Sexual Functioning in Endometrial Cancer | NCT00543192

Studies
Sexual Functioning in Endometrial Cancer

NCT00543192

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Nov 19, 2019Actual

Enrollment

73Actual

Phase

Not provided

Conditions

Endometrial Cancer
Sexual Function

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
H-2007-0204	Other Identifier	Institutional Review Board
A532820	Other Identifier	UW Madison
SMPH/OBSTET & GYNECOL	Other Identifier	UW Madison

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Oct 10, 2007

First Submission Date that Met QC Criteria

Oct 10, 2007

First Posted Date

Oct 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2019

Last Update Posted Date

Nov 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is estimate how sexual function in endometrial cancer survivors varies with severity of disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

73Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Female Sexual Function Index (FSFI).		at time of enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

University of Wisconsin Gynecologic Oncology and Radiation Oncology Clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David M Kushner, MD	University of Wisconsin, Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin School of Medicine and Public Health		Madison	Wisconsin	53792	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21855974	Result	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.

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site