A 12-month comparative study of raloxifene, estrogen, and placebo on the postmenopausal endometrium

Obstetrics and Gynecology

Volumn 95, Issue 1, 2000, Pages 95-103

  Goldstein, Steven R ^a,c,d   Scheele, Wim H ^b,c,d   Rajagopalan, Srikanth K ^b,c,d   Wilkie, Jennifer L ^b,c,d   Walsh, Brian W ^a,b,c,d   Parsons, Anna K ^a,b,c,d  

^a NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b ELI LILLY AND COMPANY   (United States)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

^d UNIVERSITY OF SOUTH FLORIDA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONJUGATED ESTROGEN; PLACEBO; RALOXIFENE;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; ENDOMETRIUM HYPERPLASIA; FEMALE; HUMAN; HUMAN TISSUE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; POSTMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TRANSVAGINAL ECHOGRAPHY;

ADULT; DOUBLE-BLIND METHOD; ENDOMETRIUM; ESTRADIOL CONGENERS; FEMALE; HUMANS; MIDDLE AGED; RALOXIFENE; SELECTIVE ESTROGEN RECEPTOR MODULATORS;

EID: 0033989921     PISSN: 00297844     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0029-7844(99)00502-5     Document Type: Article

References (34)

1. Khovidhunkit W., Shoback D.M. Clinical effects of raloxifene hydrochloride in women. Ann Intern Med. 130:1999;431-439.
2. Delmas P.D., Bjarnason N.H., Mitlak B.H., Ravoux A.C., Shah A.S., Huster W.J., et al. Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women. N Engl J Med. 337:1997;1641-1647.
3. Cummings S., Eckert S., Krueger K., Grady D., Powles T., Cauley J., et al. The effect of raloxifene on risk of breast cancer in postmenopausal women. JAMA. 281:1999;2189-2197.
4. Walsh B.W., Kuller L.H., Wild R.A., Paul S., Farmer M., Lawrence J.B., et al. Effects of raloxifene on serum lipids and coagulation factors in healthy postmenopausal women. JAMA. 279:1998;1445-1451.
5. Tamoxifen for early breast cancer An overview of the randomised trials . Lancet. 351:1998;1451-1467.
6. Fisher B., Costantino J.P., Wickerham D.L., Redmond C.K., Kavanah M., Cronin W.M., et al. Tamoxifen for prevention of breast cancer Report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study . J Natl Cancer Inst. 90:1998;1371-1388.
7. Killackey M.A., Hakes T.B., Pierce V.K. Endometrial adenocarcinoma in breast cancer patients receiving antiestrogens. Cancer Treat Rep. 69:1985;237-238.
8. Fisher B., Costantino J.P., Redmond C.K., Fisher E.R., Wickerham D.L., Cronin W.M. Endometrial cancer in tamoxifen-treated breast cancer patients Findings from the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-14 . J Natl Cancer Inst. 86:1994;527-537.
9. Barakat R.R. Tamoxifen and the endometrium. Cancer Treat Res. 94:1998;195-207.
10. Kedar R.P., Bourne T.H., Powles T.J., Collins W.P., Ashley S.E., Cosgrove D.O., et al. Effects of tamoxifen on uterus and ovaries of postmenopausal women in a randomised breast cancer prevention trial. Lancet. 343:1994;1318-1321.
11. Tomas E., Kauppila A., Blanco G., Apaja-Sarkkinen M., Laatikainen T. Comparison between the effects of tamoxifen and toremifene on the uterus in postmenopausal breast cancer patients. Gynecol Oncol. 59:1995;261-266.
12. Effects of hormone replacement therapy on endometrial histology in postmenopausal women. The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. The Writing Group for the PEPI Trial. JAMA. 275:1996;370-375.
13. Ziel H.K., Finkle W.D. Increased risk of endometrial carcinoma among users of conjugated estrogens. N Engl J Med. 293:1975;1167-1170.
14. Mack T.M., Pike M.C., Henderson B.E., Pfeffer R.I., Gerkins V.R., Arthur M., et al. Estrogens and endometrial cancer in a retirement community. N Engl J Med. 294:1976;1262-1267.
