Safety and Efficacy Study of AR08 for the Treatment of Vasomotor Symptoms (VMS)

Inclusion Criteria: 1. Generally healthy female \> 40 years of age with a body mass index (BMI) ≤ 40; 2. Has undergone menopause defined as any of the following: At least 12 months of spontaneous amenorrhea; or At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \> 40 mIU/mL; or At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy); 3. Experience a minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week Exclusion Criteria: 1. Resting systolic blood pressure (SBP) \<110 mmHg, resting diastolic blood pressure (DBP) \<50 mm Hg, or a resting heart rate (HR) \<60 beats per minute while awake; 2. Subjects with pre-existing orthostatic hypotension at Screening; 3. Use of oral estrogen-, progestin-, androgen-, or selective estrogen receptor modifier (SERM) -containing drug products within 8 weeks prior to Screening; use of transdermal hormone products within 8 weeks prior to Screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to Screening; use of intrauterine progestins within 8 weeks prior to Screening; use of progestin implants or estrogen injectables within 3 months prior to Screening; use of estrogen pellet or progestin injectables within 6 months prior to Screening; 4. History of daily usage (at least 28 days/month) of either of the following during the month prior to initiation of Screening: Antihypertensives or Prophylactic antimigraine medications