Gynecologic and hormonal effects of raloxifene in premenopausal women.
OBJECTIVE
To assess the effects of raloxifene on the ovaries, uterus, and serum hormone levels in premenopausal women.


METHODS
Prospective study comparing pretreatment findings with findings for those on treatment.


METHODS
Government research hospital.


METHODS
Thirty women 35 to 47 years of age who were at high risk of breast cancer and had regular, ovulatory menstrual cycles.


METHODS
Raloxifene (60 mg) and calcium (1,200 mg) daily for 2 years.


METHODS
Sonographic evidence of ovarian stimulation (>or=2 corpora lutea, or follicular cysts of >2 cm, or single follicular cyst of >3 cm). Changes in endometrial thickness, fibroid size, hormone levels, and menstrual-cycle length.


RESULTS
Fifteen subjects developed some cycles with asymptomatic ovarian stimulation, and 9 developed benign endometrial polyps, compared with 2 subjects and 1 subject pretreatment, respectively. Uterine fibroid size was unchanged during raloxifene use in 16 subjects with fibroids. On treatment, E(2) levels increased significantly only during the follicular phase, with peak E(2) levels significantly higher in cycles showing ovarian stimulation compared with those without. Sex hormone-binding globulin increased, but levels of LH, FSH, P, DHEAS, and T did not. Endometrial thickness and cycle length were unchanged.


CONCLUSIONS
Premenopausal subjects receiving raloxifene showed sonographic and hormonal evidence of ovarian stimulation. Endometrial thickness, cycle length, and fibroid size were unchanged. Benign asymptomatic endometrial polyps developed in some.
Premkumar
Ahalya
A
Department of Diagnostic Radiology, Warren G. Magnuson Clinical Center, Bethesda, Maryland, USA. ps79c@nih.gov
Venzon
David J
DJ
Avila
Nilo
N
Johnson
Diane V
DV
Remaley
Alan T
AT
Forman
Michele R
MR
Eng-Wong
Jennifer
J
Zujewski
JoAnne
J
Stratton
Pamela
P
D000328:Adult; D001943:Breast Neoplasms / Q000209:etiology / Q000517:prevention & control*; D002119:Calcium Carbonate / Q000008:administration & dosage; D002277:Carcinoma / Q000209:etiology / Q000517:prevention & control*; D019314:Dehydroepiandrosterone Sulfate / Q000097:blood; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005836:Genitalia, Female / Q000000981:diagnostic imaging / Q000187:drug effects*; D012739:Gonadal Steroid Hormones / Q000097:blood*; D006801:Humans; D008597:Menstrual Cycle / Q000097:blood; D008875:Middle Aged; D011127:Polyps / Q000139:chemically induced / Q000000981:diagnostic imaging; D017697:Premenopause / Q000187:drug effects*; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012307:Risk Factors; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D014463:Ultrasonography; D014591:Uterine Diseases / Q000139:chemically induced / Q000000981:diagnostic imaging
D012739:Gonadal Steroid Hormones; D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride; D019314:Dehydroepiandrosterone Sulfate; D002119:Calcium Carbonate