Design of OASIS 1 and 2: phase 3 clinical trials assessing the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause.

Objective: Elinzanetant is a selective neurokinin-1,3 receptor antagonist in development for the treatment of vasomotor symptoms (VMS) associated with menopause. The pivotal, double-blind, randomized, placebo-controlled phase 3 studies Overall Assessment of efficacy and Safety of elinzanetant In patients with vasomotor Symptoms (OASIS) 1 and 2 will assess the efficacy and safety of elinzanetant in women with VMS.

Methods: The OASIS 1 and 2 pivotal studies are designed in accordance with regulatory guidance.

The burden of illness of severe nausea and vomiting of pregnancy in the United States.

Objective: Our purpose was to determine the extent to which nausea and vomiting of pregnancy affects a woman's quality of life (QOL), ability to function, and health care resource use.

Study Design: We conducted an observational, multicenter, prospective cohort study by gathering data on the symptoms, QOL, and health care resource use from women who have nausea and vomiting of pregnancy.

Results: All 8 domains of health measured by the Short Form-36 QOL survey were limited by patient symptoms.

Nausea and vomiting of pregnancy. Evidence-based treatment algorithm.

Question: One of my patients suffers from a moderate-to-severe form of morning sickness. She responded only partially to doxylamine and pyridoxine (Dicletin), and I wish to try adding another medication. What should my priority be?

Answer: An algorithm used by Motherisk to manage thousands of patients takes a hierarchical approach to this condition.

The safety of higher than standard dose of doxylamine-pyridoxine (Diclectin) for nausea and vomiting of pregnancy.

A delayed-release combination of doxylamine-pyridoxine (D-P) (Diclectin) is the only approved antiemetic medication for use in pregnancy in Canada. The standard recommended dose is up to 4 tablets a day, regardless of body weight or severity of symptoms. The objective of this study was to determine the incidence of adverse maternal and fetal effects and pregnancy outcome in 225 women taking Diclectin at the recommended (n = 123) or higher than recommended (n = 102) doses.

Determinants of the need for hospital care among women with nausea and vomiting of pregnancy.

Objectives: To characterize a cohort of pregnant women who required hospital care owing to nausea and vomiting of pregnancy (NVP) and to identify variables that could serve as predictors of the need for hospital care.

Design: A retrospective, observational study.

Methods: Between 1996 and 1997, women who suffered from NVP were invited to call the NVP Healthline at The Motherisk Program in Toronto.