Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Tamoxifen Pharmacogenetics and Clinical Effects

Lead Sponsor:

National Institute of General Medical Sciences (NIGMS)

Collaborating Sponsors:

Indiana University School of Medicine

Conditions:

Breast Cancer

Eligibility:

FEMALE

18-70 years

Brief Summary

The purpose of this research is to try to identify which women who take tamoxifen are likely to suffer from hot flashes or are more likely to have other side effects or benefits from the drug. The res...

Detailed Description

The study will test the following hypotheses. 1. There is a relationship between genetically distinct metabolic profiles of tamoxifen and the frequency and severity of hot flashes in women on chronic...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 18-years or older
  • Women with a prior breast cancer or who are at a high risk for developing the disease and about to start tamoxifen therapy.
  • Participants must not be treated with concomitant chemotherapy or hormone therapy other than tamoxifen. They must not have ovarian ablation or currently being treated with radiation therapy and/or chronic corticosteroids.
  • The participant must not be taking anti-hot flash therapy (clonidine, bellergal, megestrol acetate). Vitamin E, selective serotonin reuptake inhibitors, or herbal remedies are allowed provided that the participant has been taking the remedy for at least 4 weeks and intends to continue the remedy for at least the first month while on the study, and allows for one-month follow up evaluation (hot flash diaries and blood samples).
  • The participant must not be pregnant or lactating.
  • The participant is able and willing to sign an informed consent.

Exclusion

    Key Trial Info

    Start Date :

    September 1 2002

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2007

    Estimated Enrollment :

    297 Patients enrolled

    Trial Details

    Trial ID

    NCT00228930

    Start Date

    September 1 2002

    End Date

    August 1 2007

    Last Update

    September 25 2008

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    Indiana University

    Indianapolis, Indiana, United States, 46202

    2

    UMCCC

    Ann Arbor, Michigan, United States, 48109