Chlormadinone and mammary nodules.

Combined oral contraceptives containing chlormadinone acetate and breast cancer: results of a case-control study

“…These compounds were shown in some studies to cause benign and malignant tumours in beagle dogs. Although both the results of these experiments and their relevance for human breast cancer have been questioned, these products were consequently withdrawn from public use as constituents of OCs in most countries (Vallance & Capel-Edwards, 1971;Giles et al, 1978;Kwaplen et al, 1980;El Etreby et al, 1979, El Etreby & Neumann, 1980Diszfalusy, 1982 From 1970From to 1978, the proportion of users who used products with chlormadinone decreased from 100% to 20% (Nischan & Ebeling, 1984). This variation in exposure provided a unique opportunity to investigate possible relationships between breast cancer and combined OCs with and without chlormadinone as the constituent progestogen.…”

Oral contraceptives containing chlormadinone acetate and cancer incidence at selected sites in the German Democratic Republic ‐ A correlation analysis

“…Actually, other OC steroids do cause mammary nodules in beagle dogs. Nevertheless, beagles appear to be unsuitable as an animal model for the assessment of carcinogenicity of progestogenic agents (Vallance and Capel-Edwards, 1971;Giles et al, 1978;Kwaplen et a!., 1980;El Etreby et al, 1979a,b;El Etreby and Neumann, 1980;Diczfalusy, 1982).…”

Incidence of breast nodules in women receiving multiple doses of medroxyprogesterone acetate

“…The Food and Drug Administration of the USA has prescribed long-term studies of all systemic contraceptive drugs, using, among other methods, beagle bitches and doses of up to 25 times the human contraceptive dose as expressed in terms of mg/kg body weight (Goldenthal, 1968(Goldenthal, , 1969. A study of the oral progestational agent, chlormadinone acetate, showed an increased incidence of non-malignant fibroadenoma in the breast tissue of the test animals (Vallance & Capel-Edwards, 1971) leading to concern over the long-term usage of this and chemically-related compounds in the human female. On the basis of studies using doses related to the human contraceptive dose, on a body weight basis, chlormadinone and the other 17a-hydroxy-progesterone derivatives have been thought to have a greater propensity to produce mammary nodules than the nortestosterone derivatives.…”