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Completed

NCT Number: NCT00875420

A 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.

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Key information

Conditions

Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Radius Health, Inc.

Cambridge, Massachusetts, 02139, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RAD1901

Drug

10 mg Oral once a day for 28 days.

Placebo

Drug

Placebo Oral once a day for 28 days

Primary outcomes

  1. Percent Change in Frequency of Hot Flashes Over Time

    Time frame: 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.

  2. Percent Change in Composite Score Over Time

    Time frame: 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.

Secondary outcomes

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

    Time frame: Day 29 minus baseline

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

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

    Time frame: Day 29 minus baseline

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

Sponsors and collaborators

Lead sponsor

Radius Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 3, 2009
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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