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

Hanna Savolainen-Peltonen

Status and phase: Unknown; Phase 4

Conditions: Estrogen Replacement Therapy; Menopause; Cardiovascular Diseases; Atherosclerosis

Treatments: Other: Placebo; Drug: Estradiol

Study type: Interventional

Funder types: Other

Identifiers

NCT04050592

FINNHT1

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: Under 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

150 participants in 3 patient groups

Group A, Abrupt Discontinuation

Other group

Description:

Women in group A will discontinue HT (estradiol, 2 mg daily) abruptly after study week 9 and will continue with placebo for study weeks 10-20.

Treatment:

Other: Placebo

Drug: Estradiol

Group B, Tapered Discontinuation

Other group

Description:

Women in group B will discontinue HT (estradiol, 2 mg daily) gradually during study weeks 7-9, as follows: * weeks 7-9: 1 mg estradiol daily for 10 days and then 1 mg estradiol every other day for 11 days. * weeks 10-20: placebo

Treatment:

Other: Placebo

Drug: Estradiol

Group C, Control Group

Active Comparator group

Description:

Women in Group C, the control group, will continue with HT (estradiol, 2 mg daily) throughout the whole study period of 20 weeks.

Treatment:

Drug: Estradiol