HypertensionNCT03451747
The Potential Role of Testosterone on Target Organ Damage in Postmenopausal Hypertensive Women
An observational study of Hypertension, run by LanZhou University.
Trial summary
The incidence of CVD-related deaths is generally higher in women than men. Postmenopausal changes in estrogen/androgen ratio that induce a relative androgen excess have been proposed as important factors in the higher prevalence of hypertension. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Hypertension
- How many people
- 322 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2018to 5 Apr 2018
- 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 45 to 65 years
- All sexes
- Adult, Older adult
Study population: A total of 322 hypertensive patients hospitalized in our department from 2016 to 2017 were enrolled. Included 161 postmenopausal hypertensive women and 161 mached hypertensive men.
Who may be able to join
- Clinical diagnosis of hypertension
- Women are all postmenopausal
- Men are matched with women.
Who cannot join
- Secondary hypertension
- Coronary disease
- Heart failure
- Arterial fibrillation
- Previous myocardial infarction
- Previous stroke
Show all 13Show fewer
- Malignant disease
- Kidney failure
- Liver failure
- Neoplastic disease
- Severe neurological diseases
- Severe metabolic or organic decompensation
- Refuse to sign the informed consent form
About this study
Official title: The Potential Role of Testosterone Between Hypertension and Target Organ Damage in Postmenopausal Hypertensive Women
The incidence of CVD-related deaths is generally higher in women than men. Postmenopausal changes in estrogen/androgen ratio that induce a relative androgen excess have been proposed as important factors in the higher prevalence of hypertension. Therefore, the investigators hypothesize that testosterone has potential role between hypertension and target organ damage in postmenopausal hypertensive women. And the objective is to evaluate the effects of testosterone between hypertension and target organ damage in postmenopausal hypertensive women.
- Conditions
- Hypertension
- Keywords
- hypertension, female
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| postmenopausal hypertensive women | Not described | |
| mached hypertensive men | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative indexes of myocardial remodeling
Cardiac structure (left ventricular mass index in grams for square meter) measurement.
Measured: Baseline
Ambulatory blood pressure monitoring
Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.
Measured: Baseline
The level of testosterone (T)
Blood samples used to analyze the levels of sexual hormones were collected between morning 8:00 and 9:00 after an overnight fast. Testosterone (T) units on nanogram per deciliter.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start10 Mar 2018 (estimated)
- Primary completion5 Apr 2018 (estimated)
- Study completion5 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LanZhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Yu, LanZhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451747
- Sponsor's protocol ID
- LanZhou
- Status last verified
- Jan 2018
- First submitted
- 18 Feb 2018
- Last updated
- 5 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang S, Yu H, Jing C, Liang W, Chen L, Lin Y, Li R, Yu J, Li N. Correlation between ambulatory blood pressure indices and sex hormone imbalance in hypertensive women with different menopausal durations: a cross-sectional study. Eur J Med Res. 2026 Jan 19;31(1):95. doi: 10.1186/s40001-025-03797-5.
PubMed 41555389Li N, Ma R, Wang S, Zhao Y, Wang P, Yang Z, Jin L, Zhang P, Ding H, Bai F, Yu J. The potential role of testosterone in hypertension and target organ damage in hypertensive postmenopausal women. Clin Interv Aging. 2019 Apr 29;14:743-752. doi: 10.2147/CIA.S195498. eCollection 2019.
PubMed 31118595
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Role of Testosterone Between Hypertension and Target Organ Damage in Postmenopausal Hypertensive Women
- ClinicalTrials.gov ID
- NCT03451747
- Acronym / sponsor ID
- LanZhou
- Conditions
- Hypertension
- Keywords
- hypertension, female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- LanZhou UniversityUniversity, hospital or other
- Study start
- 10 Mar 2018 (estimated)
- Primary completion
- 5 Apr 2018 (estimated)
- Study completion
- 5 Apr 2018 (estimated)
- First posted
- 2 Mar 2018 (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.
The incidence of CVD-related deaths is generally higher in women than men. Postmenopausal changes in estrogen/androgen ratio that induce a relative androgen excess have been proposed as important factors in the higher prevalence of hypertension. Therefore, the investigators hypothesize that testosterone has potential role between hypertension and target organ damage in postmenopausal hypertensive women. And the objective is to evaluate the effects of testosterone between hypertension and target organ damage in postmenopausal hypertensive women.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postmenopausal hypertensive women | – | – |
| mached hypertensive men | – | – |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A total of 322 hypertensive patients hospitalized in our department from 2016 to 2017 were enrolled. Included 161 postmenopausal hypertensive women and 161 mached hypertensive men.
Key inclusion criteria (3 listed)
- Clinical diagnosis of hypertension
- Women are all postmenopausal
- Men are matched with women.
Key exclusion criteria (13 listed)
- Secondary hypertension
- Coronary disease
- Heart failure
- Arterial fibrillation
- Previous myocardial infarction
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
Relative indexes of myocardial remodeling
Time frame: Baseline
Cardiac structure (left ventricular mass index in grams for square meter) measurement.
Ambulatory blood pressure monitoring
Time frame: Baseline
Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.
The level of testosterone (T)
Time frame: Baseline
Blood samples used to analyze the levels of sexual hormones were collected between morning 8:00 and 9:00 after an overnight fast. Testosterone (T) units on nanogram per deciliter.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Derived from this study: PubMed 41555389Zhang S, Yu H, Jing C, Liang W, Chen L, Lin Y, Li R, Yu J, Li N. Correlation between ambulatory blood pressure indices and sex hormone imbalance in hypertensive women with different menopausal durations: a cross-sectional study. Eur J Med Res. 2026 Jan 19;31(1):95. doi: 10.1186/s40001-025-03797-5.
- Derived from this study: PubMed 31118595Li N, Ma R, Wang S, Zhao Y, Wang P, Yang Z, Jin L, Zhang P, Ding H, Bai F, Yu J. The potential role of testosterone in hypertension and target organ damage in hypertensive postmenopausal women. Clin Interv Aging. 2019 Apr 29;14:743-752. doi: 10.2147/CIA.S195498. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by LanZhou University.
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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Relative indexes of myocardial remodeling (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT03451747, which also lists 2 linked publications.
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 5 Mar 2018.