At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 100 enrolled
Drug / intervention
RAD1901 +4 moredrug
Likely dose
RAD1901 10–100 mg orally once daily for 28 days (dose-finding study with doses of 10, 25, 50, and 100 mg)AI-extracted
Key inclusion· 4
- ✓Minimum 7 moderate to severe hot flashes per day, or 50 per week
- ✓Good general health without clinically significant abnormalities
- ✓Normal pelvic assessment and pelvic ultrasound
- ✓Normal mammogram at screening
Key exclusion· 4
- ✕History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, CNS, hematologic, immunologic or metabolic diseases that would compromise safety or data interpretation
- ✕History of thrombophlebitis, thrombosis, or thromboembolic disorders
- ✕History of stroke, TIA, heart attack, or ischemic heart disease
- ✕Unexplained vaginal bleeding within 3 months prior to study entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating RAD1901 and Placebo for Hot Flashes. Completed, enrolled 100 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether RAD1901 is effective in decreasing hot flashes in postmenopausal women.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHot Flashes
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedApr 2009
Primary CompletionJan 2010
Study CompletionApr 2010
TodayJul 2026
First PostedApr 3, 2009
Enrollment StartMar 1, 2009
Primary CompletionJan 1, 2010
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.2 years ago
Interventions
RAD1901drug
10 mg Oral once a day for 28 days.
RAD1901drug
25 mg Oral once a day for 28 days
RAD1901drug
50 mg Oral once a day for 28 days.
RAD1901drug
100 mg Oral once a day for 28 days
Placebodrug
Placebo Oral once a day for 28 days