Examining the Long-Term Risks of Oophorectomy

April 8, 2008 updated by: Parker, William H., M.D.

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

32175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90401
        • Parker, Rosenman, Rodi Gynecology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
all women having a hysterectomy with oophorectomy
2
all women having a hysterectomy without removal of ovaries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
28 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
28 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parker, William H., M.D.

Collaborators

Ethicon, Inc.

Investigators

  • Principal Investigator: William H Parker, MD, Saint John's Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1980

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

April 3, 2008

First Submitted That Met QC Criteria

April 8, 2008

First Posted (Estimate)

April 9, 2008

Study Record Updates

Last Update Posted (Estimate)

April 9, 2008

Last Update Submitted That Met QC Criteria

April 8, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PARW-OVCONS-0307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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