Recurrent Bacterial VaginosisPhase 2/3NCT05033743
Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study
A Phase 2/3 study testing Secnidazole 2 GM Oral Granules in people with Recurrent Bacterial Vaginosis, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness Secnidazole to treat recurrent BV. Secnidazole is approved for one-time use in acute BV. In this study, the drug will be used for recurrent BV, and given weekly for 18 weeks. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Recurrent Bacterial Vaginosis
- What is being tested?
- Secnidazole 2 GM Oral Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2021to 7 Oct 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ability to consent in English
- Current symptomatic bacterial vaginosis infection
- History of at least 2 previous episodes of bacterial vaginosis in the past year
Who cannot join
- Current gynecologic infection or condition, including candida vaginitis, gonorrhea, chlamydia, trichomonas, desquamative inflammatory vaginitis, atrophic vaginitis.
- Pre-existing heart conditions
- Pre-existing neurological conditions
- Currently Pregnant or breastfeeding
- Women taking anticoagulants, lithium, metoclopramide, or disulfiram therapy
- Hypersensitivity to secnidazole or other drugs in the same class.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital - Coleman Center for Women
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to test the effectiveness Secnidazole to treat recurrent BV. Secnidazole is approved for one-time use in acute BV. In this study, the drug will be used for recurrent BV, and given weekly for 18 weeks.
Read the detailed description
A single-center prospective pilot study with once-weekly oral secnidazole granule treatment of acute condition for two-weeks followed by prophylactic treatment of asymptomatic responders with once-weekly secnidazole for 16 weeks, followed by no therapy for 12 weeks. The final follow-up evaluation is at week 28.
Eligible women with a current symptomatic bacterial vaginosis infection (> or = 3 Amsel criteria) and a history of at least 2 previous episodes of bacterial vaginosis in the past year will be enrolled in the open-label treatment study. All women will be treated with 2g of secnidazole granules orally once-weekly for 2 weeks. At the second visit, 3-5 days after completion of treatment, women who have a resolution of bacterial vaginosis (asymptomatic and < or = 2 Amsel criteria) will continue on once-weekly secnidazole for 16 weeks.
Patients will be evaluated every 4 weeks for recurrence of bacterial vaginosis. This will include questions about symptoms as well as a pelvic examination for assessment of vaginal discharge (> or = 3 Amsel criteria). We will also collect any information on other clinical evaluations for recurrence and the dates of diagnoses and types of treatments they may have received. Those who remain without recurrence during the 16-week suppressive phase will be followed for an additional 12 weeks off therapy, with assessment for recurrence at weeks 22 and 30. Throughout the study, data will be collected on participants' compliance and on the occurrence of adverse events.
- Conditions
- Recurrent Bacterial Vaginosis
- Being tested
- Secnidazole 2 GM Oral Granules
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secnidazole 2 GM Oral GranulesDrug
Once weekly 2g oral secnidazole for 18 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Secnidazole treatment Receives: Drug: Secnidazole 2 GM Oral Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With at Least One Episode of Bacterial Vaginosis
Overall failure rate as measured by the number of subjects with at least one episode of bacterial vaginosis in the 30 week follow-up period.
Measured: 30 weeks
Probability of Failure at 210 Days
To assess the efficacy of secnidazole, we estimated failure rates and 95% exact confidence intervals for initial treatment, suppression therapy following initial resolution of BV symptoms, and overall. For the time-to-failure analysis, time was defined as the number of days since the second visit where clinical resolution of initial BV was confirmed. The non-parametric maximum likelihood estimate (NPMLE) of the survival curve was estimated using the interval package in R to account for the interval censored data. Results are presented using an Amsel criteria score of as well as for BV diagnosis. All analyses were conducted using R 4.2.2 (R Core Team, 2020) in RStudio (RStudio Team 2021).
Measured: 210 days (30 weeks)
The Number of Subjects That Failed Treatment in the Supressive Phase
The probability of recurrence or treatment failure was calculated as time from the second visit in days. This timeframe is the suppressive therapy phase and was 30 weeks long.
