Examining the Long-Term Risks of Oophorectomy

Completed

• Conditions: Coronary Heart Disease; Stroke; Breast Cancer; Ovarian Cancer; Cancer; Hip Fracture; Death

• Registration Number: NCT00655447
• Lead Sponsor: Parker, William H., M.D.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 1980-01
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Status Verified: 2008-04
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-08
• Last Update Submitted: 2008-04-08
• Study First Posted: 2008-04-09
• Last Update Posted: 2008-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32175

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Parker, Rosenman, Rodi Gynecology Group; 🇺🇸 Santa Monica, California, United States