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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06107166
Other study ID # REB18-0642
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date December 31, 2021

Study information

Verified date October 2023
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date December 31, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 51 Years
Eligibility 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 Design


Locations

Country Name City State
Canada University of Calgary Calgary Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pulse wave velocity Measured at baseline
Primary Aortic augmentation index Measured at baseline
Primary Flow mediated dilation Measured at baseline
Primary Velocity time integral Measured at baseline
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