Ethinyl Estradiol and Norgestrel |
Cryselle; Lo/Ovral; Low-Ogestrel; Ogestrel; Ovral-28 |
Clinical Trial: Estrogen Alternatives Study
This study is currently recruiting patients.
|
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
Study start: April 2003; Expected completion: December 2006
Eligibility
Genders Eligible for Study: Female
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
- Postmenopausal women (no menses for greater than or equal to 12 months, or s/p [status post] hysterectomy with bilateral ovariectomy) not currently taking hormone replacement therapy (within previous 3 months)
- Normal mammogram within previous 12 months
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
Michigan
VA Ann Arbor Healthcare System, Ann Arbor, Michigan, 48105, United States; Recruiting
Claire Duvernoy, M.D., Principal Investigator
Claire Duvernoy, M.D., Principal Investigator
More Information
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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