Gonadal Hormone, Gonadotropin and Cardiovascular Events

Shandong First Medical University

Status: Active, not recruiting

Conditions: Aging; Menopause

Study type: Observational

Funder types: Other

Identifiers

NCT02810821

20140722

Details and patient eligibility

About

Deficiency in gonadal hormone has been considered to play a role in ageing related increased incidence of cardiovascular events. But the mechanism has not been fully elucidated. On the other hand, the dramatic increase in gonadotropin level didn't drew much attention when talking about the increased risk of cardiovascular disease during menopausal transition. This study aim to investigate the association between gonadal hormone, gonadotropin and long-term cardiovascular events.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female with intact uterus and at least one ovary
• Aged of 18 to 75 years old;

Exclusion criteria

• Pregnancy or lactation women;
• Presence of pituitary/hypothalamic disorders, polycystic ovarian syndrome or other endocrinal and metabolic disorders that known to compromise hypothalamic-pituitary-gonadal function;
• Receiving psychotropic or hormonal medications including hormonal contraception and hormone therapies;
• Taking lipid-lowering agents or hypoglycemic agents and other drugs that known to influence cardiovascular health;
• Obviously poor compliance.

Trial design

8,000 participants in 6 patient groups

female, premenopause

Description:

Women with regular menstrual cycles in normal range (22-35 days) for the previous three cycles.

female, perimenopause

Description:

Peri-menopause was defined as the presence of menses within the past 3 months with a decrease in cycle predictability in the year preceding examination or 3-11 months of amenorrhea. To investigate the association between serum FSH and cholesterol levels independent of E2, we further selected peri-menopausal subjects with the presence of menses within the past 3 months with a decrease in cycle predictability in the year preceding examination because their E2 levels have been reported to be similar to those in pre-menopause.

Serum FSH level Quartile 1

Description:

Serum FSH level: \<6.95 mIU/mL

Serum FSH level Quartile 2

Description:

Serum FSH level: 6.95-10.87 mIU/mL

Serum FSH level Quartile 3

Description:

Serum FSH level: 10.88-25.45 mIU/mL

Serum FSH level Quartile 4

Description:

Serum FSH level: \>25.45 mIU/mL