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

Randomized comparative trial between abrupt and tapered mode of discontinuation of longterm hormone therapy: Impact on endothelial function, recurrence of vasomotor symptoms and quality of life

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000328-85-FI

Enrollment

150

Registered

2017-03-23

Start date

2017-05-18

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 Classifica

Interventions

Trade Name: Divitren Pharmaceutical Form: Tablet INN or Proposed INN: ESTRADIOL VALERATE CAS Number: 979-32-8 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral us

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 ;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);Timepoint(s) of evaluation of this end point: baseline (5 +/- 1 week), 13 (+/- 1 week)	—

Measure

Time frame

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 ;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);Timepoint(s) of evaluation of this end point: baseline (5 +/- 1 week), 13 (+/- 1 week)

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Secondary

Measure	Time frame
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) ;Timepoint(s) of evaluation of this end point: baseline, 13 (+/-1) week, 19 (+/-1) week	—

Measure

Time frame

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) ;Timepoint(s) of evaluation of this end point: baseline, 13 (+/-1) week, 19 (+/-1) week

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Countries

Finland

Contacts

Public ContactWomen's Hospital

Helsinki University Hospital, Obstetrics and Gynecology

358094711

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026