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

Overview

Información sobre este estudio

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).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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: 

  • Contra indication to hormone therapy.
  • Chemotherapy or radiation therapy in the preceding 3 months.  (only applicable to those participating in the cardiovascular testing)
  • Current using tobaccom, or past use in preceding 12 months.  (only applicable to those participating in the cardiovascular testing)
  • Current use of medication that alters autonomic or vascular function (e.g. α-blockers, β-blockers, etc.).  (only applicable to those participating in the cardiovascular testing)
  • 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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Ekta Kapoor, M.B.B.S.

Cerrado para la inscripción

Contact information:

Shawn Fokken CCRP

(507) 293-2740

Fokken.Shawn@mayo.edu

More information

Publicaciones

Publications are currently not available
.
CLS-20451789

Mayo Clinic Footer