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

Phase 2

Completed

• Conditions: Hot Flashes
• Interventions: Drug: RAD1901; Drug: Placebo

• Registration Number: NCT00875420
• Lead Sponsor: Radius Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-06
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Primary Completion: 2010-01
• Study Completion: 2010-04
• Results First Submitted: 2011-02-16
• Results First Submitted QC: 2012-02-22
• Results First Posted: 2012-03-26
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RAD1901 100 mg	RAD1901	Oral once a day for 28 days
Placebo	Placebo	Oral once a day for 28 days
RAD1901 50 mg	RAD1901	Oral once a day for 28 days
RAD1901 10 mg	RAD1901	Oral once a day for 28 days
RAD1901 25 mg	RAD1901	Oral once a day for 28 days

Primary Outcome Measures

Name	Time	Method
Percent Change in Composite Score Over Time	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.
Percent Change in Frequency of Hot Flashes Over Time	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Radius Health, Inc.; 🇺🇸 Cambridge, Massachusetts, United States