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

Hot Flashes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875420
• Other study ID #: RAD1901-002
• Status: Completed
• Phase: Phase 2
• Start date: March 2009
• Est. completion date: April 2010

Study information

• Verified date: August 2018
• Source: Radius Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Drug:
• RAD1901
10 mg Oral once a day for 28 days.
• RAD1901
25 mg Oral once a day for 28 days
• RAD1901
50 mg Oral once a day for 28 days.
• RAD1901
100 mg Oral once a day for 28 days
• Placebo
Placebo Oral once a day for 28 days

Locations

Country	Name	City	State
United States	Radius Health, Inc.	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Radius Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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