Bacterial VaginosesPhase 4NCT03937869
Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g for the Treatment of Adolescent Girls With BV
A Phase 4 study testing Secnidazole in people with Bacterial Vaginoses, run by Lupin Research Inc at 9 sites in United States.
Trial summary
A multi-center, open-label study to evaluate the treatment of one oral dose of 2g Solosec™ (Secnidazole) in adolescent girls with BV Read more about this study
- Who is it for?
- Ages 12 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginoses
- What is being tested?
- Secnidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 9 sitesUnited States
- Study dates
- 28 Nov 2018to 5 Nov 2020
- 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 12 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Are adolescent girls 12-17 years of age.
- Are willing and able to give written informed assent with a written informed consent from a parent or legal guardian. (Amendment 01- Assent only if State allowed)
- Are in good general health including as confirmed by a medical history and physical examination, with no known medical or mental health conditions that, in the Investigator's opinion, may interfere with study participation.
- Willing and able to participate in the study as an outpatient, make required visits to the study center, and comply with all study requirements.
- Have a negative urine pregnancy test result prior to study treatment initiation. In addition, female patients of childbearing potential must be using an acceptable form of birth control as determined by the Investigator (e.g., oral contraception, implantable, injectable or transdermal hormonal contraception, intrauterine device [IUD], double-barrier methods, have a vasectomized partner or abstinence [if the patient becomes sexually active they must use one of the acceptable methods of birth control]). Note: NuvaRing® or any other vaginal ring products are not permitted.
- Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:
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- Off-white (milky or gray), thin, homogeneous vaginal discharge AND
- Vaginal pH > 4.5 AND
- Presence of Clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount AND
- A positive 10% KOH Whiff test.
- Agree to abstain from vaginal intercourse until after the TOC visit.
- Agree not to have any vaginal penetration or use of any vaginal products until after the TOC visit (e.g., spermicides, condoms, diaphragms, vibrators, tampons, etc.).
- Agree not to use vaginal douches or similar products for the duration of the study.
Who cannot join
- Are pregnant, lactating, or planning to become pregnant during the study.
- Are menstruating or have vaginal bleeding at the Baseline Visit (Day 1).
- Are menopausal as determined by the Investigator.
- Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex or human papilloma virus.
- Have active genital lesions, including active Herpes simplex lesions, or other vaginal or vulvar conditions which could confound the interpretation of the clinical response, as determined by the Investigator (patients with genital warts that are not being treated may be enrolled).
- Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline Visit (Day 1).
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- Are using NuvaRing® or any other vaginal ring products.
- Have consumed any alcohol within 12 hours prior to treatment with study medication.
- Have a history of drug or alcohol abuse within the past 6 months, as determined by the Investigator.
- Have participated in any investigational trial within 30 days or six half-lives of the test drug's biologic activity, whichever is longer, before the Baseline Visit (Day 1).
- Are participating in any investigational, observational or non-interventional study (either currently or during the study).
- Have had previous exposure to SYM-1219 or participation in other clinical trials of SYM-1219.
- Have a known allergy to nitroimidazoles (e.g., metronidazole, tinidazole, nimorazole, etc.).
- Have a history of an abnormal Pap smear which required cervical biopsy or cervical cauterization within 3 months of the Baseline Visit (Day 1).
- Have any history of cervical carcinoma or other carcinomas of the vagina or vulva.
- Have any condition that interferes with their ability to understand or comply with the requirements of the study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Site 1011 - Investigational Research Center
Bardstown, Kentucky, 40004
Site 1006 - Investigational Research Center
Frisco, Texas, 75035
Site 1005 - Investigational Research Center
Hialeah, Florida, 33016
Site 1004 - Investigational Research Center
Long Beach, California, 90806
Site 1007 - Investigational Research Center
Memphis, Tennessee, 38104
Site 1001 - Investigational Research Center
Miami Lakes, Florida, 33161
Site 1008 - Investigational Research Center
Saginaw, Michigan, 48604
Site 1010 - Investigational Research Center
Sarasota, Florida, 34239
Site 1013
Tampa, Florida, 33613
About this study
Official title: A Multi-Center, Open-Label Study to Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g Oral Granules for the Treatment of Adolescent Girls With Bacterial Vaginosis
A multi-center, open-label study to evaluate the treatment of one oral dose of 2g Solosec™ (Secnidazole) in adolescent girls with BV
Read the detailed description
This is a multi-center, open-label study to evaluate the safety of Solosec in adolescent girls with bacterial vaginosis. Approximately 40 patients will be enrolled. Patients determined to be eligible at the Baseline Visit (Day 1) will receive a single oral dose of Solosec™ granules (containing 2 grams of secnidazole) on Day 1. Patients will return to the site once between Days 7-14 for a "test of cure" (TOC) Visit. A follow-up telephone call will be performed at Days 21-30 to assess the continued clinical response to treatment and adverse events.
