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.