Impact of estetrol (E4) on hemostasis, metabolism and bone turnover in postmenopausal women.
Climacteric
; 26(1): 55-63, 2023 02.
Article
in En
| MEDLINE
| ID: mdl-36399023
ABSTRACT
OBJECTIVE:
This study aimed to determine the effects of estetrol (E4) on hemostasis, lipids, carbohydrate metabolism and bone turnover in postmenopausal women.METHODS:
This study was a multicenter, randomized, double-blind placebo-controlled phase 2 trial. Participants (n = 180, age 43-64 years) received E4 2.5 mg, 5 mg, 10 mg and 15 mg or placebo once daily for 12 weeks. Changes from baseline at week 12 were evaluated versus placebo for hemostasis parameters, sex hormone binding globulin (SHBG), lipids, carbohydrate metabolism and bone markers.RESULTS:
Changes for hemostasis parameters were minimal with a small increase only in the normalized activated protein C sensitivity ratio in the E4 15 mg group versus placebo. SHBG increased in the E4 5 mg, 10 mg and 15 mg groups versus placebo. High-density lipoprotein cholesterol increased in all E4 groups; changes were not consistent for other lipids. Significant decreases versus placebo were seen for insulin resistance (E4 10 mg group), hemoglobin A1c (E4 15 mg group) and type 1 collagen C-terminal telopeptide (E4 10 mg and 15 mg groups). Small decreases in osteocalcin in the E4 5 mg, 10 mg and 15 mg groups were significant versus the increase observed in placebo.CONCLUSION:
E4 had limited impact on hemostasis and potentially beneficial effects on lipids, carbohydrate metabolism and bone turnover.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Estetrol
Type of study:
Clinical_trials
Limits:
Adult
/
Female
/
Humans
/
Middle aged
Language:
En
Journal:
Climacteric
Journal subject:
GINECOLOGIA
Year:
2023
Document type:
Article
Affiliation country:
Belgium