Discontinuation of hormone therapy: Impact on cardiovascular function, recurrence of vasomotor symptoms and quality of life

Phase 1

• Conditions: We will assess the effects of hormone therapy termination on endothelial function using biophysical (flow-mediated dilation, peripheral artery tonometry) and biochemical markers. We will compare these effects between healthy postmenopausal women who discontinue long-term HT either abruptly or gradually within four weeks. Finally, we will compare menopausal symptom recurrence and the success rate of HT discontinuation between these two treatment groups.; MedDRA version: 20.0 Level: LLT Classification code 10027311 Term: Menopause flushing System Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 20.0 Level: PT Classification code 10076936 Term: Impaired quality of life System Organ Class: 10041244 - Social circumstances; MedDRA version: 20.1 Level: LLT Classification code 10027301 Term: Menopausal hot flushes System Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 20.1 Level: PT Classification code 10060858 Term: Cardiovascular function test System Organ Class: 10022891 - Investigations; MedDRA version: 20.0 Level: PT Classification code 10027308 Term: Menopause System Organ Class: 10041244 - Social circumstances; MedDRA version: 16.1 Level: HLGT Classification code 10027309 Term: Menopause and related conditions System Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA vers; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2017-000328-85-FI
• Lead Sponsor: Helsinki University Hospital, Obstetrics and Gynecology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-23
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Healthy postmenopausal women under 60 years of age who are willing to be randomized to either continue or discontinue HT. We require that the participants have used HRT at least for 3 years before entering the study and have not attempted to discontinue HT within the last 6 months, or before that, for more than 2 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Women with any clinically significant disease or regular medication, history of cardiovascular events, smoking and body mass index over 30 kg/m2. Women with hormonal IUD or who have endometrial thickness over 6 mm when entering the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: baseline (5 +/- 1 week), 13 (+/- 1 week);Secondary Objective: Compare menopausal symptom recurrence, quality of life and the success rate of HT discontinuation between these two treatment groups;Primary end point(s): Flow-mediated dilation (FMD);<br> Main Objective: To assess the effects of hormone therapy (HT) termination on endothelial function by using biophysical and biochemical markers, and to compare these effects between women who discontinue long-term HT either abruptly or gradually<br><br>

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: baseline, 13 (+/-1) week, 19 (+/-1) week;Secondary end point(s): Peripheral artery tonometry (PAT); heart rate variability (HRV); carotid artery compliance; biochemical measurements including follicle stimulating hormone (FSH), luteinizing hormone (LH), estrone, estradiol, SHBG, HDL, LDL, VLDL, triglycerides, lipoprotein A, fasting glucose, Interferon-? (IFN-?), Monocyte chemoattractant (MCP-1), Macrophage inflammatory protein 1a (MIP-1a), Tumor necrose factor a (TNF-a), Advanced glycation end product (AGE, sRAGE), highly sensitive CRP (hsCRP), nitrite, nitrate, Asymmetric dimethyl arginine (ADMA), Endothelin-1 (ET-1), fibrinogen, plasminogen activator inhibitor-1, D-dimer, E-selectin, Intracellular cell-adhesion molecule-1 (ICAM-1), Vascular cell-adhesion molecule-1 (VCAM-1), Matrix metalloproteinases (MMPs) and Oxidized LDL (oxLDL); menopausal symptoms and quality of life (Women’s Health Questionnaire, European Quality of Life Instrument)