Status:
COMPLETED
Oophorectomy, Estrogen Therapy and Cardiovascular Disease Risk in Young Women
Lead Sponsor:
Mayo Clinic
Conditions:
Cardiovascular Risk Reduction
Eligibility:
FEMALE
21-45 years
Phase:
PHASE2
Brief 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 year...
Detailed Description
Baseline Study Visit: Subjects will report for the Baseline Study Day in an 8 hour fasting state (water only) and refrain from heavy exercise, caffeine, and alcohol for 24 hours. The participant will ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2023
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03815929
Start Date
March 15 2019
End Date
August 28 2023
Last Update
October 23 2024
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55902