A Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women
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ClinicalTrials.gov Identifier: NCT00875420 |
Recruitment Status :
Completed
First Posted : April 3, 2009
Results First Posted : March 26, 2012
Last Update Posted : September 26, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hot Flashes | Drug: RAD1901 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | April 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: RAD1901 10 mg
Oral once a day for 28 days
|
Drug: RAD1901
10 mg Oral once a day for 28 days. |
Experimental: RAD1901 25 mg
Oral once a day for 28 days
|
Drug: RAD1901
25 mg Oral once a day for 28 days |
Experimental: RAD1901 50 mg
Oral once a day for 28 days
|
Drug: RAD1901
50 mg Oral once a day for 28 days. |
Experimental: RAD1901 100 mg
Oral once a day for 28 days
|
Drug: RAD1901
100 mg Oral once a day for 28 days |
Placebo Comparator: Placebo
Oral once a day for 28 days
|
Drug: Placebo
Placebo Oral once a day for 28 days |
- Percent Change in Frequency of Hot Flashes Over Time [ Time Frame: Week 4 minus baseline week ]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.
- Percent Change in Composite Score Over Time [ Time Frame: Week 4 minus baseline week ]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.
- Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time. [ Time Frame: Day 29 minus baseline ]Percent change in FSH at Day 29 compared to baseline, in the intent-to-treat population.
- Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time. [ Time Frame: Day 29 minus baseline ]Percent change in LH levels at Day 29 compared to baseline, in the intent-to-treat population.

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Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875420
United States, Massachusetts | |
Radius Health, Inc. | |
Cambridge, Massachusetts, United States, 02139 |
Study Director: | Medical Director | Radius Health, Inc. |
Responsible Party: | Radius Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00875420 |
Other Study ID Numbers: |
RAD1901-002 |
First Posted: | April 3, 2009 Key Record Dates |
Results First Posted: | March 26, 2012 |
Last Update Posted: | September 26, 2018 |
Last Verified: | August 2018 |
hot flashes hot flushes vasomotor symptoms postmenopausal |
Hot Flashes |