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

Primary Purpose

Hot Flashes

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

RAD1901

Placebo

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring hot flashes, hot flushes, vasomotor symptoms, postmenopausal

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Radius Health, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

RAD1901 10 mg

RAD1901 25 mg

RAD1901 50 mg

RAD1901 100 mg

Placebo

Arm Description

Oral once a day for 28 days

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT00875420

First Posted

March 6, 2009

Last Updated

August 29, 2018

Sponsor

Radius Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00875420

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radius Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hot Flashes

Keywords

hot flashes, hot flushes, vasomotor symptoms, postmenopausal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RAD1901 10 mg

Arm Type

Experimental

Arm Description

Oral once a day for 28 days

Arm Title

RAD1901 25 mg

Arm Type

Experimental

Arm Description

Oral once a day for 28 days

Arm Title

RAD1901 50 mg

Arm Type

Experimental

Arm Description

Oral once a day for 28 days

Arm Title

RAD1901 100 mg

Arm Type

Experimental

Arm Description

Oral once a day for 28 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Oral once a day for 28 days

Intervention Type

Drug

Intervention Name(s)

RAD1901

Intervention Description

10 mg Oral once a day for 28 days.

Intervention Type

Drug

Intervention Name(s)

RAD1901

Intervention Description

25 mg Oral once a day for 28 days

Intervention Type

Drug

Intervention Name(s)

RAD1901

Intervention Description

50 mg Oral once a day for 28 days.

Intervention Type

Drug

Intervention Name(s)

RAD1901

Intervention Description

100 mg Oral once a day for 28 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo Oral once a day for 28 days

Primary Outcome Measure Information:

Title

Percent Change in Frequency of Hot Flashes Over Time

Description

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.

Time Frame

Week 4 minus baseline week

Title

Percent Change in Composite Score Over Time

Description

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.

Time Frame

Week 4 minus baseline week

Secondary Outcome Measure Information:

Title

Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time.

Description

Percent change in FSH at Day 29 compared to baseline, in the intent-to-treat population.

Time Frame

Day 29 minus baseline

Title

Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time.

Description

Percent change in LH levels at Day 29 compared to baseline, in the intent-to-treat population.

Time Frame

Day 29 minus baseline

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Radius Health, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Radius Health, Inc.

City

Cambridge

State/Province

Massachusetts

ZIP/Postal Code

02139

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27575546

Citation

Hattersley G, Harris AG, Simon JA, Constantine GD. Clinical investigation of RAD1901, a novel estrogen receptor ligand, for the treatment of postmenopausal vasomotor symptoms: a phase 2 randomized, placebo-controlled, double-blind, dose-ranging, proof-of-concept trial. Menopause. 2017 Jan;24(1):92-99. doi: 10.1097/GME.0000000000000726.

Results Reference

derived

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

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