Effects on serum lipid and leptin levels of three different doses of norethisterone continuously combined with a fixed dose of 17beta-estradiol for nasal administration in postmenopausal women: a controlled, double-blind study.
OBJECTIVE
To evaluate the effect of intranasal continuous combined hormone therapy on serum lipids and leptin levels in healthy postmenopausal women.


METHODS
Multicenter, double-blind, double-dummy, randomized, controlled study conducted in parallel groups.


METHODS
Outpatient clinics of three Spanish hospitals and two private health centers.


METHODS
A total of 333 healthy postmenopausal women aged 40 to 75 years.


METHODS
Women were randomly allocated to either one of three different doses of norethisterone (50 microg/day, 175 microg/day, or 550 microg/day) continuously combined with a fixed dose of 17beta-estradiol (350 microg/day) for nasal administration, or 17beta-estradiol at 2 mg/day combined with oral norethisterone acetate at 1 mg/day.


METHODS
Serum lipid, glucose, and leptin levels were assessed at baseline and after 12, 24, 36, and 52 weeks of treatment.


RESULTS
Overweight women (body mass index >25 kg/m(2)) had higher baseline leptin levels, but these levels increased in all groups across the study unrelated to body mass index. Both intranasal and oral therapy had the effect of increasing the levels of leptin after 24 weeks in healthy postmenopausal women. As expected, total cholesterol and low-density lipoprotein cholesterol levels decreased and high-density lipoprotein levels increased in the four groups.


CONCLUSIONS
Body mass index is a strong determinant of serum leptin levels in healthy postmenopausal women; serum leptin increased in all the hormone therapy regimes.
Castelo-Branco
Camil
C
Institute Clinic of Gynecology, Obstetrics, and Neonatology, Hospital Clinic, Faculty of Medicine-University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain. castelo@sego.es <castelo@sego.es>
Palacios
Santiago
S
Vázquez
Francisco
F
Villero
José
J
Ferrer
Javier
J
Ascaso
Carlos
C
Balasch
Juan
J
D000281:Administration, Intranasal; D000328:Adult; D000368:Aged; D015992:Body Mass Index; D003270:Contraceptive Agents / Q000008:administration & dosage / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D004958:Estradiol / Q000008:administration & dosage / Q000494:pharmacology*; D015914:Estrogen Replacement Therapy; D005260:Female; D006801:Humans; D020738:Leptin / Q000097:blood*; D008055:Lipids / Q000097:blood*; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000494:pharmacology*; D010919:Placebos; D017698:Postmenopause / Q000097:blood* / Q000187:drug effects*
D003270:Contraceptive Agents; D004338:Drug Combinations; D020738:Leptin; D008055:Lipids; D010919:Placebos; D004958:Estradiol; D009640:Norethindrone