Uterine effects of raloxifene in comparison with continuous-combined hormone replacement therapy in postmenopausal women.
OBJECTIVE
We sought to compare the uterine effects of raloxifene with those of continuous-combined hormone replacement therapy.


METHODS
This randomized, double-blind 24-month study involved 136 postmenopausal women who received raloxifene 150 mg/d or conjugated equine estrogens 0.625 mg/d with medroxyprogesterone acetate 2.5 mg/d. After baseline evaluations, endometrial biopsy specimens were obtained, and endometrial thickness was measured annually by means of transvaginal ultrasonography. Statistical analyses were performed with an intention-to-treat approach.


RESULTS
In the raloxifene group at the end point of the study 94.4% of biopsy specimens showed normal benign postmenopausal endometrium and 5.6% were classified as benign stimulatory endometrium. In the continuous-combined hormone replacement therapy group at the end point of the study 78.7% of biopsy specimens showed normal benign postmenopausal endometrium, 19. 1% were classified as benign stimulatory endometrium, and 2.1% showed benign abnormal postmenopausal endometrium. Mean endometrial thickness was unchanged from baseline with raloxifene and was increased significantly by 0.5 mm at 12 months with continuous-combined hormone replacement therapy.


CONCLUSIONS
Raloxifene 150 mg/d did not increase endometrial thickness or cause endometrial proliferation in healthy postmenopausal women.
Fugère
P
P
Department of Obstetrics and Gynecology, University of Montreal, Hôpital Saint-Luc, Montreal, Quebec, Canada.
Scheele
W H
WH
Shah
A
A
Strack
T R
TR
Glant
M D
MD
Jolly
E
E
D001706:Biopsy; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004717:Endometrium / Q000187:drug effects; D004965:Estrogen Antagonists / Q000627:therapeutic use*; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D020249:Hormone Replacement Therapy; D006801:Humans; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D017698:Postmenopause / Q000187:drug effects*; D020849:Raloxifene Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D014463:Ultrasonography; D014599:Uterus / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000473:pathology
D004965:Estrogen Antagonists; D004966:Estrogens, Conjugated (USP); D020849:Raloxifene Hydrochloride; D017258:Medroxyprogesterone Acetate