Oophorectomy, Estrogen Therapy and Cardiovascular Disease Risk in Young Women

September 21, 2023 updated by: Ekta Kapoor, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard replacement therapy regimen
100 mcg transdermal estradiol patch (or equivalent oral dose)
Drug: Estradiol 100 Micrograms Patch
Standard
Active Comparator: Titrated replacement therapy regimen
Transdermal estradiol patch (or equivalent oral dose) titrated to achieve pre-menopausal estradiol level
Drug: Estradiol Patch
Individualized
No Intervention: Timed Control Group
Healthy age-matched subjects not on hormone therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Endothelial function
Time Frame: Baseline, 6 months, and 12 months
Brachial artery flow mediated dilation using ultrasonography to measure any endothelium dysfunction occurring over 12 months.
Baseline, 6 months, and 12 months
Change in cerebral vascular reactivity
Time Frame: Baseline, 6 months, and 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Arterial tonometry
Time Frame: Baseline, 6 months, and 12 months
Arterial stiffness is recorded through high-fidelity pressure waveforms and compared at planned time frames
Baseline, 6 months, and 12 months
Changes in maximal Voluntary Contraction of the non-dominant arm
Time Frame: Baseline, 6 months, and 12 months
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
Changes to the index of baroreflex sensitivity
Time Frame: Baseline, 6 months, and 12 months
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
Changes in measurements of whole body and regional fat and fat-free mass
Time Frame: Baseline and 12 months
Measurements will be taken using Dual energy x-ray absorptiometry (DXA) scans and compared over time and between the groups.
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Ekta Kapoor, MBBS, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2019

Primary Completion (Actual)

August 28, 2023

Study Completion (Actual)

August 28, 2023

Study Registration Dates

First Submitted

January 17, 2019

First Submitted That Met QC Criteria

January 23, 2019

First Posted (Actual)

January 24, 2019

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-007999

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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