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Study stopping criteria met with regards to vital sign measurements post dose.
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The purpose of this study is to determine the effective dose or dose range of AR08 in the treatment of VMS in menopausal females.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR08 0.5 mg/day | Experimental | AR08 QD oral dosing for 14 weeks |
|
| AR08 1.0 mg/day | Experimental | AR08 QD oral dosing for 14 weeks |
|
| AR08 2.0 mg/day | Experimental | AR08 QD oral dosing for 14 weeks |
|
| Placebo | Placebo Comparator | Placebo QD oral dosing for 14 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR08 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from Baseline in the frequency and severity of moderate to severe hot flashes | Weeks 4 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression - Improvement (PGI-I) | Weeks 4, 8, and 12 |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis Center for Clinical Research | San Diego | California | 92103 | United States | ||
| Clinical Research Advantage, Inc. |
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| Drug |
|
| Colorado Springs |
| Colorado |
| 80906 |
| United States |
| Blue Skies Center for Women | Colorado Springs | Colorado | 80910 | United States |
| Altus Research | Lakeworth | Florida | 99461 | United States |
| OB-GYN Associates of Mid-Florida, P.A. | Leesburg | Florida | 34748 | United States |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | United States |
| Cypress Medical Research Center | Wichita | Kansas | 67226 | United States |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89123 | United States |
| Lawrence OB/Gyn Associates | Lawrenceville | New Jersey | 08648 | United States |
| Hawthorne Medical Research, Inc. | Winston-Salem | North Carolina | 27103 | United States |
| Clinical Research of Philadelphia, LLC | Philadelphia | Pennsylvania | 19114 | United States |
| Chattanooga Medical Research, LLC | Chattanooga | Tennessee | 37404 | United States |
| TMC Life Research, Inc. | Houston | Texas | 77054 | United States |
| Tidewater Physicians for Women | Norfolk | Virginia | 23502 | United States |
| Seattle Womens: Health, Research, Gynecology | Seattle | Washington | 98105 | United States |