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Anti-infective Agent

Secnidazole 2 GM Oral Granules for Bacterial Vaginosis

Phase 2 & 3

Waitlist Available

Led By Chemen Neal, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 210 days (30 weeks)

Awards & highlights

Study Summary

This trial tests if the drug Secnidazole, approved to treat acute BV, is effective when given weekly to treat recurrent BV.

Eligible Conditions

Bacterial Vaginosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 210 days (30 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~210 days (30 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 210 days (30 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Subjects With at Least One Episode of Bacterial Vaginosis

Probability of Failure at 210 Days

The Number of Subjects That Failed Treatment in the Supressive Phase

Secondary outcome measures

Number of Subjects Who Experienced Recurrence 10 Weeks After Start of Initial Treatment

Number of Subjects Who Experienced Recurrence 14 Weeks After Start of Initial Treatment

Number of Subjects Who Experienced Recurrence 18 Weeks After Start of Initial Treatment

+4 more

Other outcome measures

Number of Adverse Events

Number of Participant With Compliance

Number of Participants With Tolerance

Side effects data

From 2022 Phase 2 & 3 trial • 24 Patients • NCT05033743

29%

Yeast Infection

Headache

Loose Stool

UTI

Nausea

left lower quadrent pain

spotting

COVID-19 infection

Post Operative Pulmonary Embolism

urinary odor

change in discharge

100%

80%

60%

40%

20%

Study treatment Arm

Treatment Group

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

Secnidazole treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Secnidazole 2 GM Oral Granules

2021

Completed Phase 3

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Lupin Pharmaceuticals, Inc.Industry Sponsor

1 Previous Clinical Trials

24,258 Total Patients Enrolled

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,137 Total Patients Enrolled

Chemen Neal, MDPrincipal InvestigatorAssistant Professor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary conditions that Secnidazole 2 GM Oral Granules have been shown to improve?

"The oral granules of Secnidazole 2 GM can be used to treat vaginosis caused by bacteria, trichomoniasis, and trichomonas vaginitis."

Answered by AI

Are the elderly able to partake in this research?

"The age range for this study is 18 to 50. However, if you are outside of this age bracket, don't worry! There are 169 other trials for patients that are under 18 and 943 for patients that are over 65."

Answered by AI

Is Secnidazole 2 GM Oral Granules a new medication?

"There is currently one Secnidazole 2 GM Oral Granules clinical trial underway and it is in Phase 3. Although the majority of research trials for Secnidazole 2 GM Oral Granules are conducted in Indianapolis, Indiana, there is at least one other location where the Granules are being studied."

Answered by AI

Have similar investigations been conducted previously?

"Currently, the only ongoing clinical trial for Secnidazole 2 GM Oral Granules is being conducted in one city across one country. This particular trial began in 2021 and is projected to finish in 2023. So far, 8 studies have been completed as part of this Phase 2 & 3 drug approval process."

Answered by AI

Can people still sign up to participate in this experiment?

"The most recent information on clinicaltrials.gov suggests that this trial is still searching for patients. The clinical trial was originally posted on 7/9/2021 and was last updated on 3/22/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Chemen M. Neal 2021. "Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05033743.