CompletedPhase 2

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

United States100 participantsStarted 2009-03

Plain-language summary

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

Age range40 Years – 75 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Percent Change in Frequency of Hot Flashes Over Time

Timeframe: Week 4 minus baseline week

Percent Change in Composite Score Over Time

Timeframe: Week 4 minus baseline week

NCT IDNCT00875420

SponsorRadius Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-01

Results submitted2011-02-16