Hormone TherapyNCT05442463
Hormone Therapy and Angiotensin-Dependent Arterial and Renal Vasoconstriction in Humans
An observational study of Hormone Therapy, run by University of Calgary at 1 site in Canada.
Trial summary
1. to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women. 2. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hormone Therapy
- What is being tested?
- Captopril Tablets and Iohexol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2020to 30 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult ages 18 - 90 years cisgender (gender identity that aligns with sex at birth) and transgender (gender identity that does not align with sex at birth) adult women and men who are on oral, non-oral or no hormone therapy.
Who may be able to join
- Age 18 to 90 years
- Taking hormones orally or non-orally (either estrogen, progesterone or testosterone)
Who cannot join
- Cardiovascular disease (symptoms consistent with myocardial ischemia, previously documented myocardial ischemia, cardiac arrhythmias or valve abnormalities, or abnormal ECG at screening)
- Cerebrovascular disease (transient ischemic attacks or stroke)
- History of hypertension (BP>140/90 or use of antihypertensive medications)
- Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2
- Diabetes mellitus (defined by history, use of hypoglycaemic agents or a fasting glucose >7mmol/L)
- Current smoker
- Previous history of preeclampsia
- Anabolic steroids, cortical steroids, or non-steroidal anti-inflammatory medications, or at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 4Z6
Darlene Y Sola, BScN, 4036149431, dsola@ucalgary.ca
Victoria Riehl-Tonn, BN, 4036149431, victoria.riehltonn@ucalgary.ca
About this study
Official title: Hormone Therapy and Angiotensin-Dependent Arterial and Renal
- to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women.
- to investigate the association between exogenous testosterone exposure and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) men.
Read the detailed description
Participants are screened for eligibility.
Study involves a 4.5 hour morning in the lab:
- Participants come fasting
- IV infusion and blood draws
- Non invasive testing - Holter monitor, sphygmocor, bioelectrical impedance, blood pressure checks
- Conditions
- Hormone Therapy
- Being tested
- Captopril Tablets, Iohexol
- Keywords
- post menopausal hormone replacement therapy, transgender men, transgender women, nonbinary, cis gender, post menopause, HRT, hormone replacement therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Captopril TabletsDrug
Also called Capoten
Captorpril challenge to each participant
IohexolDrug
Also called Omnipaque
Iohexol infusion to evaluate measured GFR
| Study group | Role | What they receive |
|---|---|---|
| Cisgender and transgender women | Iohexol 5 ml IV push followed 10 ml IV flush of normal saline is administered to establish baseline GFR (glomerular filtration rate). FF (filtration fraction) is calculated as follows: GFR/RPF=FF. Captopril 25 mg is given orally.
Blood will be collected at specific time points, pulse wave velocity testing 3 times throughout morning, Holter monitor and bioelectrical impedance testing. Receives: Drug: Captopril Tablets; Drug: Iohexol | |
| Cisgender and transgender men | Iohexol 5 ml IV push followed 10 ml IV flush of normal saline is administered to establish baseline GFR (glomerular filtration rate). FF (filtration fraction) is calculated as follows: GFR/RPF=FF. Captopril 25 mg is given orally.
Blood will be collected at specific time points, pulse wave velocity testing 3 times throughout morning, Holter monitor and bioelectrical impedance testing. Receives: Drug: Captopril Tablets; Drug: Iohexol |
What is being measured
The primary outcome is the main question the study is designed to answer.
First association in transgender women and cis women
to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women.
Measured: 2025
Second association in transgender men and cis men
to investigate the association between exogenous testosterone exposure and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) men.
Measured: 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start30 Nov 2020
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone TherapyStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Ahmed, University of Calgary
- Investigators
- Sofia Ahmed, MD, Principal investigator, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442463
- Sponsor's protocol ID
- REB19-0460
- Status last verified
- Mar 2025
- First submitted
- 28 Jun 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormone Therapy and Angiotensin-Dependent Arterial and Renal
- ClinicalTrials.gov ID
- NCT05442463
- Acronym / sponsor ID
- REB19-0460
- Conditions
- Hormone Therapy
- Keywords
- post menopausal hormone replacement therapy, transgender men, transgender women, nonbinary, cis gender, post menopause, HRT, hormone replacement therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 5 Jul 2022 (actual)
- 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.
- to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women.
- to investigate the association between exogenous testosterone exposure and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) men.
Detailed description
Participants are screened for eligibility.
Study involves a 4.5 hour morning in the lab:
- Participants come fasting
- IV infusion and blood draws
- Non invasive testing - Holter monitor, sphygmocor, bioelectrical impedance, blood pressure checks
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cisgender and transgender women | – | Drug: Captopril Tablets, Drug: IohexolIohexol 5 ml IV push followed 10 ml IV flush of normal saline is administered to establish baseline GFR (glomerular filtration rate). FF (filtration fraction) is calculated as follows: GFR/RPF=FF. Captopril 25 mg is given orally. Blood will be collected at specific time points, pulse wave velocity testing 3 times throughout morning, Holter monitor and bioelectrical impedance testing. |
| Cisgender and transgender men | – | Drug: Captopril Tablets, Drug: IohexolIohexol 5 ml IV push followed 10 ml IV flush of normal saline is administered to establish baseline GFR (glomerular filtration rate). FF (filtration fraction) is calculated as follows: GFR/RPF=FF. Captopril 25 mg is given orally. Blood will be collected at specific time points, pulse wave velocity testing 3 times throughout morning, Holter monitor and bioelectrical impedance testing. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult ages 18 - 90 years cisgender (gender identity that aligns with sex at birth) and transgender (gender identity that does not align with sex at birth) adult women and men who are on oral, non-oral or no hormone therapy.
Key inclusion criteria (2 listed)
- Age 18 to 90 years
- Taking hormones orally or non-orally (either estrogen, progesterone or testosterone)
Key exclusion criteria (8 listed)
- Cardiovascular disease (symptoms consistent with myocardial ischemia, previously documented myocardial ischemia, cardiac arrhythmias or valve abnormalities, or abnormal ECG at screening)
- Cerebrovascular disease (transient ischemic attacks or stroke)
- History of hypertension (BP>140/90 or use of antihypertensive medications)
- Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2
- Diabetes mellitus (defined by history, use of hypoglycaemic agents or a fasting glucose >7mmol/L)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Captopril TabletsAlso: CapotenCaptorpril challenge to each participant | Drug | Cisgender and transgender men, Cisgender and transgender women |
| IohexolAlso: OmnipaqueIohexol infusion to evaluate measured GFR | Drug | Cisgender and transgender men, Cisgender and transgender women |
Primary outcome
First association in transgender women and cis women
Time frame: 2025
to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women.
Second association in transgender men and cis men
Time frame: 2025
to investigate the association between exogenous testosterone exposure and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) men.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Sofia Ahmed, MD principal investigator
Alberta Health services
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 Hormone Therapy, run by University of Calgary at 1 site in Canada.
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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 Mar 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darlene Y Sola, BScN (4032107434, dsola@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First association in transgender women and cis women (time frame: 2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2025.