Article (Scientific journals)
Plasma Estradiol Concentrations and Pharmacokinetics Following Transdermal Application of Menorest 50 or Systen (Evorel) 50
Reginster, Jean-Yves; Albert, Adelin; Deroisy, Rita et al.
1997In Maturitas, 27 (2), p. 179-86
Peer Reviewed verified by ORBi
 

Files


Full Text
Plasma Estradiol Concentrations and Pharmacokinetics Following Transdermal Application of Menorest 50 or Systen (Evorel) 50.pdf
Publisher postprint (509.72 kB)
Request a copy

All documents in ORBi are protected by a user license.

Send to



Details



Abstract :
[en] OBJECTIVES: In order to compare the pharmacokinetics of two transdermal estrogen replacement therapy (ERT) systems designed to release 50 micrograms 17 beta-estradiol/day, two studies were performed in healthy postmenopausal volunteers. METHODS: Both studies had a cross-over design and incorporated a 1-week wash-out period between treatments. In the first study, Menorest 50 and Systen 50 (Evorel 50) were compared over four days of application in 30 women. In the second, 13 women wore each of the two systems for a total of 12 days each (three patches each for 4 days), and comparison was made during the third patch period (steady state, between days 8 and 12). Plasma 17 beta-estradiol levels were assayed using specific direct radioimmunoassays, and pharmacokinetic parameters were calculated by standard methods. All the samples of the first study were re-analysed using a different radioimmunoassay and the results of both assays were compared. RESULTS: In both studies, plasma 17 beta-estradiol levels rose at a comparable rate and reached similar peak levels with each of the two formulations. Levels then remained relatively constant throughout both evaluation periods with Menorest 50, but began to decline after 12 hours in the first study and after 30 h under steady state conditions in the second study with Systen 50. The difference between the two products was statistically significant in both studies. Analysis of pharmacokinetic parameters confirmed the greater bioavailability of Menorest 50. In addition, 17 beta-estradiol levels remained within the suggested therapeutic ranges for relief of acute symptoms and protection against osteoporosis for longer periods of time with Menorest 50 than with Systen 50. CONCLUSION: Since the acute efficacy, long-term protective effects, side effects and risks associated with ERT may depend on critical threshold plasma levels, much attention should be paid to the pharmacokinetic profiles of different formulations. The comparison of these two different radioimmunoassays demonstrates the comparability of their results.
Disciplines :
Rheumatology
Author, co-author :
Reginster, Jean-Yves  ;  Université de Liège - ULiège > Département des sciences de la santé publique > Epidémiologie et santé publique
Albert, Adelin  ;  Université de Liège - ULiège > Département des sciences de la santé publique > Informatique médicale et biostatistique
Deroisy, Rita  ;  Centre Hospitalier Universitaire de Liège - CHU > Médecine de l'appareil locomoteur
Collette, Julien ;  Université de Liège - ULiège > Département des sciences biomédicales et précliniques > Département des sciences biomédicales et précliniques
Vrijens, Bernard  ;  Université de Liège - ULiège > Département de mathématique
Blacker, C.
Brion, N.
Caulin, F.
Mayolle, C.
Regnard, A.
Scholler, R.
Franchimont, P.
Language :
English
Title :
Plasma Estradiol Concentrations and Pharmacokinetics Following Transdermal Application of Menorest 50 or Systen (Evorel) 50
Publication date :
June 1997
Journal title :
Maturitas
ISSN :
0378-5122
eISSN :
1873-4111
Publisher :
Elsevier, Netherlands
Volume :
27
Issue :
2
Pages :
179-86
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 27 May 2010

Statistics


Number of views
92 (1 by ULiège)
Number of downloads
0 (0 by ULiège)

Scopus citations®
 
21
Scopus citations®
without self-citations
20
OpenCitations
 
17

Bibliography


Similar publications



Contact ORBi