Examining the Long-Term Risks of Oophorectomy

Official Title: “Ovarian Conservation: Long-Term Health Outcomes From the Nurse's Health Study.”

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.

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.

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • all women having a hysterectomy with oophorectomy
• : 2
  • all women having a hysterectomy without removal of ovaries

Primary Measures

• 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.
  • Time Frame: 28 years
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: 28 years
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Parker, William H., M.D. Other

Overall Clinical Trial Officials and Contacts

William H Parker, MD Principal Investigator John Wayne Cancer Institute  

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00655447

Study ID Number: PARW-OVCONS-0307

ClinicalTrials.gov Identifier: NCT00655447

Health Authority: United States: Institutional Review Board