A Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women

Completed · Phase 2 · Has a placebo group

Conditions studied: Hot Flashes

In brief

The purpose of this study is to determine whether RAD1901 is effective in decreasing hot flashes in postmenopausal women.

Key facts

Study ID

NCT00875420

Run by

Radius Pharmaceuticals, Inc.

People needed

100

Starts

2009-03-01

Expected to finish

2010-04-01

Last updated by the study team

2018-09-26

Who can join

Age: 40 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Radius Health, Inc. — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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