NCT04050592

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

Randomized Comparative Trial Between Abrupt and Tapered Discontinuation of Postmenopausal Hormone Therapy: Impact on Endothelial Function, Recurrence of Vasomotor Symptoms and Quality of Life

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Hanna Savolainen-Peltonen · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Menopause
• Atherosclerosis
• Cardiovascular Diseases
• Estrogen Replacement Therapy

Interventions

Type	Name	Description
DRUG	Estradiol	Active intervention is estradiol. Hormone therapy (HT) of all 150 participants will be standardized to 2.0 mg of oral estradiol (E2) without progestogen for six weeks prior to randomization. After that participants will be randomized into three groups (A, B, C) of equal size.
OTHER	Placebo	Those in groups A and B will switch from estradiol to placebo at the beginning of the 10th week after abrupt or tapered discontinuation of HT.

Timeline

• Start date: 2020-02-19
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2019-08-08
• Last updated: 2021-02-15

Locations

1 site across 1 country: Finland