Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420)

Women left out

• No pregnant women

  Women who were pregnant could not join.

  “Women who are pregnant or nursing.”

• Had to use birth control

  Women who couldn't or didn't want to use birth control were turned away.

  “Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control.”

• No hormonal birth control

  Women on the pill, patch, ring, shot, implant or hormonal IUD could not join.

  “Female subject receiving hormonal therapy, including hormone replacement, any estrogen antagonist/agonist, or oral contraceptives.”

• No hormone therapy

  Women taking menopause hormones or gender-affirming hormones could not join.

  “…\] above upper limit of normal). Subjects with a history of hypothyroidism who are on a stable therapy of thyroid hormone replacement for at least 6 weeks are eligible for enrollment if TSH levels are within normal limits before enrollment.”

• Only women past menopause

  Women who could still get pregnant were turned away.

  “Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control.”

• Weight limit (BMI)

  Women with a higher (or lower) body weight were turned away.

  “Subjects whose body mass index (BMI=weight \[kg\]/height2 \[m\]) is \>=30 kg/m2 at Visit 3 (Baseline Visit).”

• No heart disease

  Women with heart disease, heart rhythm problems or a past heart attack were turned away.

  “Congestive heart failure defined by NYHA as Class III or IV.”

• No diabetes

  Women with diabetes were turned away.

  “Uncontrolled (as determined by fasting glucose \>180 mg/mL or HbA1c \>9%) or newly diagnosed (within 1 month of study entry) diabetes mellitus.”

• No mental health conditions

  Women with depression, bipolar disorder or other mental health conditions were turned away.

  “History of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy.”

• No cancer

  Women with current or past cancer were turned away.

  “Cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas).”

Study titles and rules are shown in their original English.