Effects of Raloxifene on the Uterus and Ovaries of Premenopausal Patients
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Breast Neoplasm
Phase: N/A
Status: Completed
Sponsored by: National Institutes of Health Clinical Center (CC)
Summary
This research study is designed to work in cooperation with another study being conducted by
the National Cancer Institute. The National Cancer Institute (NCI) is studying the effects
of a drug called raloxifene on premenopausal women believed to have a high risk of developing
breast cancer (98-C-0123).
In this study, researchers are interested in learning about the effects of raloxifene on the
uterus and ovaries of the women participating in the NCI study. To do this researchers plan
to conduct ultrasounds on the patients enrolled in the NCI study. In addition researchers
plan to take samples of the lining of the uterus in these patients (endometrial biopsy) if
found to be necessary.
The purpose of this study is to determine the reproductive effects of raloxifene on women who
have normal functioning ovaries by taking ultrasounds of the ovaries and lining of the uterus
(endometrium).
Clinical Details
Official title: Sonographic Evaluation of the Effects of Raloxifene on the Uterus and Ovaries in Premenopausal Patients at High Risk for Developing Breast Cancer
Study design: N/A
Detailed description:
Raloxifene is a selective estrogen receptor-modulating agent that has been recently approved
by the FDA for the treatment of osteoporosis in postmenopausal patients. A phase II trial
evaluating the safety and efficacy of raloxifene in premenopausal patients at high risk for
developing breast cancer has been recently approved by the IRB (98-C-0123). In this
protocol, for assessment of the effects of raloxifene on the endometrium and ovaries,
patients are scheduled to be studied with transvaginal sonography and hysterosonography, once
during their menstrual cycle at periodic intervals. They are also scheduled to have
endometrial biopsies as indicated. It is known that all SERMs (clomiphene, tamoxifen and in
one small study raloxifene) raise the area under the curve of estradiol levels throughout the
cycle in premenopausal women. Our study is designed to study the reproductive effects of
raloxifene in these young women with competent ovaries using sonography of the ovaries and
endometrium, and correlating it with steroid hormone levels which would be obtained under
protocol 98-C-0123.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Women must be enrolled in NCI Study 98-C-0123.
Locations and Contacts
National Institutes of Health Clinical Center (CC), Bethesda, Maryland 20892, United States
Additional Information
Related publications: Fisher B, Costantino JP, Wickerham DL, Redmond CK, Kavanah M, Cronin WM, Vogel V, Robidoux A, Dimitrov N, Atkins J, Daly M, Wieand S, Tan-Chiu E, Ford L, Wolmark N. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst. 1998 Sep 16;90(18):1371-88. Rayter Z, Gazet JC, Shepherd J, Trott PA, Fisher C, Svensson WE, Ford HT, A'Hern R. Gynaecological cytology and pelvic ultrasonography in patients with breast cancer taking tamoxifen compared with controls. Eur J Surg Oncol. 1994 Apr;20(2):134-40. Wolf DM, Jordan VC. Gynecologic complications associated with long-term adjuvant tamoxifen therapy for breast cancer. Gynecol Oncol. 1992 May;45(2):118-28. Review.
Starting date: November 1998
Ending date: October 2005
Last updated: March 3, 2008
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