title: Multicentred clinical study of the metabolic effect of the monthly injectable contraceptive containing dihydroxyprogesterone acetophenide 150 mg + estradiol enanthate 10 mg.
abstract: The metabolic effect of the monthly injectable contraceptive containing dihydroxyprogesterone acetophenide (DHPA) 150 mg + estradiol enanthate (EEn) 10 mg was compared to that of other regularly used contraceptive methods (pills containing: ethinylestradiol (EE) 0.050 mg + levonorgestrel (LNG) 0.250 mg, EE 0.030 mg + LNG 0.150 mg; EE 0.030/0.040/0.030 mg + LNG 0.050/0.075/0.0125 mg; norethisterone enanthate (NEE) 200 mg i.m.; non-hormonal methods). Serum triglycerides, HDL/LDL-cholesterol, copper, ceruloplasmin, total and free cortisol, CBG, total and free testosterone and SHBG in chronic users were determined. A total of 237 women took part in this study. Taking users of non-hormonal methods as control, triglyceride levels were higher, and total and free testosterone levels were lower in women using DHPA 150 mg + EEn 10 mg and in those taking contraceptive pills (p less than 0.05 - 0.01). Such modifications were slightly less in the group using the injectable. The effects of DHPA 150 mg + EEn 10 mg on HDL/LDL-cholesterol copper, ceruloplasmin, CBG, total and free cortisol and SHBG were rare or non-existent. Nevertheless, the contraceptive pills (even the low-dose formulations) correlate with modifications of all those variables, which were highly significant in comparison with the injectable (p less than 0.01) and with non-hormonal methods (p less than 0.01); there were no differences between the last two methods. The results suggest that the metabolic effect of DHPA 150 mg + EEn 10 mg is not higher than that of the commonly used oral contraceptives. On the other hand, they do not suggest that the dose contained in this injectable is exaggerated. There is no evidence that it produces accumulation of effects in the organism. These findings should be taken into account when referring to the long-term safety of this injectable.
authors.affiliation: Farmerit S.A., Medical Department, Buenos Aires, Argentina.
authors.forename: J C
authors.initials: JC
authors.lastname: Wiemeyer
authors.forename: C L
authors.initials: CL
authors.lastname: Sagasta
authors.forename: J M
authors.initials: JM
authors.lastname: Roncales Mateo
authors.forename: A C
authors.initials: AC
authors.lastname: Lavarello
authors.forename: L A
authors.initials: LA
authors.lastname: Angel de Toro
authors.forename: R
authors.initials: R
authors.lastname: Salas Diaz
mesh_terms: D000328:Adult; D000523:Algestone / Q000494:pharmacology*; D000463:Algestone Acetophenide / Q000031:analogs & derivatives*; D000704:Analysis of Variance; D002570:Ceruloplasmin / Q000378:metabolism; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003270:Contraceptive Agents / Q000494:pharmacology*; D003277:Contraceptives, Oral, Combined / Q000494:pharmacology; D003280:Contraceptives, Oral, Synthetic / Q000494:pharmacology; D003300:Copper / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004958:Estradiol / Q000031:analogs & derivatives* / Q000494:pharmacology; D004997:Ethinyl Estradiol / Q000494:pharmacology; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D007267:Injections; D016912:Levonorgestrel; D015337:Multicenter Studies as Topic; D009640:Norethindrone / Q000494:pharmacology; D009644:Norgestrel / Q000494:pharmacology; D012738:Sex Hormone-Binding Globulin / Q000378:metabolism; D013739:Testosterone / Q000097:blood; D014156:Transcortin / Q000378:metabolism; D014280:Triglycerides / Q000097:blood; D044465:White People
chemical_list: D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D003270:Contraceptive Agents; D003277:Contraceptives, Oral, Combined; D003280:Contraceptives, Oral, Synthetic; D012738:Sex Hormone-Binding Globulin; D014280:Triglycerides; D009644:Norgestrel; D000523:Algestone; D013739:Testosterone; D004997:Ethinyl Estradiol; D004958:Estradiol; D016912:Levonorgestrel; D003300:Copper; D014156:Transcortin; D002570:Ceruloplasmin; D000463:Algestone Acetophenide; C002027:estradiol enanthate; D009640:Norethindrone; D006854:Hydrocortisone