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

This study is currently recruiting participants.

Verified by Radius Health, April 2009

First Received: March 6, 2009 Last Updated: April 2, 2009 History of Changes

Sponsored by:	Radius Health
Information provided by:	Radius Health
ClinicalTrials.gov Identifier:	NCT00875420

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 Vasomotor Symptoms	Drug: RAD1901 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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:

Primary Outcome Measures:

Hot flash frequency and severity [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine the safety and tolerability of RAD1901 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

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

Arms	Assigned Interventions
1: Experimental RAD1901	Drug: RAD1901 Oral Once a day
Placebo: Placebo Comparator None	Drug: Placebo Oral

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.

Contacts and Locations

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

Contacts

Contact: Clinical Operations

617-551-4700

Locations

United States, Massachusetts
Radius Health	Recruiting
Cambridge, Massachusetts, United States, 02139

Sponsors and Collaborators

Radius Health

Investigators

Study Director:

Medical Director

Radius Health, Inc.

More Information

No publications provided

Responsible Party:	Radius Health, Inc. ( Program Director )
Study ID Numbers:	RAD1901-002
Study First Received:	March 6, 2009
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00875420 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Radius Health:

hot flashes
hot flushes
vasomotor symptoms
postmenopausal

Study placed in the following topic categories:

Signs and Symptoms
Hot Flashes
Flushing

Additional relevant MeSH terms:

Signs and Symptoms
Hot Flashes

ClinicalTrials.gov processed this record on September 11, 2009