A Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women - Full Text View

Purpose

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

Condition	Intervention	Phase
Hot Flashes	Drug: RAD1901 Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Radius Health, Inc.:

Primary Outcome Measures:

Percent Change in Frequency of Hot Flashes Over Time [ Time Frame: Week 4 minus baseline week ] [ Designated as safety issue: No ]
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 [ Time Frame: Week 4 minus baseline week ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 29 minus baseline ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 29 minus baseline ] [ Designated as safety issue: No ]
Percent change in LH levels at Day 29 compared to baseline, in the intent-to-treat population.


Enrollment:	100
Study Start Date:	March 2009
Study Completion Date:	April 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875420

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


Responsible Party:	Radius Health, Inc.
ClinicalTrials.gov Identifier:	NCT00875420 History of Changes
Other Study ID Numbers:	RAD1901-002
Study First Received:	March 6, 2009
Results First Received:	February 16, 2011
Last Updated:	February 22, 2012
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Radius Health, Inc.:


hot flashes hot flushes vasomotor symptoms postmenopausal

Additional relevant MeSH terms:


Hot Flashes Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2016