Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Arbor Pharmaceuticals, Inc.
Age
41–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Safety and Efficacy Study of AR08 for the Treatment of Vasomotor Symptoms (VMS)
