Effects of Raloxifene on the Uterus and Ovaries of Premenopausal Patients
Primary Purpose
Breast Cancer, Breast Neoplasm
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Breast Cancer focused on measuring Sonohysterography, Color Doppler Sonography, Endometrium, Gynecologic, Menstrual Cycle, Premenopause
Eligibility Criteria
Women must be enrolled in NCI Study 98-C-0123.
Sites / Locations
- National Institutes of Health Clinical Center (CC)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001837
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institutes of Health Clinical Center (CC)
1. Study Identification
Unique Protocol Identification Number
NCT00001837
Brief Title
Effects of Raloxifene on the Uterus and Ovaries of Premenopausal Patients
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 Type
Observational
2. Study Status
Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
November 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institutes of Health Clinical Center (CC)
4. Oversight
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasm
Keywords
Sonohysterography, Color Doppler Sonography, Endometrium, Gynecologic, Menstrual Cycle, Premenopause
7. Study Design
Enrollment
60 (false)
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Women must be enrolled in NCI Study 98-C-0123.
Facility Information:
Facility Name
National Institutes of Health Clinical Center (CC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9747868
Citation
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. doi: 10.1093/jnci/90.18.1371.
Results Reference
background
PubMed Identifier
8181578
Citation
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.
Results Reference
background
PubMed Identifier
1592278
Citation
Wolf DM, Jordan VC. Gynecologic complications associated with long-term adjuvant tamoxifen therapy for breast cancer. Gynecol Oncol. 1992 May;45(2):118-28. doi: 10.1016/0090-8258(92)90273-l.
Results Reference
background
Learn more about this trial
Effects of Raloxifene on the Uterus and Ovaries of Premenopausal Patients
We'll reach out to this number within 24 hrs