Measured: 30 weeks
Secondary outcomes (7)
Number of Subjects Who Experienced Recurrence 3-5 Days After Initial Treatment (Initial Treatment Was 2 Weeks Long)
Recurrence was measured using the Amsel criteria. The Amsel criteria are: 1) Homogenous white discharge, 2) pH > 4.5, 3) amine odor (whiff) test, 4) clue cells on microscopy
Measured: 3-5 days after initial treatment after initial treatment of 2 weeks
Number of Subjects Who Experienced Recurrence 6 Weeks After Start of Initial Treatment
Recurrence was measured using the Amsel criteria. The Amsel criteria are: 1) Homogenous white discharge, 2) pH > 4.5, 3) amine odor (whiff) test, 4) clue cells on microscopy
Measured: week 6
Number of Subjects Who Experienced Recurrence 10 Weeks After Start of Initial Treatment
Recurrence was measured using the Amsel criteria. The Amsel criteria are: 1) Homogenous white discharge, 2) pH > 4.5, 3) amine odor (whiff) test, 4) clue cells on microscopy
Measured: week 10
Number of Subjects Who Experienced Recurrence 14 Weeks After Start of Initial Treatment
Recurrence was measured using the Amsel criteria. The Amsel criteria are: 1) Homogenous white discharge, 2) pH > 4.5, 3) amine odor (whiff) test, 4) clue cells on microscopy
Measured: week 14
Number of Subjects Who Experienced Recurrence 18 Weeks After Start of Initial Treatment
Recurrence was measured using the Amsel criteria. The Amsel criteria are: 1) Homogenous white discharge, 2) pH > 4.5, 3) amine odor (whiff) test, 4) clue cells on microscopy
Measured: week 18
Number of Subjects Who Experienced Recurrence 22 Weeks After Start of Initial Treatment
Recurrence was measured using the Amsel criteria. The Amsel criteria are: 1) Homogenous white discharge, 2) pH > 4.5, 3) amine odor (whiff) test, 4) clue cells on microscopy
Measured: week 22
Number of Subjects Who Experienced Recurrence 30 Weeks After Start of Initial Treatment
Recurrence was measured using the Amsel criteria. The Amsel criteria are: 1) Homogenous white discharge, 2) pH > 4.5, 3) amine odor (whiff) test, 4) clue cells on microscopy
Measured: week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start9 Jul 2021
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Bacterial VaginosisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Lupin Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Chemen M. Neal, Indiana University
- Investigators
- Chemen Neal, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033743
- Sponsor's protocol ID
- 10283
- Status last verified
- Feb 2024
- First submitted
- 9 Aug 2021
- Last updated
- 5 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study
- ClinicalTrials.gov ID
- NCT05033743
- Acronym / sponsor ID
- 10283
- Conditions
- Recurrent Bacterial Vaginosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Lupin Pharmaceuticals, Inc.
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Posted 5 Feb 2024
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 test the effectiveness Secnidazole to treat recurrent BV. Secnidazole is approved for one-time use in acute BV. In this study, the drug will be used for recurrent BV, and given weekly for 18 weeks.
Detailed description
A single-center prospective pilot study with once-weekly oral secnidazole granule treatment of acute condition for two-weeks followed by prophylactic treatment of asymptomatic responders with once-weekly secnidazole for 16 weeks, followed by no therapy for 12 weeks. The final follow-up evaluation is at week 28.
Eligible women with a current symptomatic bacterial vaginosis infection (> or = 3 Amsel criteria) and a history of at least 2 previous episodes of bacterial vaginosis in the past year will be enrolled in the open-label treatment study. All women will be treated with 2g of secnidazole granules orally once-weekly for 2 weeks. At the second visit, 3-5 days after completion of treatment, women who have a resolution of bacterial vaginosis (asymptomatic and < or = 2 Amsel criteria) will continue on once-weekly secnidazole for 16 weeks.
