A Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women
Status: | Completed |
---|---|
Conditions: | Hot Flash |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 40 - 75 |
Updated: | 9/28/2018 |
Start Date: | March 2009 |
End Date: | April 2010 |
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
The purpose of this study is to determine whether RAD1901 is effective in decreasing hot
flashes in postmenopausal women.
flashes in postmenopausal women.
Inclusion Criteria:
1. Have documented evidence of a minimum of 7 moderate to severe hot flashes per day, or
50 per week.
2. Be in good general health as determined by medical history, physical examination, and
inclusion procedures and is without evidence of any clinically significant
abnormalities.
3. Have a normal pelvic assessment with no clinically significant signs on examination
and pelvic ultrasound.
4. Have a normal mammogram at the time of study screening.
Exclusion Criteria:
1. 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.
2. A history of active presence of stroke, transient ischemic attack (TIA), heart attack
or ischemic heart disease.
3. Unexplained vaginal bleeding within the 3 months prior to study entry.
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