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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hanna Savolainen-Peltonen
• Collaborator: University of Southern California
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Hormones; Polyestradiol phosphate

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