Oophorectomy, Estrogen Therapy and Cardiovascular Disease Risk in Young Women
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|ClinicalTrials.gov Identifier: NCT03815929|
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : August 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Risk Reduction||Drug: Estradiol 100 Micrograms Patch Drug: Estradiol Patch||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Factorial Assignment|
|Intervention Model Description:||Subject be placed into three different study arms. Subjects undergoing surgery will be randomized to receive either standard hormone therapy or individualized hormone therapy. These arms will be compared against each other as well as a third arm of healthy timed-control subjects|
|Masking:||None (Open Label)|
|Official Title:||Impact of Individualized Estrogen Therapy on Cardiovascular Disease Risk Parameters in Young Women After Bilateral Oophorectomy: A Randomized Controlled Trial|
|Actual Study Start Date :||March 15, 2019|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||November 2023|
Active Comparator: Standard replacement therapy regimen
100 mcg transdermal estradiol patch (or equivalent oral dose)
Drug: Estradiol 100 Micrograms Patch
Active Comparator: Titrated replacement therapy regimen
Transdermal estradiol patch (or equivalent oral dose) titrated to achieve pre-menopausal estradiol level
Drug: Estradiol Patch
No Intervention: Timed Control Group
Healthy age-matched subjects not on hormone therapy
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815929
|Contact: Shawn C Fokken, BS, CCRPfirstname.lastname@example.org|
|Contact: Pamela A. Engravemail@example.com|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55902|
|Contact: Shawn C Fokken 507-293-2740 firstname.lastname@example.org|
|Contact: Pam Engrav 507-775-6938 email@example.com|
|Principal Investigator: Ekta Kapoor, MBBS|
|Principal Investigator:||Ekta Kapoor, MBBS||Mayo Clinic|