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

Phase 2

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

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

Locations (15): Lawrence OB/Gyn Associates
🇺🇸
Lawrenceville, New Jersey, United States
OB-GYN Associates of Mid-Florida, P.A.
🇺🇸
Leesburg, Florida, United States
Tidewater Physicians for Women
🇺🇸
Norfolk, Virginia, United States
Hawthorne Medical Research, Inc.
🇺🇸
Winston-Salem, North Carolina, United States
Cypress Medical Research Center
🇺🇸
Wichita, Kansas, United States
Clinical Research Advantage, Inc.
🇺🇸
Colorado Springs, Colorado, United States
Genesis Center for Clinical Research
🇺🇸
San Diego, California, United States
Comprehensive Clinical Trials, LLC
🇺🇸
West Palm Beach, Florida, United States
Clinical Research Center of Nevada
🇺🇸
Las Vegas, Nevada, United States
Clinical Research of Philadelphia, LLC
🇺🇸
Philadelphia, Pennsylvania, United States
Chattanooga Medical Research, LLC
🇺🇸
Chattanooga, Tennessee, United States
TMC Life Research, Inc.
🇺🇸
Houston, Texas, United States
Altus Research
🇺🇸
Lakeworth, Florida, United States
Seattle Womens: Health, Research, Gynecology
🇺🇸
Seattle, Washington, United States
Blue Skies Center for Women
🇺🇸
Colorado Springs, Colorado, United States