title: Investigation of the influence of two low-dose monophasic oral contraceptives containing 20 micrograms ethinylestradiol/75 micrograms gestodene and 30 micrograms ethinylestradiol/75 micrograms gestodene, on lipid metabolism in an open randomized trial.
abstract: An open comparison at a single center was performed in volunteers (n = 58) randomly allocated to two treatment groups, one receiving tablets containing 20 micrograms ethinylestradiol (EE) + 75 micrograms gestodene, and the other 30 micrograms EE + 75 micrograms gestodene. The study consisted of three treatment-free pre-cycles, followed by thirteen 28-day treatment cycles. Analysis of results revealed that there were no statistically significant differences between the two groups with regard to the plasma levels of HDL-cholesterol and its subfractions, LDL-cholesterol and apolipoproteins. There was, however, a trend toward a more favorable effect on HDL-cholesterol in the 20 micrograms EE group, where levels increased by 3% compared with the 30 micrograms EE group, where levels decreased by 9%. There was a statistically significant difference between the adjusted mean values of total triglycerides in the two groups in favor of the 20 micrograms EE group (+21%), compared with the 30 micrograms EE group (+64%) (p = 0.029). Two serious adverse events were reported (lymphadenopathy and vertigo), but neither were considered to be causally related to either study medication. The formulation containing 75 micrograms gestodene and 20 micrograms EE was shown to be a reliable and well tolerated oral contraceptive, with a favorable lipid profile.
authors.affiliation: Schering AG Geschäftsbereich Deutschland Gynäkologie, Berlin, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Brill
authors.forename: A
authors.initials: A
authors.lastname: Then
authors.forename: U
authors.initials: U
authors.lastname: Beisiegel
authors.forename: A
authors.initials: A
authors.lastname: Jene
authors.forename: C
authors.initials: C
authors.lastname: Wünsch
authors.forename: F
authors.initials: F
authors.lastname: Leidenberger
mesh_terms: D000293:Adolescent; D000328:Adult; D001053:Apolipoproteins / Q000097:blood / Q000187:drug effects / Q000378:metabolism; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage* / Q000009:adverse effects; D045166:Estradiol Congeners / Q000008:administration & dosage* / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008055:Lipids / Q000097:blood*; D008074:Lipoproteins / Q000097:blood / Q000187:drug effects / Q000378:metabolism; D009652:Norpregnenes / Q000008:administration & dosage* / Q000009:adverse effects; D010352:Patient Dropouts; D045167:Progesterone Congeners / Q000008:administration & dosage* / Q000009:adverse effects; D013607:Tablets
chemical_list: D001053:Apolipoproteins; D003277:Contraceptives, Oral, Combined; D003280:Contraceptives, Oral, Synthetic; D045166:Estradiol Congeners; D008055:Lipids; D008074:Lipoproteins; D009652:Norpregnenes; D045167:Progesterone Congeners; D013607:Tablets; C033273:Gestodene; D004997:Ethinyl Estradiol