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Estrogen Alternatives Study - Article


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Drospirenone and Ethinyl Estradiol

drospirenone 3.0mg and ethinyl estradiol 0.030mg; Yasmin


Clinical Trial: Estrogen Alternatives Study

This study is currently recruiting patients.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs

Purpose

Healthy postmenopausal women not currently taking hormone replacement or hormone modulating therapy take a 3-month course of estradiol/raloxifene/placebo to evaluate the effects of each on vascular function, as indicated by PET coronary flow reserve studies and brachial artery ultrasound, before and after use of the therapies. This is a randomized, placebo-controlled, blinded study.

Condition Treatment or Intervention Phase
Healthy
 Drug: Estradiol followed by progesterone
 Drug: Raloxifene
Phase IV

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Official Title: Estrogen Alternatives and Vascular function in Post-Menopausal Women

Further Study Details: 

Study start: April 2003;  Expected completion: December 2006

Eligibility

Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Exclusion Criteria:

  • Current or recent (within previous 3 months) hormone replacement therapy
  • Current or recent (within previous 3 months) use of hormone alternatives such as raloxifene, tamoxifen, or soy estrogen preparations.
  • LDL Cholesterol > 160 mg/dl.
  • History of hypertension, diabetes mellitus, peripheral vascular disease, cerebrovascular disease, current smoking, history of DVT (deep vein thrombosis) or PE (pulmonary embolism), active gallbladder disease, family history of premature (men under 55 yrs, women under 65 yrs) coronary artery disease
  • History of breast, uterine, or ovarian cancer Contraindication to adenosine administration (i.e., significant bronchospastic pulmonary disease, higher degree heart block)
  • Inability to give informed consent
  • Inability to temporarily (for 24 hours) discontinue potential vasoactive drugs, such as anti-inflammatory agents and aspirin, at least 24 hours prior to the examinations.
  • History of coronary heart disease

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00108238


Michigan
      VA Ann Arbor Healthcare System, Ann Arbor,  Michigan,  48105,  United States; Recruiting
Jill Rothley  734-936-5536    rothley@umich.edu 
Claire Duvernoy, M.D.,  Principal Investigator

Study chairs or principal investigators

Claire Duvernoy, M.D.,  Principal Investigator

More Information

Study ID Numbers:  CLIN-001-02F
Record last reviewed:  April 2005
Last Updated:  April 15, 2005
Record first received:  April 14, 2005
ClinicalTrials.gov Identifier:  NCT00108238
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-03


Source: ClinicalTrials.gov
Cache Date: May 4, 2005


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September 8, 2008



Page Updated: September 6, 2005
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