Safety and Efficacy Study of AR08 for the Treatment of Vasomotor Symptoms (VMS)
- Registration Number
- NCT02049164
- Lead Sponsor
- Arbor Pharmaceuticals, Inc.
- Brief Summary
The purpose of this study is to determine the effective dose or dose range of AR08 in the treatment of VMS in menopausal females.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 32
-
Generally healthy female > 40 years of age with a body mass index (BMI) ≤ 40;
-
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);
-
Experience a minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week
- 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;
- Subjects with pre-existing orthostatic hypotension at Screening;
- 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;
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AR08 1.0 mg/day AR08 AR08 QD oral dosing for 14 weeks AR08 2.0 mg/day AR08 AR08 QD oral dosing for 14 weeks AR08 0.5 mg/day AR08 AR08 QD oral dosing for 14 weeks Placebo Placebo Placebo QD oral dosing for 14 weeks
- Primary Outcome Measures
Name Time Method Mean change from Baseline in the frequency and severity of moderate to severe hot flashes Weeks 4 and 12
- Secondary Outcome Measures
Name Time Method Patient Global Impression - Improvement (PGI-I) Weeks 4, 8, and 12
Trial Locations
- Locations (15)
Genesis Center for Clinical Research
🇺🇸San Diego, California, United States
Clinical Research Advantage, Inc.
🇺🇸Colorado Springs, Colorado, United States
Blue Skies Center for Women
🇺🇸Colorado Springs, Colorado, United States
Altus Research
🇺🇸Lakeworth, Florida, United States
OB-GYN Associates of Mid-Florida, P.A.
🇺🇸Leesburg, Florida, United States
Comprehensive Clinical Trials, LLC
🇺🇸West Palm Beach, Florida, United States
Cypress Medical Research Center
🇺🇸Wichita, Kansas, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Lawrence OB/Gyn Associates
🇺🇸Lawrenceville, New Jersey, United States
Hawthorne Medical Research, Inc.
🇺🇸Winston-Salem, North Carolina, United States
Scroll for more (5 remaining)Genesis Center for Clinical Research🇺🇸San Diego, California, United States