Phase 2
N=35
Oophorectomy, Estrogen Therapy and Cardiovascular Disease Risk in Young Women
Cardiovascular Risk Reduction
Bottom Line
View on ClinicalTrials.gov: NCT03815929 ↗Enrolled (actual)
35
Serious AEs
11.4%
Results posted
Oct 2024
Primary outcome: Primary: Arterial Stiffness — 10.1; 14.8; 6.4; 12.7 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Estradiol 100 Micrograms Patch (Drug); Estradiol Patch (Drug)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arterial Stiffness |
10.1; 14.8; 6.4; 12.7; 16.8; 5.1 | — |
| SECONDARY Mean Blood Pressure Reactivity to Isometric Hand Grip Exercise |
11.6; 11.4; 8.3; 11.7; 15.3; 10.7 | — |
| SECONDARY Mean Blood Pressure Reactivity to Cold Stress |
22; 20; 20; 21; 25; 18 | — |
| SECONDARY Changes in Whole Body Fat |
30712; 43363; 199936; 31868; 42660; 16735 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03815929). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.