Bacterial VaginosisPhase 4NCT06458543
Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age
A Phase 4 study testing Longidaza and Metronidazole 500 mg in people with Bacterial Vaginosis, run by I.M. Sechenov First Moscow State Medical University at 2 sites in Russia.
Trial summary
The purpose of this clinical trial is to study the efficacy of bovgialuronidase azoximere in the treatment and duration of recurrence-free course of bacterial vaginosis in women of reproductive age. The main questions it aims to answer are: Is bovgialuronidase azoximer able to destroy G. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Longidaza and Metronidazole 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Jun 2024to 1 Jun 2026
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The written informed consent of the patient to participate in the study;
- Age (18 - 45 years old);
- The established diagnosis of Bacterial vaginosis;
- Absence of pregnancy and lactation.
Who cannot join
- Refusal of the patient from further participation in the study;
- Lack of patient adherence to treatment;
- The occurrence of conditions and diseases related to the list of contraindications to the use of the studied drug during the study.
- The presence of Neisseria gonorrhoeae, Trichomonas vaginalis, confirmed by laboratory;
- The presence of contraindications to the use of the studied drug according to the instructions for the drug.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
LLC "Family polyclinic No. 4" Korolev
Korolyov, 141060
Leonid Spivak, MD, Prof., +7 (903) 749-05-97, leonid.spivak@gmail.com
Kseniya Rossolovskaya, +7 (980) 164-77-99, rossolovskaya_k_a@staff.sechenov.ru
- Recruiting
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, 119991
Leonid Spivak, MD, Prof., +7 (903) 749-05-97, leonid.spivak@gmail.com
Kseniya Rossolovskaya, +7 (980) 164-77-99, rossolovskaya_k_a@staff.sechenov.ru
About this study
Official title: Efficacy of Bovhyaluronidase Azoximer on Biofilms Destruction in the Urogenital Tract of the Patients With Reccurent Bacterial Vaginosis.
The purpose of this clinical trial is to study the efficacy of bovgialuronidase azoximere in the treatment and duration of recurrence-free course of bacterial vaginosis in women of reproductive age. The main questions it aims to answer are:
- Is bovgialuronidase azoximer able to destroy G. vaginalis associated biofilms of the vaginal epithelium
- use of bovgialuronidase azoximer together with Metronidazole increases the effectiveness of treatment of bacterial vaginosis.
- use of azoximers bovgialuronidase together with Metronidazole increases the duration of relapse-free course of bacterial vaginosis.
Read more
Participants in the experimental and control group will be:
- Amsel criteria assessment
- Colpotest-PH (vaginal acidity)
- aminotest with 10% KOH solution ("fish odor")
- microscopic examination of vaginal discharge
- Bacteriologic culture of vaginal discharge
- Polymerase chain reaction of epithelial cell scrapings from the vagina
- electron microscopy of vaginal epithelial cell scrapings
Participants in the main group will be given the drug Bovgialuronidase azoximer and Metronidazole.
Participants in the control group: Metronidazole.
Researchers will compare the experimental and control groups to see if there are differences after treatment in biofilm structure, treatment efficacy, and duration of recurrence-free survival.
Read the detailed description
Bacterial vaginosis is characterized by a decrease in the number of lactobacilli and the dominance of opportunistic anaerobic flora (primarily G.vaginalis, to a lesser extent Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.). Modern ideas of the pathogenesis of bacterial vaginosis consist in the formation of polymicrobial biofilms on the surface of the mucosa of the vaginal epithelium. Biofilms are a community of microorganisms of one or more species attached to the surface of a polymeric matrix. Biofilms are formed predominantly by G.vaginalis and to a lesser extent by other pathogens associated with bacterial vaginosis (Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.). Biofilm-associated bacterial vaginosis is characterized by increased resistance to pathogenetic therapy, the ability to evade defense mechanisms and prolonged persistence in the vaginal environment. These features of pathogenesis cause a high rate of recurrences and chronic course of bacterial vaginosis.
Thus, it is relevant to study in vivo the role of drug action on biofilms to destroy them in order to increase the effectiveness of antibacterial therapy and reduce the frequency of recurrences of bacterial vaginosis.
The standard and approved by the Ministry of Health of the Russian Federation method of treatment of bacterial vaginosis is Metronidazole.
The aim of this clinical trial is to investigate the efficacy of combination therapy with metronidazole and azoximera bovgialuronidase in the treatment and duration of relapse-free course of bacterial vaginosis in women of reproductive age compared with metronidazole monotherapy.
