A two-year, double-blind comparison of estrogen-androgen and conjugated estrogens in surgically menopausal women. Effects on bone mineral density, symptoms and lipid profiles.
OBJECTIVE
To compare the effects of two doses of conjugated equine estrogen (CEE) and two of esterified estrogen plus methyltestosterone (E + A) in surgically menopausal women.


METHODS
A two-year, parallel-group, double-blind study of 311 women who were randomly assigned to one of four regimens: (1) CEE, 0.625 mg/d; (2) CEE, 1.25 mg/d; (3) esterified estrogens, 0.625 mg, + methyltestosterone, 1.25 mg/d; or (4) esterified estrogens, 1.25, + methyltestosterone, 2.5 mg/d. Study parameters were symptoms, lipids, bone mineral density, side effects and safety.


RESULTS
All treatments prevented loss of bone in the spine and hip. The higher E + A dose increased spine and hip BMD more than other treatments (P < .002). All treatments improved menopausal symptoms, with non-significantly greater improvements in well-being and sexual interest in the E + A groups. Similar and significant decreases in low-density lipoprotein were observed in all groups, but high-density lipoprotein and triglycerides were increased only in the unopposed estrogen groups (P < .05). Hirsutism was uncommon and similar in all groups at two years. Discontinuation rates and reasons for withdrawal from the study were similar in both groups. No clinically significant side effects or laboratory test abnormalities were seen.


CONCLUSIONS
As compared to estrogen alone, E + A significantly improved BMD and was well tolerated in surgically menopausal women.
Barrett-Connor
E
E
Department of Family and Preventive Medicine, University of California, San Diego, School of Medicine, La Jolla 92093-0607, USA.
Young
R
R
Notelovitz
M
M
Sullivan
J
J
Wiita
B
B
Yang
H M
HM
Nolan
J
J
D000284:Administration, Oral; D000328:Adult; D015519:Bone Density / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004857:Equilin / Q000494:pharmacology / Q000627:therapeutic use*; D004966:Estrogens, Conjugated (USP) / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D020249:Hormone Replacement Therapy; D006801:Humans; D007989:Libido / Q000187:drug effects; D008055:Lipids / Q000097:blood*; D008593:Menopause; D008777:Methyltestosterone / Q000494:pharmacology / Q000627:therapeutic use*; D008875:Middle Aged; D010052:Ovariectomy; D011788:Quality of Life; D045165:Testosterone Congeners / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
D004966:Estrogens, Conjugated (USP); D008055:Lipids; D045165:Testosterone Congeners; D004857:Equilin; D008777:Methyltestosterone