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

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

Official Title
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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

Conditions
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Hot Flashes

Intervention / Treatment
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* Drug: RAD1901
* Drug: RAD1901
* Drug: RAD1901
* Drug: RAD1901
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAD1901 10 mg<br>Oral once a day for 28 days | Drug: RAD1901<br>* 10 mg Oral once a day for 28 days.<br>|
| Experimental: RAD1901 25 mg<br>Oral once a day for 28 days | Drug: RAD1901<br>* 25 mg Oral once a day for 28 days<br>|
| Experimental: RAD1901 50 mg<br>Oral once a day for 28 days | Drug: RAD1901<br>* 50 mg Oral once a day for 28 days.<br>|
| Experimental: RAD1901 100 mg<br>Oral once a day for 28 days | Drug: RAD1901<br>* 100 mg Oral once a day for 28 days<br>|
| Placebo Comparator: Placebo<br>Oral once a day for 28 days | Drug: Placebo<br>* Placebo Oral once a day for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Frequency of Hot Flashes Over Time | Percent change of moderate and severe hot flash frequency at 4 weeks compared to baseline using weekly Subject diary data, in the intent-to-treat population. | Week 4 minus baseline week | 
| Percent Change in Composite Score Over Time | Percent change in composite score (frequency x severity) of hot flashes (Mild=1, Moderate=2, Severe=3) at 4 weeks compared to baseline, in the intent-to-treat population. | Week 4 minus baseline week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time. | Percent change in FSH at Day 29 compared to baseline, in the intent-to-treat population. | Day 29 minus baseline | 
| Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time. | Percent change in LH levels at Day 29 compared to baseline, in the intent-to-treat population. | Day 29 minus baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hot flashes, hot flushes, vasomotor symptoms, postmenopausal