The main questions it aims to answer are:
- Is bovgialuronidase azoximer able to destroy G. vaginalis associated biofilms of the vaginal epithelium
- use of bovgialuronidase azoximer together with Metronidazole increases the effectiveness of treatment of bacterial vaginosis.
- use of azoximers bovgialuronidase together with Metronidazole increases the duration of relapse-free course of bacterial vaginosis.
Participants in the experimental and control group will be:
- Amsel criteria assessment
- Colpotest-PH (vaginal acidity)
- aminotest with 10% KOH solution ("fish odor")
- microscopic examination of vaginal discharge
- Bacteriologic culture of vaginal discharge
- Polymerase chain reaction of epithelial cell scrapings from the vagina
- electron microscopy of vaginal epithelial cell scrapings
Main group - patients with bacterial vaginosis receiving pathogenetic antibacterial therapy (Metronidazole) in combination with Bovgialuronidase azoximer.
Control group - patients with bacterial vaginosis receiving pathogenetic antibacterial therapy (Metronidazole) without Bovgialuronidase azoximer.
Researchers will compare the experimental and control groups to see if there are differences after treatment in biofilm structure, treatment efficacy, and duration of recurrence-free survival.
- Conditions
- Bacterial Vaginosis
- Being tested
- Longidaza, Metronidazole 500 mg
- Keywords
- Bacterial Vaginosis, biofilms, bovhyaluronidase azoximer, treatment
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LongidazaDrug
Also called Bovhyaluronidase azoximer
Bovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days
Metronidazole 500 mgDrug
Also called Metronidazol
Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental group includes 50 women of reproductive age (18 - 45 years old) with an established diagnosis of bacterial vaginosis.
Participants in the experimental group will be given the drug Bovgialuronidase azoximer and Metronidazole.
Bovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days Receives: Drug: Longidaza; Drug: Metronidazole 500 mg |
| Control | Active comparator | The control group includes 50 women of reproductive age (18 - 45 years old) with an established diagnosis of bacterial vaginosis.
Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days Receives: Drug: Metronidazole 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the number of relapses of bacterial vaginosis
Evaluated by clinical data (using Amsel criteria) and laboratory (microscopic examination - identification of "key cells")
The Amsel criteria include 4 parameters, each of which is scored as one point:
- gray/white/grayish-white vaginal discharge
- Vaginal acidity pH greater than 4.5 (colpotest pH)
- aminotest with 10% solution of potassium hydroxide KOH (appearance of "fishy", "rotten" odor)
- Presence of "key cell" in microscopic examination of vaginal discharge
The presence of 3 or more of the 4 criteria speaks in favor of the diagnosis of "bacterial vaginosis" 2 and less points - absence of "bacterial vaginosis"
Measured: 6 months after treatment
Secondary outcomes (4)
changes in biofilm structure according to electron microscopy data
Biofilms are a cooperation of microorganisms of one or more species that are incorporated into a polymeric matrix consisting of proteins, polysaccharides and nucleic acids. Electron microscopy allows to evaluate the structure of the biofilm, to distinguish between lactobacilli and anaerobes (G. vaginalis, Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.). The destructive effect of azoximers bovgialuronidase on biofilms leads to disruption of biofilm structure: formation of holes in its structure, reduction of its size (volume), release of bacteria from the biofilm structure. Metronidazole has a bactericidal effect on G. vaginalis, Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc., which is expressed in the reduction of CFU/ml.
Measured: 21 days after treatment
decrease in the severity of characteristic complaints in female patients with BV
The main complaints that patients with bacterial vaginosis present with are: vaginal discharge and unpleasant odor of vaginal discharge.
The Amsel criteria are used to objectively assess these complaints
The Amsel criteria include 4 parameters, each of which is scored as one point:
- gray/white/grayish-white vaginal discharge
- Vaginal acidity pH greater than 4.5 (colpotest pH)
- aminotest with 10% solution of potassium hydroxide KOH (appearance of "fishy", "rotten" odor)
- Presence of "key cell" in microscopic examination of vaginal discharge
The presence of 3 or more of the 4 criteria speaks in favor of the diagnosis of "bacterial vaginosis" 2 and less points - absence of "bacterial vaginosis"
After treatment the patient is expected to have no characteristic complaints
Measured: 21 days after treatment
Decreased vaginal acidity
Normally, the acidity of the vagina is 4.5 or less (рН=4,5 оr less), meaning the vagina has an acidic environment.
