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CompletedNCT05033743Updated Feb 5, 2024Results posted

Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study

A Phase 2/3 interventional study of Secnidazole 2 GM Oral Granules in Recurrent Bacterial Vaginosis, sponsored by Indiana University. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-02-05.

Sponsored by Indiana University · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Recurrent Bacterial Vaginosis
03

In context

Vaginosis, Bacterial

220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.

This study's enrollment of 24 is below the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.

Browse Vaginosis, Bacterial studies →

Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Ability to consent in English
  • Current symptomatic bacterial vaginosis infection
  • History of at least 2 previous episodes of bacterial vaginosis in the past year

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Treatment Group

    Secnidazole treatment

    Drug: Secnidazole 2 GM Oral Granules

Interventions

  • DrugSecnidazole 2 GM Oral Granules

    Once weekly 2g oral secnidazole for 18 weeks

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 weeks

  2. 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).

    Time frame: 210 days (30 weeks)

  3. 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.

    Time frame: 30 weeks

Secondary outcomes

  1. 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

    Time frame: 3-5 days after initial treatment after initial treatment of 2 weeks

  2. 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

    Time frame: week 6

  3. 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

    Time frame: week 10

  4. 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

    Time frame: week 14

  5. 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

    Time frame: week 18

  6. 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

    Time frame: week 22

  7. 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

    Time frame: week 30

Other outcomes

  1. 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.

    Time frame: 18 weeks

  2. 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.

    Time frame: 18 weeks

  3. Number of Adverse Events

    Number of adverse events that participants experienced

    Time frame: 30 weeks

07

Results

Posted Feb 5, 2024

Participant flow

Participant flow — Overall Study
MilestoneTreatment Group
Started24
Completed20
Not completed4
Withdrew: Lost to follow-up1
Withdrew: Protocol violation2
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryNumber 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.

Time frame:
30 weeks
Reported as:
Count of participants · Participants
Number of Subjects With at Least One Episode of Bacterial Vaginosis
ParticipantsTreatment Group
Number of Subjects With at Least One Episode of Bacterial Vaginosis8
PrimaryProbability 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).

Time frame:
210 days (30 weeks)
Reported as:
Number · Probability
Probability of Failure at 210 Days
ProbabilityTreatment Group
Probability of Failure at 210 Days0.7051
PrimaryThe 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.

Time frame:
30 weeks
Reported as:
Count of participants · Participants
The Number of Subjects That Failed Treatment in the Supressive Phase
ParticipantsTreatment Group
The Number of Subjects That Failed Treatment in the Supressive Phase3
SecondaryNumber 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

Time frame:
3-5 days after initial treatment after initial treatment of 2 weeks
Reported as:
Count of participants · Participants
Number of Subjects Who Experienced Recurrence 3-5 Days After Initial Treatment (Initial Treatment Was 2 Weeks Long)
ParticipantsTreatment Group
Number of Subjects Who Experienced Recurrence 3-5 Days After Initial Treatment (Initial Treatment Was 2 Weeks Long)5
SecondaryNumber 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

Time frame:
week 6
Reported as:
Count of participants · Participants
Number of Subjects Who Experienced Recurrence 6 Weeks After Start of Initial Treatment
ParticipantsTreatment Group
Number of Subjects Who Experienced Recurrence 6 Weeks After Start of Initial Treatment0
SecondaryNumber 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

Time frame:
week 10
Reported as:
Count of participants · Participants
Number of Subjects Who Experienced Recurrence 10 Weeks After Start of Initial Treatment
ParticipantsTreatment Group
Number of Subjects Who Experienced Recurrence 10 Weeks After Start of Initial Treatment0
SecondaryNumber 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

Time frame:
week 14
Reported as:
Count of participants · Participants
Number of Subjects Who Experienced Recurrence 14 Weeks After Start of Initial Treatment
ParticipantsTreatment Group
Number of Subjects Who Experienced Recurrence 14 Weeks After Start of Initial Treatment1
SecondaryNumber 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

