Cardiovascular risk factors and combined estrogen-progestin replacement therapy: a placebo-controlled study with nomegestrol acetate and estradiol.
OBJECTIVE
To assess the effects of oral E2 replacement therapy combined with nomegestrol acetate, a 19-norprogesterone derivative, on cardiovascular risk factors.


METHODS
A double-blind randomized prospective study comparing the effect of a placebo and two oral E2-nomegestrol acetate combinations (1 mg-2.5 mg and 1.5 mg-3.75 mg) over a three-cycle trial.


METHODS
Department of Internal Medicine and Nutrition, Hotel-Dieu, Paris, France.


METHODS
Fifty-seven nonhysterectomized women with natural menopause.


METHODS
Blood pressure, renin substrate, glucose, total cholesterol, high-density and low-density lipoprotein cholesterol, triglycerides, apoproteins A1 and B, lipoprotein(a), antithrombin III, fibrinogen, plasminogen, prothrombin fragment 1 + 2, protein C, and total and free protein S.


RESULTS
Both treatments significantly reduced menopausal complaints, total cholesterol, low-density lipoprotein cholesterol and lipoprotein(a). Treatment with the 1.5 mg-3.75 mg combination resulted in a significant increase in apolipoprotein A1. No significant change were observed in other parameters.


CONCLUSIONS
Sequentially combined with oral E2 in hormone replacement therapy, nomegestrol acetate had favorable effects on plasma lipids and lipoproteins. This nonandrogenic progestin decreased lipoprotein(a) levels as observed previously with medroxyprogesterone acetate combined with conjugated equine estrogens.
Conard
J
J
Department of Hemostasis, Hotel-Dieu, Paris, France.
Basdevant
A
A
Thomas
J L
JL
Ochsenbein
E
E
Denis
C
C
Guyene
T T
TT
Degrelle
H
H
D001059:Apoproteins / Q000097:blood; D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure / Q000187:drug effects; D002318:Cardiovascular Diseases / Q000453:epidemiology* / Q000209:etiology* / Q000503:physiopathology; D002784:Cholesterol / Q000097:blood; D004311:Double-Blind Method; D004338:Drug Combinations; D004958:Estradiol / Q000494:pharmacology*; D015914:Estrogen Replacement Therapy / Q000592:standards*; D005260:Female; D005340:Fibrinogen / Q000032:analysis; D005640:Follicle Stimulating Hormone / Q000097:blood; D006801:Humans; D008074:Lipoproteins / Q000097:blood; D008535:Megestrol; D008875:Middle Aged; D009649:Norpregnadienes / Q000494:pharmacology*; D010958:Plasminogen / Q000032:analysis; D045167:Progesterone Congeners / Q000494:pharmacology*; D011446:Prospective Studies; D012083:Renin / Q000097:blood; D012307:Risk Factors; D014280:Triglycerides / Q000097:blood
D001059:Apoproteins; D001786:Blood Glucose; D004338:Drug Combinations; D008074:Lipoproteins; D009649:Norpregnadienes; D045167:Progesterone Congeners; D014280:Triglycerides; D004958:Estradiol; C038501:nomegestrol acetate; D005340:Fibrinogen; D010958:Plasminogen; D005640:Follicle Stimulating Hormone; D002784:Cholesterol; D008535:Megestrol; D012083:Renin