To evaluate the efficacy of lower doses of conjugated equine estrogens (CEE) plus
medroxyprogesterone acetate (MPA) for relieving vasomotor symptoms and vaginal atrophy.
A randomized, double-blind, placebo-controlled trial (the Women's Health, Osteoporosis,
Progestin, Estrogen study).
Study centers across the United States.
Two thousand, six hundred, seventy-three healthy, postmenopausal women with an intact
uterus, including an efficacy-evaluable population (n = 241 at baseline).
Patients received for 1 year (13 cycles; in milligrams per day) CEE, 0.625; CEE, 0.625
and MPA, 2.5; CEE, 0.45; CEE, 0.45 and MPA, 2.5; CEE, 0.45 and MPA, 1.5; CEE, 0.3;
CEE, 0.3 and MPA, 1.5; or placebo.
Number and severity of hot flushes and Papanicolaou smear with vaginal maturation
index (VMI) to assess vaginal atrophy.
In the efficacy-evaluable population, reduction in vasomotor symptoms was similar
with CEE of 0.625 mg/d and MPA of 2.5 mg/d (the most commonly prescribed doses) and
all lower combination doses. CEE of 0.625 mg/d alleviated hot flushes more effectively
than the lower doses of CEE alone. VMI improved in all active treatment groups.
Lower doses of CEE plus MPA relieve vasomotor symptoms and vaginal atrophy as effectively
as commonly prescribed doses.