Discontinuation of Postmenopausal Hormone Therapy: Impact on the Cardiovascular System and Quality of Life

  • STATUS
    Recruiting
  • End date
    Dec 23, 2022
  • participants needed
    150
  • sponsor
    Hanna Savolainen-Peltonen
Updated on 23 February 2021

Summary

Although the impact of postmenopausal hormone therapy (HT) on cardiovascular disease risk has been studied in several large randomized trials, little is known about the acute cardiovascular consequences of HT discontinuation. In this randomized, double-blind, placebo-controlled trial, the investigators will compare the cardiovascular consequences of abrupt and tapered modes of HT discontinuation in 150 Finnish healthy postmenopausal women under age 60 years. The primary outcome is brachial artery flow-mediated dilatation. In addition, biochemical markers will be measured during the study period of 20 weeks. Health-related quality of life, frequency of hot flush recurrence and other menopausal symptoms will be also assessed in these groups. The trial will provide new high-quality information about the cardiovascular safety as well as the correct timing and method of HT discontinuation.

Details
Condition Estrogen Replacement Therapy, Cardiovascular Disease, Menopause, Atherosclerosis, Arteriosclerosis, Atherosclerotic Cardiovascular Disease, estrogen replacement, cardiovascular diseases, cardiovascular disease (cvd), cardiovascular system diseases, cardiovascular disorders
Treatment Placebo, Estradiol
Clinical Study IdentifierNCT04050592
SponsorHanna Savolainen-Peltonen
Last Modified on23 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

healthy postmenopausal women
age 60 years
has used postmenopausal hormone therapy for at least 3 years

Exclusion Criteria

any clinically significant disease
use of regular medication
history of cardiovascular events
history of smoking
body mass index over 30 kg/m2
thickness of endometrium over 6 millimeters
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