15. Smith D.C., Prentice R., Thompson D.J., Herrmann W.L. Association of exogenous estrogen and endometrial carcinoma. N Engl J Med. 293:1975;1164-1167.
16. Beresford S.A., Weiss N.S., Voigt L.F., McKnight B.S. Risk of endometrial cancer in relation to use of oestrogen combined with cyclic progestagen therapy in postmenopausal women. Lancet. 349:1997;458-461.
17. Woodruff J.D., Pickar J.H. Incidence of endometrial hyperplasia in postmenopausal women taking conjugated estrogens (Premarin) with medroxyprogesterone acetate or conjugated estrogens alone. The Menopause Study Group. Am J Obstet Gynecol. 170:1994;1213-1223.
18. Lindsay R., Hart D.M., Clark D.M. The minimum effective dose of estrogen for prevention of postmenopausal bone loss. Obstet Gynecol. 63:1984;759-763.
19. Ettinger B., Genant H.K., Cann C.E. Long-term estrogen replacement therapy prevents bone loss and fractures. Ann Intern Med. 102:1985;319-324.
20. Guidance for clinical evaluation of combination estrogen/progestin-containing drug products used for hormone replacement therapy in postmenopausal women. Menopause. 2:1995;131-136.
21. Parsons A.K., Lense J.J. Sonohysterography for endometrial abnormalities Preliminary results . J Clin Ultrasound. 21:1993;87-95.
22. Goldstein S.R. Unusual ultrasonographic appearance of the uterus in patients receiving tamoxifen. Am J Obstet Gynecol. 170:1994;447-451.
23. Schwartz L.B., Snyder J., Horan C., Porges R.F., Nachtigall L.E., Goldstein S.R. The use of transvaginal ultrasound and saline infusion sonohysterography for the evaluation of asymptomatic postmenopausal breast cancer patients on tamoxifen. Ultrasound Obstet Gynecol. 11:1998;48-53.
24. Kurman R.J., Norris H.J. Endometrial hyperplasia and related cellular changes. Kurman R.J. Blaustein's pathology of the female genital tract. 4th ed. 1994;411-427 Springer-Verlag, New York.
25. Goldstein S.R., Timor-Tritsch I.E. Ultrasound in gynecology. 1995;Churchill Livingstone, Inc, New York.
26. Parsons A., Hill A., Spicer D. Sonohysterographic imaging of the endometrial cavity. Frontiers Biosci. 1:1996;1-5.
27. Boss S.M., Huster W.J., Neild J.A., Glant M.D., Eisenhut C.C., Draper M.W. Effects of raloxifene hydrochloride on the endometrium of postmenopausal women. Am J Obstet Gynecol. 177:1997;1458-1464.
28. Notelovitz M., Varner R.E., Rebar R.W., Fleischmann R., McIlwain H.H., Schwartz S.L., et al. Minimal endometrial proliferation over a two-year period in postmenopausal women taking 0.3 mg of unopposed esterified estrogens. Menopause. 4:1997;80-88.
29. Neven P., De Muylder X., Van Belle Y., Campo R., Vanderick G. Tamoxifen and the uterus Women given this drug need careful assessment . BMJ. 309:1994;1313-1314.
30. Fisher B., Dignam J., Bryant J., DeCillis A., Wickerham D.L., Wolmark N., et al. Five versus more than five years of tamoxifen therapy for breast cancer patients with negative lymph nodes and estrogen receptor- positive tumors. J Natl Cancer Inst. 88:1996;1529-1542.
31. Assikis V.J., Neven P., Jordan V.C., Vergote I. A realistic clinical perspective of tamoxifen and endometrial carcinogenesis. Eur J Cancer. 32A:1996;1464-1476.
32. Lahti E., Blanco G., Kauppila A., Apaja-Sarkkinen M., Taskinen P.J., Laatikainen T. Endometrial changes in postmenopausal breast cancer patients receiving tamoxifen. Obstet Gynecol. 81:1993;660-664.
33. Fornander T., Rutqvist L.E., Cedermark B., Glas U., Mattsson A., Silfversward C., et al. Adjuvant tamoxifen in early breast cancer Occurrence of new primary cancers . Lancet. 1:1989;117-120.
34. Gal D., Kopel S., Bashevkin M., Lebowicz J., Lev R., Tancer M.L. Oncogenic potential of tamoxifen on endometria of postmenopausal women with breast cancer - Preliminary report. Gynecol Oncol. 42:1991;120-123.