Examining the Long-Term Risks of Oophorectomy

Breast Cancer Clinical Trial

Official title:

Ovarian Conservation: Long-Term Health Outcomes From the Nurse's Health Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655447
• Other study ID #: PARW-OVCONS-0307
• Status: Completed
• Phase: N/A
• First received: April 3, 2008
• Last updated: April 8, 2008
• Start date: January 1980
• Est. completion date: June 2004

Study information

• Verified date: April 2008
• Source: Parker, William H., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

At the time of hysterectomy for benign disease, the overall health benefits of preserving ovarian function in a large population of women have not been established.

Description:

We are conducting a prospective, observational study of 32,175 women participants of the Nurse's Health Study who had a hysterectomy with or without removal of both ovaries. We are evaluating mortality and morbidity due to the following conditions: coronary heart disease, stroke, breast cancer, ovarian cancer, other cancer, hip fracture and death from all causes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32175
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 55 Years

Eligibility

Inclusion Criteria:

• Women who had hysterectomies were classified into simple hysterectomy or hysterectomy with both ovaries removed.

Exclusion Criteria:

• Evidence of cancer, coronary heart disease (MI or Angina Pectoris), stroke, or hip fracture before entering the study were excluded. Cancer as an indication for hysterectomy also excluded.

• Women reporting unilateral oophorectomy, unknown oophorectomy status, unknown age of hysterectomy, or those who had oophorectomy before hysterectomy were excluded.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Cancer
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Death
• Hip Fracture
• Hip Fractures
• Myocardial Ischemia
• Ovarian Cancer
• Ovarian Neoplasms
• Stroke

Locations

Country	Name	City	State
United States	Parker, Rosenman, Rodi Gynecology Group	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Parker, William H., M.D.	Ethicon, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Parker WH, Broder MS, Liu Z, Shoupe D, Farquhar C, Berek JS. Ovarian conservation at the time of hysterectomy for benign disease. Obstet Gynecol. 2005 Aug;106(2):219-26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality and morbidity due to the following conditions: coronary heart disease, stroke, breast cancer, ovarian cancer, other cancer, hip fracture and death from all causes.		28 years	No
Secondary	The effect of postmenopausal hormone use on mortality and morbidity due to the following conditions: coronary heart disease, stroke, breast cancer, ovarian cancer, other cancer, hip fracture and death from all causes.		28 years	No