Short-term urogenital effects of raloxifene, tamoxifen, and estrogen.
OBJECTIVE
The purpose of this study was to assess the urogenital effects of raloxifene, tamoxifen, conjugated equine estrogen, and placebo in healthy postmenopausal women.


METHODS
This randomized, double-blind, placebo-controlled study compared the urogenital effects of 0.625 mg of conjugated equine estrogen (n = 15 women), 20 mg of tamoxifen (n = 14 women), 60 mg of raloxifene, (n = 15 women), and placebo (n = 13 women). Evaluations at baseline and evaluations after 20 weeks receiving the drug included a pelvic examination with cytologic evaluation of vagina and urethra, pelvic organ prolapse quantitation, and urethral axis deflection by cotton swab test (only in patients with incontinence [33%]).


RESULTS
Conjugated equine estrogen increased the maturation value of both urethral and vaginal cytologic condition (P =.002, P =.032, respectively). There was a decrease in vaginal maturation value in the raloxifene group (not significant). Two of 8 women in the conjugated equine estrogen group showed evidence of worsening prolapse by pelvic organ prolapse quantitation; the condition of 2 of 8 women improved. In the raloxifene, tamoxifen, and placebo groups 8 of 12 women, 4 of 13 women, and 2 of 11 women had worsening in prolapse scores, respectively, whereas none of the women had improvement. Increased cotton swab deflection was found in 3 of 5 women in the raloxifene group, in 5 of 8 women in the tamoxifen group, in 0 of 4 women in the placebo group, and in 0 of 2 women in the conjugated equine estrogen group. Seventy-five percent of the patients who received raloxifene and 60% of the patients who received tamoxifen had increases in prolapse by any measure (ie, pelvic organ prolapse quantitation or cotton swab or clinical assessment) compared with 18% of the patients in the placebo group and 22% of the patients in the conjugated equine estrogen group (P =.015), although symptoms did not differ among groups.


CONCLUSIONS
Neither raloxifene nor tamoxifen improve cytohormonal effects in the vagina or urethra, whereas conjugated equine estrogen does. Raloxifene and tamoxifen appear to show worsening prolapse compared with conjugated equine estrogen and placebo. The clinical relevance of these effects is unknown and requires investigation.
Vardy
Michael D
MD
Department of Obstetrics and Gynecology and Women's Health, Albert Einstein College of Medicine, USA. urogyn1@cs.com
Lindsay
Robert
R
Scotti
Richard J
RJ
Mikhail
Magdy
M
Richart
Ralph M
RM
Nieves
Jeri
J
Zion
Marsha
M
Cosman
Felicia
F
D000368:Aged; D001284:Atrophy; D004311:Double-Blind Method; D004958:Estradiol / Q000097:blood; D004967:Estrogens / Q000009:adverse effects* / Q000627:therapeutic use; D004966:Estrogens, Conjugated (USP) / Q000009:adverse effects / Q000627:therapeutic use; D004970:Estrone / Q000097:blood; D005260:Female; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D010919:Placebos; D020849:Raloxifene Hydrochloride / Q000009:adverse effects* / Q000627:therapeutic use; D013629:Tamoxifen / Q000009:adverse effects* / Q000627:therapeutic use; D014521:Urethra / Q000187:drug effects / Q000473:pathology; D014596:Uterine Prolapse / Q000139:chemically induced; D014621:Vagina / Q000187:drug effects / Q000473:pathology
D004967:Estrogens; D004966:Estrogens, Conjugated (USP); D010919:Placebos; D013629:Tamoxifen; D004970:Estrone; D020849:Raloxifene Hydrochloride; D004958:Estradiol