Clinical equivalence of intranasal estradiol and oral estrogens for postmenopausal symptoms.
OBJECTIVE
The aim was to demonstrate the equivalent efficacy of intranasal estradiol (Aerodiol Servier, Istanbul, Turkey) 300 mg/day relative to a standard oral estradiol therapy of 2 mg/day and to assess the therapeutic value of the potential benefits of Aerodiol.


METHODS
Two hundred and one postmenopausal women with severe menopausal symptoms were recruited to the trial. Women received either intranasal Aerodiol 300 microg/day (one spray delivery of 150 microg per nostril) or an oral estradiol 2 mg for 24 weeks. Severity of symptoms were compared based on the Kupperman index (KI) at the end of 24 weeks.


RESULTS
The KI score decreased markedly in both groups between W0 and W24. At W24, the two treatments were shown to be statistically equivalent (P<0.001). The incidence of adverse events was very similar in both groups; those related to treatment were of mild or moderate intensity in 95% of cases for the nasal group and 90% for the oral group.


CONCLUSIONS
In conclusion, pulsed estrogen therapy using Aerodiol is safe, easily used and highly efficient in alleviating postmenopausal symptoms with a dose of 300 microg. The dose of 300 microg in one administration per day offers the optimal therapy whilst being easily adaptable to each patient's clinical response.
Ozsoy
M
M
Department of Obstetrics and Gynecology, Süleyman Demirel University, School of Medicine, Isparta, Turkey. ozsoymesut@hotmail.com
Oral
B
B
Ozsoy
D
D
D000281:Administration, Intranasal; D000284:Administration, Oral; D001007:Anxiety / Q000188:drug therapy; D004958:Estradiol / Q000008:administration & dosage*; D015914:Estrogen Replacement Therapy / Q000379:methods*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause / Q000187:drug effects*; D011446:Prospective Studies; D012720:Severity of Illness Index; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy; D013546:Sweating / Q000187:drug effects
D004958:Estradiol