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Influence of gestodene and desogestrel as components of low-dose oral contraceptives on the pharmacokinetics of ethinyl estradiol (EE2), on serum CBG and on urinary cortisol and 6 beta-hydroxycortisol.
Contraception. 1993 Mar; 47(3):263-81.C

Abstract

A randomized controlled clinical trial was undertaken over a 6-month treatment period with two low-dose combined oral contraceptives (OC) to investigate whether the metabolism and elimination of ethinyl estradiol (EE2) is differently influenced by the two progestational components gestodene (G) and desogestrel (D), an issue which has been very controversial recently. The two formulations contained 30 micrograms EE2 each, together with either 75 micrograms G or 150 micrograms D. Of the 40 young women recruited for each formulation, 31 of each group were available for statistical evaluation. The pharmacokinetics of serum EE2 were studied on day 1, 10 and 21 of cycle 1, 3 and 6. There were no significant differences between the two groups in any cycle with respect to parameters measured. This was true for the distinct intracyclical rise in the mean EE2 serum levels from day 1 to day 10 and the smaller further increase between day 10 and day 21, with no change in this respect between the cycles studied. Respective changes were seen with regard to the area under the EE2 serum concentration curve up to 4 and 24 hours (AUC0-4 and AUC0-24), cmax and tmax of serum EE2. The estrogen-dependent corticoid-binding globulin (CBG) increased similarly in the two groups intracyclically and slightly also intercyclically at all times tested. Except for the first treatment cycle, urinary excretion of cortisol and 6 beta-hydroxycortisol displayed a tendency to lower values intracyclically as well as intercyclically, again with no differences between the two groups. Also, the 6 beta-hydroxycortisol-to-cortisol ratio was not different between the groups, showing a slight tendency to rise from about 4 at the beginning of the medication to around 5.5 at the end of the 6th treatment cycle in both groups. It is concluded that G and D as components of low-dose OCs exert comparable effects on the metabolism and elimination of EE2.

Authors+Show Affiliations

Abteilung.f. Gynäkologische Endokrinologie, Klinikum Steglitz, Freie Universität Berlin.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

8462317

Citation

Hammerstein, J, et al. "Influence of Gestodene and Desogestrel as Components of Low-dose Oral Contraceptives On the Pharmacokinetics of Ethinyl Estradiol (EE2), On Serum CBG and On Urinary Cortisol and 6 Beta-hydroxycortisol." Contraception, vol. 47, no. 3, 1993, pp. 263-81.
Hammerstein J, Daume E, Simon A, et al. Influence of gestodene and desogestrel as components of low-dose oral contraceptives on the pharmacokinetics of ethinyl estradiol (EE2), on serum CBG and on urinary cortisol and 6 beta-hydroxycortisol. Contraception. 1993;47(3):263-81.
Hammerstein, J., Daume, E., Simon, A., Winkler, U. H., Schindler, A. E., Back, D. J., Ward, S., & Neiss, A. (1993). Influence of gestodene and desogestrel as components of low-dose oral contraceptives on the pharmacokinetics of ethinyl estradiol (EE2), on serum CBG and on urinary cortisol and 6 beta-hydroxycortisol. Contraception, 47(3), 263-81.
Hammerstein J, et al. Influence of Gestodene and Desogestrel as Components of Low-dose Oral Contraceptives On the Pharmacokinetics of Ethinyl Estradiol (EE2), On Serum CBG and On Urinary Cortisol and 6 Beta-hydroxycortisol. Contraception. 1993;47(3):263-81. PubMed PMID: 8462317.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Influence of gestodene and desogestrel as components of low-dose oral contraceptives on the pharmacokinetics of ethinyl estradiol (EE2), on serum CBG and on urinary cortisol and 6 beta-hydroxycortisol. AU - Hammerstein,J, AU - Daume,E, AU - Simon,A, AU - Winkler,U H, AU - Schindler,A E, AU - Back,D J, AU - Ward,S, AU - Neiss,A, PY - 1993/3/1/pubmed PY - 1993/3/1/medline PY - 1993/3/1/entrez KW - Adrenal Cortex Hormones KW - Biology KW - Clinical Research KW - Comparative Studies KW - Contraception KW - Contraceptive Agents, Estrogen--pharmacodynamics KW - Contraceptive Agents, Female--pharmacodynamics KW - Contraceptive Agents, Progestin KW - Contraceptive Agents--pharmacodynamics KW - Contraceptive Methods KW - Desogestrel KW - Endocrine System KW - Enzymatic Effects KW - Enzymes And Enzyme Inhibitors KW - Ethinyl Estradiol--pharmacodynamics KW - Family Planning KW - Gestodene KW - Hematological Effects KW - Hemic System KW - Hormones KW - Human Volunteers KW - Oral Contraceptives KW - Oral Contraceptives, Combined KW - Oral Contraceptives, Low-dose KW - Physiology KW - Research Methodology KW - Research Report KW - Studies KW - Transcortin Bound Cortisol Alterations SP - 263 EP - 81 JF - Contraception JO - Contraception VL - 47 IS - 3 N2 - A randomized controlled clinical trial was undertaken over a 6-month treatment period with two low-dose combined oral contraceptives (OC) to investigate whether the metabolism and elimination of ethinyl estradiol (EE2) is differently influenced by the two progestational components gestodene (G) and desogestrel (D), an issue which has been very controversial recently. The two formulations contained 30 micrograms EE2 each, together with either 75 micrograms G or 150 micrograms D. Of the 40 young women recruited for each formulation, 31 of each group were available for statistical evaluation. The pharmacokinetics of serum EE2 were studied on day 1, 10 and 21 of cycle 1, 3 and 6. There were no significant differences between the two groups in any cycle with respect to parameters measured. This was true for the distinct intracyclical rise in the mean EE2 serum levels from day 1 to day 10 and the smaller further increase between day 10 and day 21, with no change in this respect between the cycles studied. Respective changes were seen with regard to the area under the EE2 serum concentration curve up to 4 and 24 hours (AUC0-4 and AUC0-24), cmax and tmax of serum EE2. The estrogen-dependent corticoid-binding globulin (CBG) increased similarly in the two groups intracyclically and slightly also intercyclically at all times tested. Except for the first treatment cycle, urinary excretion of cortisol and 6 beta-hydroxycortisol displayed a tendency to lower values intracyclically as well as intercyclically, again with no differences between the two groups. Also, the 6 beta-hydroxycortisol-to-cortisol ratio was not different between the groups, showing a slight tendency to rise from about 4 at the beginning of the medication to around 5.5 at the end of the 6th treatment cycle in both groups. It is concluded that G and D as components of low-dose OCs exert comparable effects on the metabolism and elimination of EE2. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/8462317/Influence_of_gestodene_and_desogestrel_as_components_of_low_dose_oral_contraceptives_on_the_pharmacokinetics_of_ethinyl_estradiol__EE2__on_serum_CBG_and_on_urinary_cortisol_and_6_beta_hydroxycortisol_ L2 - https://linkinghub.elsevier.com/retrieve/pii/0010-7824(93)90043-7 DB - PRIME DP - Unbound Medicine ER -