Researchers have assessed that the menstrual cycle is regular;
Key exclusion criteria (17 listed)
- Currently suffering from pelvic inflammatory disease, acute cervicitis, and urinary tract infection requiring intervention, among other acute infections of the genitourinary system;
- Presence of vulvovaginitis caused by other pathogens, which researchers considered to affect trial evaluation, such as aerobic vaginitis (AV), vulvovaginal candidiasis (VVC), and trichomoniasis；
- Currently, other vaginal or vulvar diseases are considered by researchers to affect the evaluation of the trial, such as human papillomavirus infection; or gynecological examinations showing condyloma acuminata or genital herpes；
- Unexplained abnormal vaginal bleeding within 6 months prior to screening or during the screening visit;
- Those who currently have uterine fibroids, endometrial hyperplasia, endometriosis, or adenomyosis, and for whom researchers believe that intervention is necessary during the trial;
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 |
|---|---|---|
| BPR-101 capsules:Investigational product for the treatment of BVadministered vaginally and orally as per study protocol. | Drug | Probiotic Group |
| Placebo：matching the investigational product in appearance, dosage form, and route of administrationadministered vaginally and orally as per study protocol. | Other | Control Group |
Primary outcome
The recurrence rate of BV
Time frame: Day 90
Nugent score + Amsel's test; any positive result indicates a relapse
5 secondary outcomes
The recurrence rate of BV
Time frame: Day 25 and 60
The cure rate of BV
Time frame: Day 15
The recurrence rate of BV in cured patients
Time frame: Day 90
The time from the last dose of trial medication to the first recurrence of BV
Time frame: From the last dose of medication in the trial to the first recurrence of BV
Adverse events and serious adverse events, vital sign measurements, physical examination, gynecological examination, and laboratory test results (including blood/urine pregnancy test, complete blood count, blood biochemistry, and urinalysis).
Time frame: Throughout the research period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Bacterial Vaginosis
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WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
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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.
FengXia Xue, Doctor of Medicine(M.D.) 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 2 study testing BPR-101 capsules:Investigational product for the treatment of BV in people with Bacterial Vaginosis, run by Chengdu Syncor 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 6 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: opening soon, as of the sponsor's last update on 19 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ke Yao (028-85142721, ke.yao@btyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recurrence rate of BV (time frame: Day 90). 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 19 Mar 2026.