Endometrial CancerNCT00543192
Sexual Functioning in Endometrial Cancer
An observational study of Endometrial Cancer and Sexual Function, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is estimate how sexual function in endometrial cancer survivors varies with severity of disease. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Sexual Function
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jun 2009
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: University of Wisconsin Gynecologic Oncology and Radiation Oncology Clinics
Who may be able to join
- History of Stage I-IIIA endometrial adenocarcinoma of any grade
- 1-5 years out from primary surgical treatment
- Adjuvant therapy may only have consisted of radiation or hormonal therapy
- No evidence of disease
Who cannot join
- Previous treatment for other malignancies
- Did not undergo surgery for primary treatment of endometrial cancer
- Inability to read, write and speak fluent English
- Major cognitive impairment affecting ability to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Official title: Sexual Functioning in Endometrial Cancer Survivors
The purpose of this study is estimate how sexual function in endometrial cancer survivors varies with severity of disease.
- Conditions
- Endometrial Cancer, Sexual Function
- Keywords
- Endometrial Cancer, Sexual Function
- Medical subject headings
- Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index (FSFI).
Measured: at time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2009
- Study completionJun 2009
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 Endometrial CancerStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David M Kushner, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543192
- Sponsor's protocol ID
- CC07703
- Other IDs
- H-2007-0204, A532820, SMPH/OBSTET & GYNECOL
- Status last verified
- Sep 2009
- First submitted
- 10 Oct 2007
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Onujiogu N, Johnson T, Seo S, Mijal K, Rash J, Seaborne L, Rose S, Kushner DM. Survivors of endometrial cancer: who is at risk for sexual dysfunction? Gynecol Oncol. 2011 Nov;123(2):356-9. doi: 10.1016/j.ygyno.2011.07.035.
PubMed 21855974
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Functioning in Endometrial Cancer Survivors
- ClinicalTrials.gov ID
- NCT00543192
- Acronym / sponsor ID
- CC07703
- Conditions
- Endometrial Cancer, Sexual Function
- Keywords
- Endometrial Cancer, Sexual Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 12 Oct 2007 (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.
The purpose of this study is estimate how sexual function in endometrial cancer survivors varies with severity of disease.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University of Wisconsin Gynecologic Oncology and Radiation Oncology Clinics
Key inclusion criteria (4 listed)
- History of Stage I-IIIA endometrial adenocarcinoma of any grade
- 1-5 years out from primary surgical treatment
- Adjuvant therapy may only have consisted of radiation or hormonal therapy
- No evidence of disease
Key exclusion criteria (4 listed)
- Previous treatment for other malignancies
- Did not undergo surgery for primary treatment of endometrial cancer
- Inability to read, write and speak fluent English
- Major cognitive impairment affecting ability to provide consent
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
Female Sexual Function Index (FSFI).
Time frame: at time of enrollment
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 19 Nov 2019.
- Results publication: PubMed 21855974Onujiogu N, Johnson T, Seo S, Mijal K, Rash J, Seaborne L, Rose S, Kushner DM. Survivors of endometrial cancer: who is at risk for sexual dysfunction? Gynecol Oncol. 2011 Nov;123(2):356-9. doi: 10.1016/j.ygyno.2011.07.035.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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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.
David M Kushner, MD principal investigator
University of Wisconsin, Madison
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 Endometrial Cancer and Sexual Function, run by University of Wisconsin, Madison 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 4 inclusion and 4 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 19 Nov 2019. 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?
Female Sexual Function Index (FSFI). (time frame: at time of enrollment). 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 NCT00543192, 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 19 Nov 2019.