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| Name | Class |
|---|---|
| Lupin Pharmaceuticals, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Secnidazole treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secnidazole 2 GM Oral Granules | Drug | Once weekly 2g oral secnidazole for 18 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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. | 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3-5 days after initial treatment after initial treatment of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participant With Compliance | Subject compliance with the study medication, based on questionnaire that asked if the participant took the medication as scheduled and asked about side effects. | 18 weeks |
| Number of Participants With Tolerance |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chemen Neal, MD | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Hospital - Coleman Center for Women | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
prescribed once-weekly secnidazole for 16 weeks as prophylactic treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Secnidazole | prescribed once-weekly secnidazole for 16 weeks as prophylactic treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 30 weeks |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Yeast Infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chemen M. Neal, Associate Professor | Indiana University School of Medicine | 3172789639 | chmtate@iupui.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2021 | Oct 17, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 17, 2023 | Oct 17, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 17, 2021 | Oct 17, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| 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 | 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 | 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 | 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 | 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 | 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 | week 30 |
Subject tolerance with the study medication, based on questionnaire that asked if the participant took the medication as scheduled and asked about side effects.
| 18 weeks |
| Number of Adverse Events | Number of adverse events that participants experienced | 30 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Bacterial Vaginosis (BV) episodes in prior 12 months | 4 participants were withdrawn or lost to followup before this baseline measure was collected. These participants were excluded from analysis. | Mean | Standard Deviation | episodes |
|
|
| Primary | 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). | The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up. | Posted | Number | Probability | 210 days (30 weeks) |
|
|
|
| Primary | 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. | The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up. | Posted | Count of Participants | Participants | 30 weeks |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 3-5 days after initial treatment after initial treatment of 2 weeks |
|
|
|
| Secondary | 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 | The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up. | Posted | Count of Participants | Participants | week 6 |
|
|
|
| Secondary | 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 | The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up. | Posted | Count of Participants | Participants | week 10 |
|
|
|
| Secondary | 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 | The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up. | Posted | Count of Participants | Participants | week 14 |
|
|
|
| Secondary | 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 | The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up. | Posted | Count of Participants | Participants | week 18 |
|
|
|
| Secondary | 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 | The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up. | Posted | Count of Participants | Participants | week 22 |
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|
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| Secondary | 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 | The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up. | Posted | Count of Participants | Participants | week 30 |
|
|
|
| Other Pre-specified | Number of Participant With Compliance | Subject compliance with the study medication, based on questionnaire that asked if the participant took the medication as scheduled and asked about side effects. | The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up. | Posted | Count of Participants | Participants | 18 weeks |
|
|
|
| Other Pre-specified | Number of Participants With Tolerance | Subject tolerance with the study medication, based on questionnaire that asked if the participant took the medication as scheduled and asked about side effects. | This number of participants includes all subjects, including lost to follow up and withdraws. Only one subject reported intolerance of the medication. | Posted | Count of Participants | Participants | 18 weeks |
|
|
|
| Other Pre-specified | Number of Adverse Events | Number of adverse events that participants experienced | Analysis only includes participants who experienced an AE. | Posted | Number | adverse events | 30 weeks |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 10 |
| 24 |
| Headache | Nervous system disorders | Systematic Assessment |
|
| Loose Stool | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| UTI | Renal and urinary disorders | Systematic Assessment |
|
| left lower quadrent pain | Gastrointestinal disorders | Systematic Assessment |
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| spotting | Reproductive system and breast disorders | Systematic Assessment |
|
| urinary odor | Renal and urinary disorders | Systematic Assessment |
|
| change in discharge | Reproductive system and breast disorders | Systematic Assessment |
|
| COVID-19 infection | Infections and infestations | Systematic Assessment |
|
| Post Operative Pulmonary Embolism | Vascular disorders | Systematic Assessment | One patient suffered a pulmonary embolus while taking oral contraceptives and was in the immediate postoperative state. This was deemed unrelated to the study drug. She did not continue participation in the study due to anticoagulant use. |
|
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| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |