Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g for the Treatment of Adolescent Girls With BV

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

Study Overview

• Status: Completed
• Conditions: Bacterial Vaginoses
• Intervention / Treatment: Drug: Secnidazole

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Site 1004 - Investigational Research Center
  • Florida
    • Hialeah, Florida, United States, 33016
      • Site 1005 - Investigational Research Center
    • Miami Lakes, Florida, United States, 33161
      • Site 1001 - Investigational Research Center
    • Sarasota, Florida, United States, 34239
      • Site 1010 - Investigational Research Center
    • Tampa, Florida, United States, 33613
      • Site 1013
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Site 1011 - Investigational Research Center
  • Michigan
    • Saginaw, Michigan, United States, 48604
      • Site 1008 - Investigational Research Center
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Site 1007 - Investigational Research Center
  • Texas
    • Frisco, Texas, United States, 75035
      • Site 1006 - Investigational Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Are adolescent girls 12-17 years of age.
2. 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)
3. 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.
4. Willing and able to participate in the study as an outpatient, make required visits to the study center, and comply with all study requirements.
5. 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.

6. Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:

   1. Off-white (milky or gray), thin, homogeneous vaginal discharge AND
   2. Vaginal pH > 4.5 AND
   3. Presence of Clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount AND
   4. A positive 10% KOH Whiff test.
7. Agree to abstain from vaginal intercourse until after the TOC visit.
8. 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.).
9. Agree not to use vaginal douches or similar products for the duration of the study.

Exclusion Criteria:

1. Are pregnant, lactating, or planning to become pregnant during the study.
2. Are menstruating or have vaginal bleeding at the Baseline Visit (Day 1).
3. Are menopausal as determined by the Investigator.
4. 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.
5. 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).
6. Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline Visit (Day 1).
7. Are using NuvaRing® or any other vaginal ring products.
8. Have consumed any alcohol within 12 hours prior to treatment with study medication.
9. Have a history of drug or alcohol abuse within the past 6 months, as determined by the Investigator.
10. 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).
11. Are participating in any investigational, observational or non-interventional study (either currently or during the study).
12. Have had previous exposure to SYM-1219 or participation in other clinical trials of SYM-1219.
13. Have a known allergy to nitroimidazoles (e.g., metronidazole, tinidazole, nimorazole, etc.).
14. Have a history of an abnormal Pap smear which required cervical biopsy or cervical cauterization within 3 months of the Baseline Visit (Day 1).
15. Have any history of cervical carcinoma or other carcinomas of the vagina or vulva.
16. Have any condition that interferes with their ability to understand or comply with the requirements of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single dose Solosec (secnidazole) 2g oral; Solosec 2 grams, oral	Drug: Secnidazole; One dose; Other Names: Solosec™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	At TOC visit study day 7-14
Investigator Clinical Assessment	Investigator's opinion of the need for additional BV treatment. (Yes/No)	At TOC visit study day 7-14
Patient's Continued Clinical Response	Investigator's opinion of the continued clinical response to treatment (Yes/No)	At TOC visit study day 7-14

Collaborators and Investigators

• Sponsor: Lupin Research Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2018
• Primary Completion (Actual): November 5, 2020
• Study Completion (Actual): November 5, 2020

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: May 1, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Adolescents; Vaginal fishy smell; Vaginal itching; off-white milky vaginal discharge
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Secnidazole
• Other Study ID Numbers: SYM-1219-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No