Oophorectomy, Estrogen Therapy and Cardiovascular Disease Risk in Young Women
Condition: Cardiovascular Risk Reduction
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): Estradiol 100 Micrograms Patch; Estradiol Patch
Intervention type(s): Drug; Drug
Intervention description(s): Standard; Individualized
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
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)
Primary purpose: Prevention
Keywords: Hormone therapy; Pre-menopausal Oophorectomy; Cardiovascular Disease