The pH is measured with the Kolpotest-PH rapid test. After applying vaginal discharge to the indicator screen of the test strip, it is colored. The color obtained is compared with the indicator scale placed on the Colpotest-pH jar. If the pH is 4.5 or less, it is normal.
A pH result greater than 4.5 favors a diagnosis of bacterial vaginosis After treatment is expected to normalize vaginal acidity (pH = 4.5 or less)
Measured: 21 days after treatment
Normalization of the composition of the microflora of the urogenital tract
Normally, the vagina of women of reproductive age is dominated by Lactobacilli (80-100%). A decrease in lactobacilli or their absence leads to the dominance of opportunistic microorganisms (e.g., G.vaginalis, Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.), which causes the appearance of complaints characteristic of bacterial vaginosis (vaginal discharge, unpleasant odor of vaginal discharge, itching, burning).
Microbiome is assessed by polymer chain reaction (Femoflor-16), which allows not only qualitative but also quantitative assessment of the composition of the vaginal microbiome.
After treatment, the number of opportunistic anaerobes is expected to decrease and the number of lactobacilli is expected to be dominant
Measured: 21 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonid Spivak, MD,Prof., Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)Kseniya Rossolovskaya, Study director, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458543
- Sponsor's protocol ID
- Longidaza IMSechenovMMA
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bovhyaluronidase Azoximer on Biofilms Destruction in the Urogenital Tract of the Patients With Reccurent Bacterial Vaginosis.
- ClinicalTrials.gov ID
- NCT06458543
- Acronym / sponsor ID
- Longidaza IMSechenovMMA
- Conditions
- Bacterial Vaginosis
- Keywords
- Bacterial Vaginosis, biofilms, bovhyaluronidase azoximer, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 13 Jun 2024 (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 clinical trial is to study the efficacy of bovgialuronidase azoximere in the treatment and duration of recurrence-free course of bacterial vaginosis in women of reproductive age. The main questions it aims to answer are:
- Is bovgialuronidase azoximer able to destroy G. vaginalis associated biofilms of the vaginal epithelium
- use of bovgialuronidase azoximer together with Metronidazole increases the effectiveness of treatment of bacterial vaginosis.
- use of azoximers bovgialuronidase together with Metronidazole increases the duration of relapse-free course of bacterial vaginosis.
Participants in the experimental and control group will be:
- Amsel criteria assessment
- Colpotest-PH (vaginal acidity)
- aminotest with 10% KOH solution ("fish odor")
- microscopic examination of vaginal discharge
- Bacteriologic culture of vaginal discharge
- Polymerase chain reaction of epithelial cell scrapings from the vagina
- electron microscopy of vaginal epithelial cell scrapings
Participants in the main group will be given the drug Bovgialuronidase azoximer and Metronidazole.
Participants in the control group: Metronidazole.
Researchers will compare the experimental and control groups to see if there are differences after treatment in biofilm structure, treatment efficacy, and duration of recurrence-free survival.
Detailed description
Bacterial vaginosis is characterized by a decrease in the number of lactobacilli and the dominance of opportunistic anaerobic flora (primarily G.vaginalis, to a lesser extent Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.). Modern ideas of the pathogenesis of bacterial vaginosis consist in the formation of polymicrobial biofilms on the surface of the mucosa of the vaginal epithelium. Biofilms are a community of microorganisms of one or more species attached to the surface of a polymeric matrix. Biofilms are formed predominantly by G.vaginalis and to a lesser extent by other pathogens associated with bacterial vaginosis (Atopobium vaginae, Peptostreptococcus, Clostridiales spp., Prevotella spp., etc.). Biofilm-associated bacterial vaginosis is characterized by increased resistance to pathogenetic therapy, the ability to evade defense mechanisms and prolonged persistence in the vaginal environment. These features of pathogenesis cause a high rate of recurrences and chronic course of bacterial vaginosis.
Thus, it is relevant to study in vivo the role of drug action on biofilms to destroy them in order to increase the effectiveness of antibacterial therapy and reduce the frequency of recurrences of bacterial vaginosis.
The standard and approved by the Ministry of Health of the Russian Federation method of treatment of bacterial vaginosis is Metronidazole.
The aim of this clinical trial is to investigate the efficacy of combination therapy with metronidazole and azoximera bovgialuronidase in the treatment and duration of relapse-free course of bacterial vaginosis in women of reproductive age compared with metronidazole monotherapy.
