PubMed · 4188427
The source did not provide an abstract. Follow the original record for more information.
Explore connections, maps & timelines
J Kremer, J Bennen, H J Huisjes. 1969-12-27. [The mini pill].. https://pubmed.ncbi.nlm.nih.gov/4188427/
Cite the original work for its findings. Save a collection to share your selection of sources.
KEEP EXPLORING
Ethinylestradiol/chlormadinone acetate 0.03/2mg (EE/CMA) is a combined monophasic contraceptive pill with antiandrogenic properties. In a large, noncomparative, multicentre trial (< or =24 cycles of treatment per woman) and two (6- and 12-cycle) postmarketing surveillance studies, EE/CMA was effective in preventing pregnancy. EE/CMA was significantly more effective than EE/levonorgestrel 0.03/0.15 mg/day in treating women with mild-to-moderate papulopustular acne of the face and related disorders in a randomised, single-blind, multicentre trial. EE/CMA was well tolerated in clinical trials and the postmarketing surveillance studies. Adverse events were those commonly reported with oral contraceptives. As expected, the most common menstrual disturbances were breakthrough bleeding, spotting and amenorrhoea.
We describe the development of a serum chlormadinone acetate (CMA) time-resolved fluoroimmunoassay (TR-FIA). We prepared haptens (3-CMO-chlormadinone acetate and 6-chloropregna-4,6-dien-17,20-diol-3-one-20-hemisuccinate), biotinylated tracers (3(biotinylaminopropylamido) 3-CMO-chlormadinone acetate and 3-(6-chloropregna-4,6-dien-17,20-diol-3-one-20-hemisuccinylamino)1-biotinylaminopropane), and immunogens necessary for eliciting two antibodies (anti-chlormadinone acetate 3-CMO/BSA and anti-chlormadinone 20-hemisuccinate/BSA). The specificity of the assay was rigorously studied to eliminate possible interference by polar metabolites of CMA, particularly 17 alpha-acetoxy-6-chloro-3beta-hydroxypregna-4,6-diene-20-one (3beta-hydroxy metabolite), employing an easy-to-use ethylene glycol chromatographic step prior to immunoassay, so as to separate the polar metabolites, in particular the 3beta-hydroxy-CMA metabolite, from the intact CMA. The choice of the anti-CMA antibody was guided by the high assay sensitivity obtained with the anti-CMA 3-CMO/BSA antibody. The detection limit was 51pg/ml. Interassay reproducibility CVs were between 2.6 and 4.5%. This TR-FIA thus appeared to be a sensitive, specific, precise, and consequently well-suited method for measurement of serum CMA during a pharmacokinetic study in women.
The raw material for chlormadinone acetate was tested for preparation of the "Chlormadinone Acetate Reference Standard (Control 961)" of National Institute of Health Sciences. Analytical data obtained were as follows: melting point, 215. 3 degrees C; UV spectrum, lambda max = 283.5 nm; IR spectrum, the same as that of JP Chlormadinone Acetate Reference Standard (Control 885); optical rotation, [alpha]20D = -13.0 degrees; thin-layer chromatography, one impurity was detected; high-performance liquid chromatography, two impurities were detected; loss on drying, 0.01%; assay, 99.4% by spectrophotometry and 99.5% by HPLC. Based on the above results, the raw material was authorized as the Chlormadinone Acetate Reference Standard (Control 961) of National Institute of Health Sciences (Japanese Pharmacopoeia).