Examining the Long-Term Risks of Oophorectomy

This study has been completed.
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by:
Parker, William H., M.D.
ClinicalTrials.gov Identifier:
NCT00655447
First received: April 3, 2008
Last updated: April 8, 2008
Last verified: April 2008
  Purpose

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.


Condition
Coronary Heart Disease
Stroke
Breast Cancer
Ovarian Cancer
Cancer
Hip Fracture
Death

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ovarian Conservation: Long-Term Health Outcomes From the Nurse's Health Study.

Resource links provided by NLM:


Further study details as provided by Parker, William H., M.D.:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 32175
Study Start Date: January 1980
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
all women having a hysterectomy with oophorectomy
2
all women having a hysterectomy without removal of ovaries

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.

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Nurses' Health Study I, which included 122,701 married registered nurses living in 11 U.S. states and who were ages 30 to 55 in 1976

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00655447

Locations
United States, California
Parker, Rosenman, Rodi Gynecology Group
Santa Monica, California, United States, 90401
Sponsors and Collaborators
Parker, William H., M.D.
Ethicon, Inc.
Investigators
Principal Investigator: William H Parker, MD John Wayne Cancer Institute
  More Information

Publications:
Responsible Party: William Parker, John Wayne Cancer Institute
ClinicalTrials.gov Identifier: NCT00655447     History of Changes
Other Study ID Numbers: PARW-OVCONS-0307
Study First Received: April 3, 2008
Last Updated: April 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Parker, William H., M.D.:
oophorectomy
ovarian conservation
stroke
breast cancer
ovarian cancer
other cancer
hip fracture

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ovarian Neoplasms
Hip Fractures
Breast Neoplasms
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014