Prahalada S, Carroad E, Hendrickx A G
Contraception. 1985 Nov;32(5):497-515. doi: 10.1016/0010-7824(85)90020-4.
A single dose of MPA (Depo-Provera; Upjohn Co.; USA) was administered intramuscularly on day 27 (+/- 2) of gestation to three dosage groups of pregnant baboons. The dosage expressed as mg/kg corresponded to 1 (2.5 mg/kg), 10 (25 mg/kg) and 40 (100 mg/kg) times the human contraceptive dose equivalent (HDE) based on body weight. Injectable MPA was not teratogenic in baboons at 1x HDE. The teratogenicity was confined to the higher doses which included malformations of the external genitalia at 10x and 40x HDE and adrenal gland hypoplasia at 40x HDE. The maternal serum MPA concentrations were high during the critical period of adrenal and genital development. The pattern of MPA concentrations in maternal sera was similar between animals in the low dose group (10x HDE). In contrast, animals in the high dose group (40x HDE) showed interanimal variations in maternal serum concentrations of MPA. This study has demonstrated that injectable MPA is not teratogenic in baboons at human contraceptive dose equivalent and, even at higher doses, does not result in any nontarget organ malformations.
在妊娠第27天（±2天），对三组怀孕狒狒肌肉注射单剂量的醋酸甲羟孕酮（Depo - Provera；美国Upjohn公司）。以mg/kg表示的剂量相当于基于体重的人类避孕等效剂量（HDE）的1倍（2.5mg/kg）、10倍（25mg/kg）和40倍（100mg/kg）。在狒狒中，1倍HDE剂量的注射用醋酸甲羟孕酮没有致畸性。致畸性仅限于较高剂量，包括10倍和40倍HDE时的外生殖器畸形以及40倍HDE时的肾上腺发育不全。在肾上腺和生殖器发育的关键时期，母体血清中醋酸甲羟孕酮浓度较高。低剂量组（10倍HDE）动物之间母体血清中醋酸甲羟孕酮浓度的模式相似。相比之下，高剂量组（40倍HDE）动物的母体血清醋酸甲羟孕酮浓度存在个体差异。这项研究表明，注射用醋酸甲羟孕酮在人类避孕等效剂量下对狒狒没有致畸性，即使在更高剂量下，也不会导致任何非靶器官畸形。
