Oophorectomy, Estrogen Therapy and Cardiovascular Disease Risk in Young Women

What this trial studies

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.

Conditions in scope

• Cardiovascular Risk Reduction

Interventions

• Estradiol 100 Micrograms Patch (Drug) — Standard
• Estradiol Patch (Drug) — Individualized

Who can join

Women only · Ages 21 Years to 45 Years · Accepts healthy volunteers.

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)

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE2
• Start date: 2019-03-15
• Primary completion: 2023-08-28
• Last update posted: 2024-10-23
• First posted: 2019-01-24

Sponsor & contact

Lead sponsor: Mayo Clinic (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Arterial Stiffness (Baseline, 6 months, and 12 months)
  Augmented pressure, a measure of arterial stiffness was recorded through high-fidelity pressure waveforms and compared at planned time frames

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.