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| Sponsor: | Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00532246 |
Purpose
The purpose of this study is to measure carotid artery IMT at a single visit in a subset of women previously enrolled in the CORE (H3S-MC-GGJY) trial
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis, Post-Menopausal |
Drug: raloxifene Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Study of Carotid Artery Intima-Media Thickness Following Exposure to Raloxifene HCl or Placebo |
| Enrollment: | 147 |
| Study Start Date: | March 2003 |
| Study Completion Date: | August 2003 |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
raloxifene
|
Drug: raloxifene |
|
B: Placebo Comparator
placebo
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Walnut Creek, California, United States | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| San Diego, California, United States | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Menlo Park, California, United States | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| La Jolla, California, United States | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Oakland, California, United States | |
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST | Eli Lilly and Company |
More Information
| Study ID Numbers: | 8135, H3S-MC-GGLE |
| Study First Received: | September 18, 2007 |
| Last Updated: | September 18, 2007 |
| ClinicalTrials.gov Identifier: | NCT00532246 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Estrogen Antagonists Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis Bone Diseases, Metabolic Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Bone Diseases Pharmacologic Actions Estrogen Receptor Modulators Raloxifene Musculoskeletal Diseases Osteoporosis, Postmenopausal |