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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Vasomotor Symptoms (VMS)

In brief

The purpose of this study is to determine the effective dose or dose range of AR08 in the treatment of VMS in menopausal females.

Key facts

Study ID

NCT02049164

Run by

Arbor Pharmaceuticals, Inc.

People needed

32

Starts

2014-01-01

Expected to finish

2014-05-01

Last updated by the study team

2015-12-09

Who can join

Age: 41 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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
• Tidewater Physicians for Women — Norfolk, Virginia, United States
• Seattle Womens: Health, Research, Gynecology — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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