Oophorectomy, Estrogen Therapy and Cardiovascular Disease Risk in Young Women

NCT03815929 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 18-007999
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Risk Reduction

Keywords

Hormone therapy; Pre-menopausal Oophorectomy; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Arterial Stiffness

  Augmented pressure, a measure of arterial stiffness was recorded through high-fidelity pressure waveforms and compared at planned time frames

  Baseline, 6 months, and 12 months

Secondary Outcomes (3)

• Mean Blood Pressure Reactivity to Isometric Hand Grip Exercise

  Baseline, 6 months, and 12 months

• Mean Blood Pressure Reactivity to Cold Stress

  Baseline, 6 months, and 12 months

• Changes in Whole Body Fat

  Baseline and 12 months

Study Arms (3)

Standard replacement therapy regimen

ACTIVE COMPARATOR

100 mcg transdermal estradiol patch (or equivalent oral dose)

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

Drug: Estradiol Patch

Timed Control Group

NO INTERVENTION

Healthy age-matched subjects not on hormone therapy

Interventions

Estradiol 100 Micrograms Patch DRUG

Standard

Standard replacement therapy regimen

Estradiol Patch DRUG

Individualized

Titrated replacement therapy regimen

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Ortho Evra

Results Point of Contact

• Title: Dr. Ekta Kapoor
• Organization: Principle Investigator

kapoor.ekta@mayo.edu

507 538-7103

Study Officials

• Ekta Kapoor, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 24, 2019
• Study Start: March 15, 2019
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-10

Locations

US (1)