Cardiovascular Risk ReductionPhase 2NCT03815929
Oophorectomy, Estrogen Therapy and Cardiovascular Disease Risk in Young Women
A Phase 2 study testing Estradiol 100 Micrograms Patch and Estradiol Patch in people with Cardiovascular Risk Reduction, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Reduction
- What is being tested?
- Estradiol 100 Micrograms Patch and Estradiol Patch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2019to 28 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Risk Reduction
- Being tested
- Estradiol 100 Micrograms Patch, Estradiol Patch
- Keywords
- Hormone therapy, Pre-menopausal Oophorectomy, Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol 100 Micrograms PatchDrug
Standard
Estradiol PatchDrug
Individualized
| Study group | Role | What they receive |
|---|---|---|
| Standard replacement therapy regimen | Active comparator | 100 mcg transdermal estradiol patch (or equivalent oral dose) Receives: Drug: Estradiol 100 Micrograms Patch |
| Titrated replacement therapy regimen | Active comparator | Transdermal estradiol patch (or equivalent oral dose) titrated to achieve pre-menopausal estradiol level Receives: Drug: Estradiol Patch |
| Timed Control Group | No intervention | Healthy age-matched subjects not on hormone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Stiffness
Augmented pressure, a measure of arterial stiffness was recorded through high-fidelity pressure waveforms and compared at planned time frames
Measured: Baseline, 6 months, and 12 months
Secondary outcomes (3)
Mean Blood Pressure Reactivity to Isometric Hand Grip Exercise
Change in mean blood pressure in response to isometric hand grip exercise (30% maximum voluntary contraction)
Measured: Baseline, 6 months, and 12 months
Mean Blood Pressure Reactivity to Cold Stress
Maximum change in mean blood pressure during 3-minute cold pressor test (immersing hand up to wrist in ice water while changes in blood pressure monitored)
Measured: Baseline, 6 months, and 12 months
Changes in Whole Body Fat
Measurements of whole-body fat using Dual energy x-ray absorptiometry (DXA)
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start15 Mar 2019
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular Risk ReductionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekta Kapoor, Mayo Clinic
- Investigators
- Ekta Kapoor, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815929
- Sponsor's protocol ID
- 18-007999
- Status last verified
- Oct 2024
- First submitted
- 17 Jan 2019
- Last updated
- 23 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Individualized Estrogen Therapy on Cardiovascular Disease Risk Parameters in Young Women After Bilateral Oophorectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03815929
- Acronym / sponsor ID
- 18-007999
- Conditions
- Cardiovascular Risk Reduction
- Keywords
- Hormone therapy, Pre-menopausal Oophorectomy, Cardiovascular Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Standard replacement therapy regimen | Active comparator | Drug: Estradiol 100 Micrograms Patch100 mcg transdermal estradiol patch (or equivalent oral dose) |
| Titrated replacement therapy regimen | Active comparator | Drug: Estradiol PatchTransdermal estradiol patch (or equivalent oral dose) titrated to achieve pre-menopausal estradiol level |
| Timed Control Group | No intervention | –Healthy age-matched subjects not on hormone therapy |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estradiol 100 Micrograms PatchStandard | Drug | Standard replacement therapy regimen |
| Estradiol PatchIndividualized | Drug | Titrated replacement therapy regimen |
Primary outcome
Arterial Stiffness
Time frame: 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
3 secondary outcomes
Mean Blood Pressure Reactivity to Isometric Hand Grip Exercise
Time frame: Baseline, 6 months, and 12 months
Mean Blood Pressure Reactivity to Cold Stress
Time frame: Baseline, 6 months, and 12 months
Changes in Whole Body Fat
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekta Kapoor, MBBS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Estradiol 100 Micrograms Patch and Estradiol Patch in people with Cardiovascular Risk Reduction, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Stiffness (time frame: Baseline, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.