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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Hot Flashes	Drug: RAD1901; Drug: Placebo	Phase 2

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Have documented evidence of a minimum of 7 moderate to severe hot flashes per day, or 50 per week.
2. Be in good general health as determined by medical history, physical examination, and inclusion procedures and is without evidence of any clinically significant abnormalities.
3. Have a normal pelvic assessment with no clinically significant signs on examination and pelvic ultrasound.
4. Have a normal mammogram at the time of study screening.

Exclusion Criteria:

1. 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.
2. A history of active presence of stroke, transient ischemic attack (TIA), heart attack or ischemic heart disease.
3. Unexplained vaginal bleeding within the 3 months prior to study entry.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Massachusetts
Radius Health, Inc.
Cambridge, Massachusetts, United States, 02139

Sponsors and Collaborators

Radius Health, Inc.

Investigators

Study Director:	Medical Director	Radius Health, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Radius Health, Inc.
ClinicalTrials.gov Identifier:	NCT00875420 History of Changes
Other Study ID Numbers:	RAD1901-002
First Posted:	April 3, 2009
Results First Posted:	March 26, 2012
Last Update Posted:	March 26, 2012
Last Verified:	October 2011

Keywords provided by Radius Health, Inc.:

hot flashes; hot flushes; vasomotor symptoms; postmenopausal

Additional relevant MeSH terms:

Hot Flashes; Signs and Symptoms