A Study to Determine the Impact of Individualized Estrogen Therapy on Cardiovascular Disease Risk Parameters in Young Women after Bilateral Oophorectomy

Overview

About this study

The purpose of this study is to compare the cardiovascular function in young women (<46 years) following bilateral oophorectomy who are treated with either the standard dose of estradiol (100 mcg transdermal patch or equivalent oral dose) or titrated estradiol dosing to achieve average premenopausal estradiol level (80-120 pg/ml), to characterize the relationship between the serum estradiol level and cardiovascular function in young women (<46 years) on estradiol replacement after bilateral oophorectomy, and to compare the body composition in young women following bilateral oophorectomy who are treated with either the standard dose of estradiol (100 mcg transdermal patch or equivalent oral dose) or titrated estradiol dosing to achieve average premenopausal estradiol level (80-120 pg/ml).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:   

  • Premenopausal women undergoing (or completion of a) bilateral oophorectomy for non-malignant diagnoses at Mayo Clinic, Rochester; or premenopausal women not undergoing the procedure for the time control group.
  • Currently between the ages of 21- 45 years old.
  • Able to participate fully in all aspects of the study.
  • Able to understand and sign the informed consent.

Exclusion Criteria: 

  • History of hepatic, renal, or hematological diseases.
  • History of venous thromboembolism; peripheral vascular disease; coronary artery disease; stroke/neurovascular disease.
  • Chemotherapy or radiation therapy in the preceding 3 months.
  • Current tobacco use.
  • Current use of medication that alters autonomic or vascular function (e.g. tricyclic antidepressants, α-blockers, β-blockers, etc.) or aromatase inhibitor/tamoxifen therapy.
  • Contra-indication to estrogen use.
  • Current or previous diagnosis of breast and endometrial cancer.
  • For Time Controls:
    • Are currently pregnant or lactating, or are of child-bearing potential or are likely to become pregnant during the study and unwilling to use contraception.  Acceptable forms include:
      • Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm);
      • Copper IUD;
      • Hysterectomy;
      • Tubal ligation;
      • Abstinence (no sex);
  • Any condition or factor judged by the investigator to preclude participation in the study.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ekta Kapoor, M.B.B.S.

Open for enrollment

Contact information:

Shawn Fokken CCRP

(507)293-2740

Fokken.Shawn@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20451789

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