Oophorectomy, Estrogen Therapy and Cardiovascular Disease Risk in Young Women

Cardiovascular Risk Reduction Clinical Trial

Official title:

Impact of Individualized Estrogen Therapy on Cardiovascular Disease Risk Parameters in Young Women After Bilateral Oophorectomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03815929
• Other study ID #: 18-007999
• Status: Completed
• Phase: Phase 2
• Start date: March 15, 2019
• Est. completion date: August 28, 2023

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 undergo study specific procedures including a urine pregnancy test if they are of child bearing potential. Participants will also complete a set of questionnaires. After the completion of the study tests, participants will be offered a meal. Participants scheduled for surgery to remove their ovaries: after the surgery subjects will be randomized to one of two groups. They will receive the standard dose of the hormone (estrogen) patch, generally prescribed to patients after removal both ovaries. Or sent home on the standard dose hormone patch, hormone levels will be tested every 3-4 weeks, and patch dose adjusted until the estrogen level is reached that results in the hormone levels of a young woman before menopause. In order to check hormones, subjects will be able to choose to have a lab kit sent to them and have the draw done locally, or can come in person. Participants will also receive a second hormone prescription if they have an intact uterus to protect the lining of the uterus from the effects of using estrogen alone. 6-Month Study Visit: Subjects will be asked to come back and repeat most of the study specific tests from the baseline study visit that will take about 5 hours. 1-Year Study Visit: Subjects will be asked to come back for the final visit and will repeat all the study tests done at baseline visit. This visit will take about 5 hours. Control Group: Healthy subjects serving as controls to see how measures change over time will not undergo a surgery or be given estrogen. These healthy subjects will return after the baseline visit to repeat study visits at 6 and 12-months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 28, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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, a-blockers, ß-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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Reduction

Intervention

Drug:
• Estradiol 100 Micrograms Patch
Standard
• Estradiol Patch
Individualized

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Endothelial function	Brachial artery flow mediated dilation using ultrasonography to measure any endothelium dysfunction occurring over 12 months.	Baseline, 6 months, and 12 months
Primary	Change in cerebral vascular reactivity	Changes to the middle cerebral artery blood flow velocity measured using a Multigon Trans-Cranial Doppler sonogram probe monitoring with three stepwise end-tidal carbon dioxide elevations of constant concentration levels with 3 minutes at each level is compared over planned time frames.	Baseline, 6 months, and 12 months
Secondary	Change in Arterial tonometry	Arterial stiffness is recorded through high-fidelity pressure waveforms and compared at planned time frames	Baseline, 6 months, and 12 months
Secondary	Changes in maximal Voluntary Contraction of the non-dominant arm	Isometric handgrip exercise squeezing a transducer with goal of consistently maintaining a moderate workload average over 5 attempts and compared over time.	Baseline, 6 months, and 12 months
Secondary	Changes to the index of baroreflex sensitivity	Colder pressor test immersing hand up to wrist in ice water while changes in blood pressure and heart rate are monitored and compared over time frames.	Baseline, 6 months, and 12 months
Secondary	Changes in measurements of whole body and regional fat and fat-free mass	Measurements will be taken using Dual energy x-ray absorptiometry (DXA) scans and compared over time and between the groups.	Baseline and 12 months

External Links

•   Mayo Clinic Clinical Trials