Clinical trial NCT04050592: Discontinuation of Postmenopausal Hormone Therapy: Impact on the Cardiovascular System and Quality of Life
Official title: Randomized Comparative Trial Between Abrupt and Tapered Discontinuation of Postmenopausal Hormone Therapy: Impact on Endothelial Function, Recurrence of Vasomotor Symptoms and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Menopause
Atherosclerosis
Cardiovascular Diseases
Estrogen Replacement Therapy
Keywords: Randomized Controlled Trial
Menopause
Hormone Therapy
Vasomotor symptoms
Quality of Life
Cardiovascular diseases
Endothelium
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern California
First posted: 2019-08-08
Enrollment: 150
Sex: FEMALE
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Brachial artery flow-mediated dilation (FMD)
timeFrame: 8 and 14 weeks
Secondary outcomes:
measure: Symptom diary
timeFrame: 5 and 13 weeks
measure: Women's Health Questionnaire
timeFrame: 5 and 13 weeks
measure: Symptom questionnaire
timeFrame: 5 and 13 weeks
measure: European Quality of Life Instrument
timeFrame: 5 and 13 weeks
measure: Female Sexual Function Index
timeFrame: 5 and 13 weeks
measure: Biomarker: Concentration of endothelin-1
timeFrame: 5 and 8 weeks
measure: Biomarker: Concentration of nitrite and nitrate
timeFrame: 5 and 8 weeks
measure: Biomarker: Concentration of Asymmetric Dimethylarginine
timeFrame: 5 and 8 weeks
measure: Biomarker: concentration of sex hormones
timeFrame: 2, 5 and 8 weeks
measure: Biomarker: Concentration of coagulation factors
timeFrame: 5 and 8 weeks
measure: Biomarker: Concentration of lipids
timeFrame: 5 and 8 weeks
measure: Biomarker: Concentration of carbohydrate metabolism
timeFrame: 5 and 8 weeks
measure: Biomarker: Concentration of oxidative stress
timeFrame: 5 and 8 weeks
measure: Biomarker: Concentration of inflammatory factors
timeFrame: 5 and 8 weeks
measure: Biomarker: Concentration of advanced glycation end products and soluble form of their receptor
timeFrame: 5 and 8 weeks
measure: Biomarker: Concentration of cellular adhesion molecules
timeFrame: 5 and 8 weeks
measure: Concentration of matrix metalloproteinases
timeFrame: 5 and 8 weeks
measure: Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: 1 and 19 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUS Women's Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Tomi Mikkola, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: