Safety and Efficacy Study of AR08 for the Treatment of Vasomotor Symptoms (VMS)
NCT ID: NCT02049164
Last Updated: 2015-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
32 participants
INTERVENTIONAL
2014-01-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AR08 0.5 mg/day
AR08 QD oral dosing for 14 weeks
AR08
AR08 1.0 mg/day
AR08 QD oral dosing for 14 weeks
AR08
AR08 2.0 mg/day
AR08 QD oral dosing for 14 weeks
AR08
Placebo
Placebo QD oral dosing for 14 weeks
Placebo
Interventions
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AR08
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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
41 Years
FEMALE
No
Sponsors
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Arbor Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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AR08.100
Identifier Type: -
Identifier Source: org_study_id