Phase 2
N=100
A Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women
Hot Flashes
Bottom Line
View on ClinicalTrials.gov: NCT00875420 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Percent Change in Frequency of Hot Flashes Over Time — -77.2; -51.8; -53.8; -67.0 Percent change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RAD1901 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Radius Pharmaceuticals, Inc.
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Frequency of Hot Flashes Over Time |
-77.2; -51.8; -53.8; -67.0; -54.1 | — |
| PRIMARY Percent Change in Composite Score Over Time |
-75.65; -55.48; -48.78; -66.21; -55.80 | — |
| SECONDARY Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time. |
4.24; -6.56; -4.42; -3.26; 8.67 | — |
| SECONDARY Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time. |
-12.81; -0.19; -10.94; 3.57; 6.70 | — |
Summary
The purpose of this study is to determine whether RAD1901 is effective in decreasing hot flashes in postmenopausal women.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00875420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.