Status:
COMPLETED
A Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women
Lead Sponsor:
Radius Pharmaceuticals, Inc.
Conditions:
Hot Flashes
Eligibility:
FEMALE
40-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether RAD1901 is effective in decreasing hot flashes in postmenopausal women.
Eligibility Criteria
Inclusion
- Have documented evidence of a minimum of 7 moderate to severe hot flashes per day, or 50 per week.
- Be in good general health as determined by medical history, physical examination, and inclusion procedures and is without evidence of any clinically significant abnormalities.
- Have a normal pelvic assessment with no clinically significant signs on examination and pelvic ultrasound.
- Have a normal mammogram at the time of study screening.
Exclusion
- A history of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic, immunologic or metabolic diseases to a degree that would compromise patient safety or interfere with the interpretation of study data. A history of active presence of thrombophlebitis, thrombosis, thromboembolic disorders.
- A history of active presence of stroke, transient ischemic attack (TIA), heart attack or ischemic heart disease.
- Unexplained vaginal bleeding within the 3 months prior to study entry.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00875420
Start Date
March 1 2009
End Date
April 1 2010
Last Update
September 26 2018
Active Locations (1)
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1
Radius Health, Inc.
Cambridge, Massachusetts, United States, 02139