- Conditions
- Bacterial Vaginoses
- Being tested
- Secnidazole
- Keywords
- Adolescents, Vaginal fishy smell, Vaginal itching, off-white milky vaginal discharge
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecnidazoleDrug
Also called Solosec™
One dose
| Study group | Role | What they receive |
|---|---|---|
| Single dose Solosec (secnidazole) 2g oral | Other | Solosec 2 grams, oral Receives: Drug: Secnidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome Responder
Defined as patients with resolution of abnormal vaginal , negative 10% KOF WHIFF test, and Clue cells less than 20% of the total epithelial cells
Measured: At TOC visit study day 7-14
Nugent Score
All patients with a score of 0-3 will be considered normal; scores of 4 and above will considered abnormal.
Measured: At TOC visit study day 7-14
Investigator Clinical Assessment
Investigator's opinion of the need for additional BV treatment. (Yes/No)
Measured: At TOC visit study day 7-14
Patient's Continued Clinical Response
Investigator's opinion of the continued clinical response to treatment (Yes/No)
Measured: At TOC visit study day 7-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start28 Nov 2018
- Primary completion5 Nov 2020
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lupin Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937869
- Sponsor's protocol ID
- SYM-1219-401
- Status last verified
- Dec 2020
- First submitted
- 22 Apr 2019
- Last updated
- 19 Dec 2020
- Results posted
- No
- 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 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label Study to Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g Oral Granules for the Treatment of Adolescent Girls With Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT03937869
- Acronym / sponsor ID
- SYM-1219-401
- Conditions
- Bacterial Vaginoses
- Keywords
- Adolescents, Vaginal fishy smell, Vaginal itching, off-white milky vaginal discharge
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lupin Research IncIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 6 May 2019 (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.
A multi-center, open-label study to evaluate the treatment of one oral dose of 2g Solosec™ (Secnidazole) in adolescent girls with BV
Detailed description
This is a multi-center, open-label study to evaluate the safety of Solosec in adolescent girls with bacterial vaginosis. Approximately 40 patients will be enrolled. Patients determined to be eligible at the Baseline Visit (Day 1) will receive a single oral dose of Solosec™ granules (containing 2 grams of secnidazole) on Day 1. Patients will return to the site once between Days 7-14 for a "test of cure" (TOC) Visit. A follow-up telephone call will be performed at Days 21-30 to assess the continued clinical response to treatment and 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 |
|---|---|---|
| Single dose Solosec (secnidazole) 2g oral | Other | Drug: SecnidazoleSolosec 2 grams, oral |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Are adolescent girls 12-17 years of age.
- Are willing and able to give written informed assent with a written informed consent from a parent or legal guardian. (Amendment 01- Assent only if State allowed)
- Are in good general health including as confirmed by a medical history and physical examination, with no known medical or mental health conditions that, in the Investigator's opinion, may interfere with study participation.
- Willing and able to participate in the study as an outpatient, make required visits to the study center, and comply with all study requirements.
- Have a negative urine pregnancy test result prior to study treatment initiation. In addition, female patients of childbearing potential must be using an acceptable form of birth control as determined by the Investigator (e.g., oral contraception, implantable, injectable or transdermal hormonal contraception, intrauterine device [IUD], double-barrier methods, have a vasectomized partner or abstinence [if the patient becomes sexually active they must use one of the acceptable methods of birth control]). Note: NuvaRing® or any other vaginal ring products are not permitted.
Key exclusion criteria (16 listed)
- Are pregnant, lactating, or planning to become pregnant during the study.
- Are menstruating or have vaginal bleeding at the Baseline Visit (Day 1).
- Are menopausal as determined by the Investigator.
- Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex or human papilloma virus.
- Have active genital lesions, including active Herpes simplex lesions, or other vaginal or vulvar conditions which could confound the interpretation of the clinical response, as determined by the Investigator (patients with genital warts that are not being treated may be enrolled).
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 |
|---|---|---|
| SecnidazoleAlso: Solosec™One dose | Drug | Single dose Solosec (secnidazole) 2g oral |
Primary outcome
Clinical Outcome Responder
Time frame: At TOC visit study day 7-14
Defined as patients with resolution of abnormal vaginal , negative 10% KOF WHIFF test, and Clue cells less than 20% of the total epithelial cells
Nugent Score
Time frame: At TOC visit study day 7-14
All patients with a score of 0-3 will be considered normal; scores of 4 and above will considered abnormal.
Investigator Clinical Assessment
Time frame: At TOC visit study day 7-14
Investigator's opinion of the need for additional BV treatment. (Yes/No)
Patient's Continued Clinical Response
Time frame: At TOC visit study day 7-14
Investigator's opinion of the continued clinical response to treatment (Yes/No)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Bacterial Vaginoses
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Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 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 Secnidazole in people with Bacterial Vaginoses, run by Lupin Research Inc at 9 sites 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 13 inclusion and 16 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Outcome Responder (time frame: At TOC visit study day 7-14). The study lists 4 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 19 Dec 2020.