- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06107166
Testosterone and Vascular Function in Reproductive-Aged Females With Chronic Kidney Disease
October 24, 2023 updated by: Sandra Dumanski, University of Calgary
Cardiovascular disease (CVD) is the leading cause of death among women and women with chronic kidney disease are at an even greater risk of CVD.
The aim of this observational study is to examine the relationship between total testosterone levels and measures of vascular function (pulse wave velocity, aortic augmentation index, flow mediated dilation and velocity time integral) in reproductive-aged women living with chronic kidney disease.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
61
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
-
-
Alberta
-
Calgary, Alberta, Canada, T2N1N4
- University of Calgary
-
-
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
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population will include stable females of reproductive age (18-51 years of age) with chronic kidney disease.
Subjects will require permission of their primary nephrologist or primary care provider to participate
Description
Inclusion Criteria:
- female sex
- a diagnosis of chronic kidney disease or end stage kidney disease
- age 18-51
Exclusion Criteria:
Pregnancy, breastfeeding, current use of menopausal hormone therapy or gender affirming hormone therapy, or factors that would affect ovarian function, such as polycystic ovarian syndrome, premature ovarian insufficiency, ovarian malignancy, gonadotoxic chemotherapy, surgical oophorectomy, or previous radiation to the pelvis.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pulse wave velocity
Time Frame: Measured at baseline
|
Measured at baseline
|
Aortic augmentation index
Time Frame: Measured at baseline
|
Measured at baseline
|
Flow mediated dilation
Time Frame: Measured at baseline
|
Measured at baseline
|
Velocity time integral
Time Frame: Measured at baseline
|
Measured at baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
June 1, 2018
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
October 24, 2023
First Submitted That Met QC Criteria
October 24, 2023
First Posted (Actual)
October 30, 2023
Study Record Updates
Last Update Posted (Actual)
October 30, 2023
Last Update Submitted That Met QC Criteria
October 24, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB18-0642
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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