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Sponsored by: |
Radius Health |
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Information provided by: | Radius Health |
ClinicalTrials.gov Identifier: | NCT00875420 |
The purpose of this study is to determine whether RAD1901 is effective in decreasing hot flashes in postmenopausal women.
Condition | Intervention | Phase |
---|---|---|
Hot Flashes Vasomotor Symptoms |
Drug: RAD1901 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 2, Multi-Center, Dose-Finding Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women |
Estimated Enrollment: | 100 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
RAD1901
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Drug: RAD1901
Oral Once a day
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Placebo: Placebo Comparator
None
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Drug: Placebo
Oral
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Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Clinical Operations | 617-551-4700 | info@radiuspharm.com |
United States, Massachusetts | |
Radius Health | Recruiting |
Cambridge, Massachusetts, United States, 02139 |
Study Director: | Medical Director | Radius Health, Inc. |
Responsible Party: | Radius Health, Inc. ( Program Director ) |
Study ID Numbers: | RAD1901-002 |
Study First Received: | March 6, 2009 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00875420 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
hot flashes hot flushes vasomotor symptoms postmenopausal |
Signs and Symptoms Hot Flashes Flushing |
Signs and Symptoms Hot Flashes |