Carotid Artery Intima-Media Thickness Following Exposure to Raloxifene or Placebo

Lilly

Status and phase

Completed

Phase 4

Conditions

Osteoporosis, Post-Menopausal

Treatments

Drug: raloxifene

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

8135

H3S-MC-GGLE

Details and patient eligibility

About

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

Enrollment

147 patients

Sex

Female

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must have completed the Eli Lilly and Company clinical trial CORE (H3S-MC-GGJY) inclusive of visit 5, in one of the 9 participating study sites in California.
Patients must have been dispensed study drug in the CORE trial (H3S-MC-GGJY).

Exclusion criteria

Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
Have previously withdrawn from this exploratory study or any other study investigating raloxifene
Are employed by Eli Lilly and Company (that is, employees, temporary contract workers, or designees responsible for the conduct the study). Immediate family of Eli Lilly and Company employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at an Eli Lilly and Company facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted