Effects of lower doses of conjugated equine estrogens and medroxyprogesterone acetate on endometrial bleeding.
OBJECTIVE
To evaluate vaginal bleeding profiles with lower doses of conjugated equine estrogens (CEE) and medroxyprogesterone acetate (MPA) as continuous combined therapy.


METHODS
The Women's Health, Osteoporosis, Progestin, Estrogen (Women's HOPE) study, a randomized, double-blind, placebo-controlled trial.


METHODS
Study centers across the United States.


METHODS
Two thousand six hundred seventy-three healthy, postmenopausal women.


METHODS
Women received CEE, 0.625 mg/d; CEE, 0.625 mg/d, plus MPA 2.5 mg/d; CEE, 0.45 mg/d; CEE, 0.45 mg/d, plus MPA, 2.5 mg/d; CEE 0.45 mg/d, plus MPA, 1.5 mg/d; CEE, 0.3 mg/d; CEE, 0.3 mg/d, plus MPA, 1.5 mg/d; or placebo for 1 year.


METHODS
Bleeding data were analyzed in efficacy-evaluable and intention-to-treat populations.


RESULTS
Cumulative amenorrhea and no bleeding rates were higher with lower doses of CEE/MPA than with CEE 0.625/MPA 2.5. A linear trend between time since menopause and cumulative amenorrhea was observed (P<.05) in all CEE/MPA groups except the CEE 0.45/MPA 1.5 group. The proportion of patients who experienced no bleeding in cycle 1 was 89%, 82%, and 80% in the CEE 0.3/MPA 1.5, CEE 0.45/MPA 1.5, and CEE 0.45/MPA 2.5 groups, respectively. These values were significantly greater than the incidence of no bleeding in the CEE 0.625/MPA 2.5 group (P<.05).


CONCLUSIONS
Lower-dose regimens of CEE and MPA produce higher rates of amenorrhea and no bleeding compared with CEE 0.625/MPA 2.5 and may be appropriate for newly menopausal patients.
Archer
D F
DF
Jones Institute for Reproductive Medicine, Norfolk, Virginia 23507, USA. archerdf@evms.edu
Dorin
M
M
Lewis
V
V
Schneider
D L
DL
Pickar
J H
JH
D000568:Amenorrhea / Q000503:physiopathology; D000818:Animals; D015331:Cohort Studies; D004311:Double-Blind Method; D004717:Endometrium / Q000098:blood supply*; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D006736:Horses; D006801:Humans; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage* / Q000009:adverse effects*; D016896:Treatment Outcome; D014592:Uterine Hemorrhage / Q000503:physiopathology*
D004966:Estrogens, Conjugated (USP); D017258:Medroxyprogesterone Acetate