Oophorectomy, Estrogen Therapy and Cardiovascular Disease Risk in Young Women

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

Researchers are trying to assess the appropriate dose of estrogen for decreasing the risk of cardiovascular disease in women who have removal of their ovaries at a young age, before the age of 46 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate

Criteria

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 timed control group

• Currently between the ages of 21- 45 years

• 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 Timed 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 Intra Uterine Device, Hysterectomy, Tubal ligation, Abstinence (no sex)

• Any condition or factor judged by the investigator to preclude participation in the study