Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001837
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Effects of Raloxifene on the Uterus and Ovaries of Premenopausal Patients
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Sonographic Evaluation of the Effects of Raloxifene on the Uterus and Ovaries in Premenopausal Patients at High Risk for Developing Breast Cancer
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-CC-0013 | None | None | None |