A Phase 3, Multi-center, Prospective, Randomized, Placebo-Controlled, Delayed Treatment, Double-Blind Study to Evaluate the Effectiveness and Safety of a Single Oral Dose of Solosec Granules Containing 2 grams of Secnidazole for the Treatment of Trichomoniasis

About this Study

This study will evaluate the efficacy and safety of a single, oral dose of Solosec compared to placebo for the treatment of trichomoniasis. 

Sponsor Protocol ID:SEC-WH-301
IRB Number:2019-0217
Actively Enrolling
Phase 3
November 22, 2019
Eligibility Criteria
12 years old
Both Male and Female

Inclusion CriteriaPatients will be eligible to participate in the study if they meet all of the following criteria: 

1. Are adult females or post-menarchal adolescent girls ≥ 12 years of age. 

2. Are willing and able to give written informed consent or, if

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. Are 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/transdermal hormonal contraception, intrauterine device (IUD), barrier methods), tubal ligation or have a vasectomized partner or are practicing abstinence. 

6. Have a diagnosis of trichomoniasis at the screening visit as determined by one of the following: 
• positive T. vaginalis NAAT test within 30 days of screening for which treatment has not been initiated. 
• positive OSOM® rapid test. 
• positive wet mount assessment. 

7. Agree to abstain from vaginal intercourse until the final study visit. 

8. Agree not to have any vaginal penetration or use of any vaginal products for the duration of the study (e.g., spermicides, condoms, diaphragms, vibrators, tampons, etc.). 

9. Agree not to use vaginal douches, lubricants, or similar products for the duration of the study.

Exclusion CriteriaPatients will be excluded from study participation if they have any of the following criteria: 

1. Are pregnant, lactating, or planning to become pregnant during the study. 

2. Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including symptomatic vulvovaginal candidiasis, chlamydia, gonorrhea, or an active genital herpes outbreak (Note: Chlamydia trachomatis, Neisseria gonorrhoeae [by PCR] results will not be available at time of randomization). Note: patients with bacterial vaginosis (BV) are eligible for this study. 

3. Are suspected clinically of having an acute urinary tract infection. 

4. Have active genital lesions, including primary syphilitic chancres and herpes simplex virus 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 may be enrolled). 

5. Have received systemic antibacterial therapy or topical antimicrobial/antifungal/ immunomodulatory therapies in the genital area (vagina, vulva and surrounding soft tissue), within 14 days prior to the Baseline Visit (Day 1). 

6. Have received secnidazole, metronidazole or tinidazole treatment within 30 days prior to the Baseline Visit (Day 1) or any other medication for the treatment of trichomoniasis within 30 days prior to Baseline Visit. 

7. Are using NuvaRing® or any other vaginal ring products. 

8. Have a history of drug or alcohol abuse within the past 12 months, as determined by the Investigator.

9. Have participated in any investigational trial within 30 days before the Baseline Visit (Day 1). 

10. Are participating in any investigational, observational or non-interventional study (either currently or during the study). 11. Have a known allergy to nitroimidazoles (e.g., metronidazole, tinidazole, nimorazole, secnidazole, etc.). 

12. Inability to consume apple sauce or comply with study medication dosing instructions. 

13. Have any history of cervical carcinoma or other carcinomas of the vagina or vulva or an abnormal Pap smear that may require colposcopic evaluation within the 3 months following the baseline visit (in the opinion of the investigator). 

14. Have undiagnosed abnormal vaginal bleeding. 

15. Are planning to undergo a surgical or vaginal procedure during the study. 

16. Have any condition that interferes with their ability to understand or comply with the requirements of the study.

Categories Click category to view its trials.
Infectious Diseases
Women's Health
Participating Locations
University Hospital
Contact Information
Contact Name: Courtney Sims Gomillia
Phone Number: 601-815-9522
Email: cegomillia@umc.edu
Principal Investigator:Mena, Leandro A, M.D.
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