NCT00875420

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2009

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 26, 2012

Completed
Last Updated

September 26, 2018

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

March 6, 2009

Results QC Date

February 16, 2011

Last Update Submit

August 29, 2018

Conditions

Hot Flashes

Keywords

hot flasheshot flushesvasomotor symptomspostmenopausal

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

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

    Day 29 minus baseline

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

    Day 29 minus baseline

Study Arms (5)

RAD1901 10 mg

EXPERIMENTAL

Oral once a day for 28 days

Drug: RAD1901

RAD1901 25 mg

EXPERIMENTAL

Oral once a day for 28 days

Drug: RAD1901

RAD1901 50 mg

EXPERIMENTAL

Oral once a day for 28 days

Drug: RAD1901

RAD1901 100 mg

EXPERIMENTAL

Oral once a day for 28 days

Drug: RAD1901

Placebo

PLACEBO COMPARATOR

Oral once a day for 28 days

Drug: Placebo

Interventions

RAD1901DRUG

10 mg Oral once a day for 28 days.

RAD1901 10 mg
PlaceboDRUG

Placebo Oral once a day for 28 days

Placebo

Eligibility Criteria

Age40 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have documented evidence of a minimum of 7 moderate to severe hot flashes per day, or 50 per week.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radius Health, Inc.

Cambridge, Massachusetts, 02139, United States

Location

Related Publications (1)

  • 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.

    PMID: 27575546DERIVED

MeSH Terms

Conditions

Hot Flashes

Interventions

RAD1901

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Program Director
Organization
Radius Health, Inc.
info@radiuspharm.com
(617) 551-4700

Study Officials

  • Medical Director

    Radius Health, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2009

First Posted

April 3, 2009

Study Start

March 1, 2009

Primary Completion

January 1, 2010

Study Completion

April 1, 2010

Last Updated

September 26, 2018

Results First Posted

March 26, 2012

Record last verified: 2018-08

Locations

US(1)