title: Medroxyprogesterone acetate: steady-state pharmacokinetics bioequivalence of two oral formulations.
abstract: Two micronized oral formulations of medroxyprogesterone acetate (MPA) (Farlutal and Clinovir) were compared in order to evaluate their relative bioavailability. Sixteen female patients with metastatic breast cancer were entered in a randomized cross-over study on 500-mg MPA tablets repeatedly administered (twice daily for 20 days). At the steady state, similar mean +/- SD serum levels of MPA were obtained (131 +/- 44 ng/ml for Farlutal and 136 +/- 45 ng/ml for Clinovir) and the two formulations proved to be bioequivalent (confidence interval at a significance level of 0.95 = 93%-107%).
authors.affiliation: Abteilung für Experimentelle Endokrinologie, Universitätsfrauenklinik Johannes-Gutenberg-Universität Mainz, Federal Republic of Germany.
authors.forename: K
authors.initials: K
authors.lastname: Pollow
authors.forename: R
authors.initials: R
authors.lastname: Kreienberg
authors.forename: N
authors.initials: N
authors.lastname: Di Pietro
mesh_terms: D000284:Administration, Oral; D000970:Antineoplastic Agents / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D008525:Medroxyprogesterone / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D017258:Medroxyprogesterone Acetate; D008875:Middle Aged; D013810:Therapeutic Equivalency
chemical_list: D000970:Antineoplastic Agents; D017258:Medroxyprogesterone Acetate; D008525:Medroxyprogesterone