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

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

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

Study Overview

• Status: Completed
• Conditions: Hot Flashes
• Intervention / Treatment: Drug: RAD1901; Drug: RAD1901; Drug: RAD1901; Drug: RAD1901; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / 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.; Drug: RAD1901; 25 mg Oral once a day for 28 days; Drug: RAD1901; 50 mg Oral once a day for 28 days.; Drug: RAD1901; 100 mg Oral once a day for 28 days
Experimental: RAD1901 25 mg; Oral once a day for 28 days	Drug: RAD1901; 10 mg Oral once a day for 28 days.; Drug: RAD1901; 25 mg Oral once a day for 28 days; Drug: RAD1901; 50 mg Oral once a day for 28 days.; Drug: RAD1901; 100 mg Oral once a day for 28 days
Experimental: RAD1901 50 mg; Oral once a day for 28 days	Drug: RAD1901; 10 mg Oral once a day for 28 days.; Drug: RAD1901; 25 mg Oral once a day for 28 days; Drug: RAD1901; 50 mg Oral once a day for 28 days.; Drug: RAD1901; 100 mg Oral once a day for 28 days
Experimental: RAD1901 100 mg; Oral once a day for 28 days	Drug: RAD1901; 10 mg Oral once a day for 28 days.; Drug: RAD1901; 25 mg Oral once a day for 28 days; Drug: RAD1901; 50 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Radius Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: March 6, 2009
• First Submitted That Met QC Criteria: April 2, 2009
• First Posted (Estimate): April 3, 2009

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: vasomotor symptoms; postmenopausal; hot flashes; hot flushes
• Additional Relevant MeSH Terms: Hot Flashes
• Other Study ID Numbers: RAD1901-002