NCT03451747

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
322

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

March 10, 2018

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2018

Completed
Last Updated

March 5, 2018

Status Verified

January 1, 2018

Enrollment Period

26 days

First QC Date

February 18, 2018

Last Update Submit

March 1, 2018

Conditions

Keywords

hypertensionfemale

Outcome Measures

Primary Outcomes (3)

  • Relative indexes of myocardial remodeling

    Cardiac structure (left ventricular mass index in grams for square meter) measurement.

    Baseline

  • Ambulatory blood pressure monitoring

    Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.

    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.

    Baseline

Study Arms (2)

postmenopausal hypertensive women

mached hypertensive men

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Clinical diagnosis of hypertension
  • Women are all postmenopausal
  • Men are matched with women.

You may not qualify if:

  • Secondary hypertension
  • Coronary disease
  • Heart failure
  • Arterial fibrillation
  • Previous myocardial infarction
  • Previous stroke
  • Malignant disease
  • Kidney failure
  • Liver failure
  • Neoplastic disease
  • Severe neurological diseases
  • Severe metabolic or organic decompensation
  • Refuse to sign the informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • Li 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.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 18, 2018

First Posted

March 2, 2018

Study Start

March 10, 2018

Primary Completion

April 5, 2018

Study Completion

April 5, 2018

Last Updated

March 5, 2018

Record last verified: 2018-01