Effects of Raloxifene on the Uterus and Ovaries of Premenopausal Patients

NCT00001837 | Completed

• 2 other identifiers: 99001399-CC-0013
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer; Breast Neoplasm

Keywords

Sonohysterography; Color Doppler Sonography; Endometrium; Gynecologic; Menstrual Cycle; Premenopause

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Women must be enrolled in NCI Study 98-C-0123.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 9747868 BACKGROUND

• 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.

  PMID: 8181578 BACKGROUND

• 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.

  PMID: 1592278 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: November 1, 1998
• Study Completion: October 1, 2005
• Last Updated: March 4, 2008

Record last verified: 2005-10

Locations

US (1)