Coronary Heart DiseaseNCT00655447
Examining the Long-Term Risks of Oophorectomy
An observational study of Coronary Heart Disease and Stroke, run by Parker, William H., M.D. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Stroke, Breast Cancer
- How many people
- 32,175 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1980to Jun 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Women who had hysterectomies were classified into simple hysterectomy or hysterectomy with both ovaries removed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Parker, Rosenman, Rodi Gynecology Group
Santa Monica, California, 90401
About this study
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.
Read the 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.
- Conditions
- Coronary Heart Disease, Stroke, Breast Cancer, Ovarian Cancer, Cancer, Hip Fracture
- Keywords
- oophorectomy, ovarian conservation, stroke, breast cancer, ovarian cancer, other cancer, hip fracture
- Medical subject headings
- Coronary Disease, Stroke, Breast Neoplasms, Ovarian Neoplasms, Neoplasms, Hip Fractures, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | all women having a hysterectomy with oophorectomy | |
| 2 | all women having a hysterectomy without removal of ovaries |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 years
Secondary outcomes (1)
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.
Measured: 28 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startJan 1980
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32,175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker, William H., M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc.
- Investigators
- William H Parker, MD, Principal investigator, Saint John's Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655447
- Sponsor's protocol ID
- PARW-OVCONS-0307
- Status last verified
- Apr 2008
- First submitted
- 3 Apr 2008
- Last updated
- 9 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1097/01.AOG.0000167394.38215.56.
PubMed 16055568
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Conservation: Long-Term Health Outcomes From the Nurse's Health Study.
- ClinicalTrials.gov ID
- NCT00655447
- Acronym / sponsor ID
- PARW-OVCONS-0307
- Conditions
- Coronary Heart Disease, Stroke, Breast Cancer, Ovarian Cancer, Cancer, Hip Fracture
- Keywords
- oophorectomy, ovarian conservation, stroke, breast cancer, ovarian cancer, other cancer, hip fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32,175 participants (actual)
- Lead sponsor
- Parker, William H., M.D.University, hospital or other
- Collaborators
- Ethicon, Inc.
- Study start
- Jan 1980
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 9 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –all women having a hysterectomy with oophorectomy |
| 2 | – | –all women having a hysterectomy without removal of ovaries |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- Women who had hysterectomies were classified into simple hysterectomy or hysterectomy with both ovaries removed.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2008.
- Background: PubMed 16055568Parker 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. doi: 10.1097/01.AOG.0000167394.38215.56.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William H Parker, MD principal investigator
Saint John's Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease and Stroke, run by Parker, William H., M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00655447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2008.