The Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents

Inclusion Criteria:

1. The study population will include pregnant adolescents who reside in the US and meetall of the following criteria for inclusion: The participant is a pregnant femalebetween the following ages: at least 12 years on the day of recruitment (i.e., Day 1)and not yet 18 years on the last day of the study (i.e., Day 15).
2. The participant must provide written informed consent and/or assent to participate inthe study and agrees that she will follow dosing instructions and complete allrequired study visits.
3. The participant's entry ultrasound indicates a viable singleton pregnancy and confirmsgestational age of the fetus is 7-15 weeks + 0 days at the anticipated time of thefirst dose of study drug provided that her NVP symptoms began ≤ 10 weeks gestation. Ifan ultrasound was performed within 4 weeks of the study entry visit, and results canbe obtained, an additional ultrasound is not necessary.
4. The participant is suffering from NVP and has a PUQE score ≥ 6.
5. The participant has not responded to conservative management consisting ofdietary/lifestyle advice according to the 2018 ACOG Practice Bulletin.
6. The participant agrees, if on a multivitamin, to continue on her current dose ofmultivitamin for the duration of the trial.
7. The participant does not plan termination of the pregnancy.
8. The participant is judged to be in good health based on her medical history, physicalexamination and laboratory tests
9. The participant must be able to swallow the study drug whole (i.e., without splitting,crushing, or chewing the tablets) on an empty stomach.

Exclusion Criteria:

1. The investigator confirms the participant's nausea and vomiting is of etiology otherthan NVP.
2. The participant has gestational trophoblastic disease or multifetal gestation.
3. The participant has a condition for which antihistamines, in the opinion of theinvestigator, are contraindicated (e.g., epilepsy, alcoholism, glaucoma, chronic lungdisease, urinary retention, and heart block).
4. The participant has a known hypersensitivity to doxylamine succinate, otherethanolamine derivative antihistamines, pyridoxine hydrochloride, or any inactiveingredient in the Bonjesta or placebo formulation.
5. The participant is taking a monoamine oxidase inhibitor.
6. The participant has used antihistamines, anticholinergics, dopamine antagonists,serotonin antagonists, ginger, recreational drugs including cannabis or anti-emetictherapy (including acupressure, acupuncture, homeopathic remedies, medical hypnosis,and relief bands) to treat NVP in the previous 48 hours or plans to do so during thestudy.
7. The participant is using drugs that have anticholinergic activity (e.g., tricyclicantidepressants).
8. The participant is taking multivitamins containing more than 10 mg of vitamin B6 orplans to do so during the study.
9. The participant is taking supplementary vitamin B6 in addition to any multivitaminpreparation or plans to do so during the study (e.g., total vitamin B6 greater than 10mg).
10. The participant has a medical condition resulting in gastrointestinal malabsorption,such as celiac disease, Crohn's disease, and ulcerative colitis (i.e., may result inlow or deficient levels of vitamin B6).
11. The participant is currently drinking any amount of alcohol or taking illicit drugs
12. The participant has any condition that might interfere with the conduct of the study,in the opinion of the investigator. For example, Bonjesta should be used with cautionin females with asthma, increased intraocular pressure, narrow angle glaucoma,stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neckobstruction.
13. The participant is likely to be unable to comply with study procedures because ofinadequate cognitive or language skills.
14. The participant has received an investigational drug within 30 days before enrollmentin this study or is scheduled to receive an investigational drug during the course ofthis study.
15. The participant is currently breastfeeding.