Patients will be evaluated every 4 weeks for recurrence of bacterial vaginosis. This will include questions about symptoms as well as a pelvic examination for assessment of vaginal discharge (> or = 3 Amsel criteria). We will also collect any information on other clinical evaluations for recurrence and the dates of diagnoses and types of treatments they may have received. Those who remain without recurrence during the 16-week suppressive phase will be followed for an additional 12 weeks off therapy, with assessment for recurrence at weeks 22 and 30. Throughout the study, data will be collected on participants' compliance and on the occurrence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Secnidazole 2 GM Oral GranulesSecnidazole treatment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ability to consent in English
- Current symptomatic bacterial vaginosis infection
- History of at least 2 previous episodes of bacterial vaginosis in the past year
Key exclusion criteria (6 listed)
- Current gynecologic infection or condition, including candida vaginitis, gonorrhea, chlamydia, trichomonas, desquamative inflammatory vaginitis, atrophic vaginitis.
- Pre-existing heart conditions
- Pre-existing neurological conditions
- Currently Pregnant or breastfeeding
- Women taking anticoagulants, lithium, metoclopramide, or disulfiram therapy
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 |
|---|---|---|
| Secnidazole 2 GM Oral GranulesOnce weekly 2g oral secnidazole for 18 weeks | Drug | Treatment Group |
Primary outcome
Number of Subjects With at Least One Episode of Bacterial Vaginosis
Time frame: 30 weeks
Overall failure rate as measured by the number of subjects with at least one episode of bacterial vaginosis in the 30 week follow-up period.
Probability of Failure at 210 Days
Time frame: 210 days (30 weeks)
To assess the efficacy of secnidazole, we estimated failure rates and 95% exact confidence intervals for initial treatment, suppression therapy following initial resolution of BV symptoms, and overall. For the time-to-failure analysis, time was defined as the number of days since the second visit where clinical resolution of initial BV was confirmed. The non-parametric maximum likelihood estimate (NPMLE) of the survival curve was estimated using the interval package in R to account for the interval censored data. Results are presented using an Amsel criteria score of as well as for BV diagnosis. All analyses were conducted using R 4.2.2 (R Core Team, 2020) in RStudio (RStudio Team 2021).
The Number of Subjects That Failed Treatment in the Supressive Phase
Time frame: 30 weeks
The probability of recurrence or treatment failure was calculated as time from the second visit in days. This timeframe is the suppressive therapy phase and was 30 weeks long.
7 secondary outcomes
Number of Subjects Who Experienced Recurrence 3-5 Days After Initial Treatment (Initial Treatment Was 2 Weeks Long)
Time frame: 3-5 days after initial treatment after initial treatment of 2 weeks
Number of Subjects Who Experienced Recurrence 6 Weeks After Start of Initial Treatment
Time frame: week 6
Number of Subjects Who Experienced Recurrence 10 Weeks After Start of Initial Treatment
Time frame: week 10
Number of Subjects Who Experienced Recurrence 14 Weeks After Start of Initial Treatment
Time frame: week 14
Number of Subjects Who Experienced Recurrence 18 Weeks After Start of Initial Treatment
Time frame: week 18
Number of Subjects Who Experienced Recurrence 22 Weeks After Start of Initial Treatment
Time frame: week 22
Number of Subjects Who Experienced Recurrence 30 Weeks After Start of Initial Treatment
Time frame: week 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Recurrent Bacterial Vaginosis
Active, not recruitingPhase 1/2
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Photobiomodulation With Blue LED in Recurrent Bacterial Vaginosis
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Recruiting
The Genital Microbiome of Male Partners of Women With Recurrent BV Undergoing Vaginal Microbiome Transplantation
Bacterial Vaginosis, Microbial Colonization
RecruitingPhase 1/2
Vaginal Microbiota Transplant
Recurrent Bacterial Vaginosis
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Evaluation of the Ability of Lactobacillus Crispatus CRP21 to Reduce the Incidence of Recurrent Bacterial Vaginosis
Recurrent Bacterial Vaginosis
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.
Chemen Neal, MD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Secnidazole 2 GM Oral Granules in people with Recurrent Bacterial Vaginosis, run by Indiana University at 1 site in United States.
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 3 inclusion and 6 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 5 Feb 2024. 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 United States. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 5 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With at Least One Episode of Bacterial Vaginosis (time frame: 30 weeks). The study lists 3 primary outcomes in all. 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 5 Feb 2024.