Time frame:
week 18
Reported as:
Count of participants · Participants
Number of Subjects Who Experienced Recurrence 18 Weeks After Start of Initial Treatment
ParticipantsTreatment Group
Number of Subjects Who Experienced Recurrence 18 Weeks After Start of Initial Treatment1
SecondaryNumber 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

Time frame:
week 22
Reported as:
Count of participants · Participants
Number of Subjects Who Experienced Recurrence 22 Weeks After Start of Initial Treatment
ParticipantsTreatment Group
Number of Subjects Who Experienced Recurrence 22 Weeks After Start of Initial Treatment2
SecondaryNumber 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

Time frame:
week 30
Reported as:
Count of participants · Participants
Number of Subjects Who Experienced Recurrence 30 Weeks After Start of Initial Treatment
ParticipantsTreatment Group
Number of Subjects Who Experienced Recurrence 30 Weeks After Start of Initial Treatment3
Other pre-specifiedNumber 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.

Time frame:
18 weeks
Reported as:
Count of participants · Participants
Number of Participant With Compliance
ParticipantsTreatment Group
Number of Participant With Compliance15
Other pre-specifiedNumber 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.

Time frame:
18 weeks
Reported as:
Count of participants · Participants
Number of Participants With Tolerance
ParticipantsTreatment Group
Number of Participants With Tolerance24
Other pre-specifiedNumber of Adverse Events

Number of adverse events that participants experienced

Time frame:
30 weeks
Reported as:
Number · adverse events
Number of Adverse Events
adverse eventsTreatment Group
Number of Adverse Events41

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment Group0/24 (0%)0/24 (0%)10/24 (41.7%)
Most frequent other events
Showing 10 of 11
Most frequent other events
EventTreatment Group
Yeast InfectionSkin and subcutaneous tissue disorders7/24
HeadacheNervous system disorders2/24
Loose StoolGastrointestinal disorders2/24
UTIRenal and urinary disorders2/24
NauseaGastrointestinal disorders1/24
left lower quadrent painGastrointestinal disorders1/24
spottingReproductive system and breast disorders1/24
urinary odorRenal and urinary disorders1/24
change in dischargeReproductive system and breast disorders1/24
COVID-19 infectionInfections and infestations1/24

Baseline characteristics

prescribed once-weekly secnidazole for 16 weeks as prophylactic treatment

Age, Categorical
Age, Categorical(Participants)Secnidazole
<=18 years0
Between 18 and 65 years24
>=65 years0
Age, Continuous
Age, Continuous(years)Secnidazole
Mean35.3 ± 9.8
Sex: Female, Male
Sex: Female, Male(Participants)Secnidazole
Female24
Male0
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Secnidazole
Black16
Hispanic1
White7
Region of Enrollment
Region of Enrollment(participants)Secnidazole
United States24
Bacterial Vaginosis (BV) episodes in prior 12 months
Bacterial Vaginosis (BV) episodes in prior 12 months(episodes)Secnidazole
Mean8.1 ± 6.4
08

Study locations

1 site
  • Indiana University Hospital - Coleman Center for Women
    Indianapolis, Indiana 46202, United States
09

References and documents

Study documents

  • Study protocol · Jun 1, 2021
  • Statistical analysis plan · Feb 17, 2023
  • Informed consent form · Aug 17, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05033743
Lead sponsor
Indiana University
Collaborators
Lupin Pharmaceuticals, Inc.
Responsible party
Chemen M. Neal (Assistant Clinical Professor, Indiana University) — Principal investigator
First posted
Sep 5, 2021
Start date
Jul 9, 2021
Primary completion
Oct 7, 2022
Completion
Oct 7, 2022
Results posted
Feb 5, 2024
Last update
Feb 5, 2024

Study contacts

Chemen Neal, MD
principal investigator · Assistant Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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