The main questions it aims to answer are:
- Is bovgialuronidase azoximer able to destroy G. vaginalis associated biofilms of the vaginal epithelium
- use of bovgialuronidase azoximer together with Metronidazole increases the effectiveness of treatment of bacterial vaginosis.
- use of azoximers bovgialuronidase together with Metronidazole increases the duration of relapse-free course of bacterial vaginosis.
Participants in the experimental and control group will be:
- Amsel criteria assessment
- Colpotest-PH (vaginal acidity)
- aminotest with 10% KOH solution ("fish odor")
- microscopic examination of vaginal discharge
- Bacteriologic culture of vaginal discharge
- Polymerase chain reaction of epithelial cell scrapings from the vagina
- electron microscopy of vaginal epithelial cell scrapings
Main group - patients with bacterial vaginosis receiving pathogenetic antibacterial therapy (Metronidazole) in combination with Bovgialuronidase azoximer.
Control group - patients with bacterial vaginosis receiving pathogenetic antibacterial therapy (Metronidazole) without Bovgialuronidase azoximer.
Researchers will compare the experimental and control groups to see if there are differences after treatment in biofilm structure, treatment efficacy, and duration of recurrence-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Longidaza, Drug: Metronidazole 500 mgThe experimental group includes 50 women of reproductive age (18 - 45 years old) with an established diagnosis of bacterial vaginosis. Participants in the experimental group will be given the drug Bovgialuronidase azoximer and Metronidazole. Bovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days |
| Control | Active comparator | Drug: Metronidazole 500 mgThe control group includes 50 women of reproductive age (18 - 45 years old) with an established diagnosis of bacterial vaginosis. Metronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The written informed consent of the patient to participate in the study;
- Age (18 - 45 years old);
- The established diagnosis of Bacterial vaginosis;
- Absence of pregnancy and lactation.
Key exclusion criteria (5 listed)
- Refusal of the patient from further participation in the study;
- Lack of patient adherence to treatment;
- The occurrence of conditions and diseases related to the list of contraindications to the use of the studied drug during the study.
- The presence of Neisseria gonorrhoeae, Trichomonas vaginalis, confirmed by laboratory;
- The presence of contraindications to the use of the studied drug according to the instructions for the drug.
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 |
|---|---|---|
| LongidazaAlso: Bovhyaluronidase azoximerBovhyaluronidase azoximer, vaginal suppositories 3000 IU, 1 suppository vaginally every other day, course of 10 days | Drug | Experimental |
| Metronidazole 500 mgAlso: MetronidazolMetronidazole, tablets 500 mg, 1 tablet 2 times a day, orally, course 7 days | Drug | Control, Experimental |
Primary outcome
Reduction in the number of relapses of bacterial vaginosis
Time frame: 6 months after treatment
Evaluated by clinical data (using Amsel criteria) and laboratory (microscopic examination - identification of "key cells") The Amsel criteria include 4 parameters, each of which is scored as one point: * gray/white/grayish-white vaginal discharge * Vaginal acidity pH greater than 4.5 (colpotest pH) * aminotest with 10% solution of potassium hydroxide KOH (appearance of "fishy", "rotten" odor) * Presence of "key cell" in microscopic examination of vaginal discharge The presence of 3 or more of the 4 criteria speaks in favor of the diagnosis of "bacterial vaginosis" 2 and less points - absence of "bacterial vaginosis"
4 secondary outcomes
changes in biofilm structure according to electron microscopy data
Time frame: 21 days after treatment
decrease in the severity of characteristic complaints in female patients with BV
Time frame: 21 days after treatment
Decreased vaginal acidity
Time frame: 21 days after treatment
Normalization of the composition of the microflora of the urogenital tract
Time frame: 21 days after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
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)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
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.
Leonid Spivak, MD,Prof. principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Kseniya Rossolovskaya study director
I.M. Sechenov First Moscow State Medical University (Sechenov University)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Longidaza and Metronidazole 500 mg in people with Bacterial Vaginosis, run by I.M. Sechenov First Moscow State Medical University at 2 sites in Russia.
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 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: status not confirmed, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonid Spivak, MD, Prof. (+7 (903) 749-05-97, leonid.spivak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the number of relapses of bacterial vaginosis (time frame: 6 months after treatment). 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 9 Apr 2025.