Pharmacokinetics of Fem7, a once-weekly, transdermal oestrogen replacement system in healthy, postmenopausal women.
This open-label, randomized study in 36 healthy postmenopausal women, investigated the pharmacokinetics of Fem7, (an oestradiol matrix-type patch), at doses of 25, 50, 75 and 100 microg/24 h, applied once weekly. Maximum plasma concentrations of oestradiol and oestrone were observed 14-20 h after patch application, remaining within the therapeutic range until removal, and returning to baseline within 12 h thereafter. Plasma oestradiol concentrations increased in a dose-dependent manner for all four doses, and plasma oestrone increased for the three highest doses. Fem7 treatment was well tolerated at all four doses and no severe adverse reactions were reported. Fem7 is a convenient and well-tolerated form of hormone-replacement therapy that delivers oestradiol in a consistent and predictable manner.
Department Clinical Pharmacology, Merck KGaA, Darmstadt, Germany.
D
D
Geyer
M G
MG
Gerrits
A
A
Renoux
W
W
Uhl
D000279:Administration, Cutaneous; D000368:Aged; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D015914:Estrogen Replacement Therapy; D004970:Estrone / Q000097:blood; D005260:Female; D006801:Humans; D007700:Kinetics; D008875:Middle Aged; D017698:Postmenopause
D004970:Estrone; D004958:Estradiol