Role of nonhuman primate models in the discovery and clinical development of selective progesterone receptor modulators (SPRMs)

Kristof Chwalisż, Kristof Chwalisz, Ramesh C. Garg, Ramesh Garg, Robert Brenner, Ov D. Slayden, Ov Slayden, Craig A. Winkel, Craig Winkel, Walter Elger, W. Elger
Reproductive biology and endocrinology : RB&E · 2006 · vol. 4(S1) , pp. S8 · doi:10.1186/1477-7827-4-s1-s8 · PMID:17118172 · W1801008552
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Nonhuman primate models were critical in demonstrating the uterus-selective effects of SPRMs like asoprisnil, supporting their clinical development for conditions such as uterine leiomyomata.

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Abstract

Selective progesterone receptor modulators (SPRMs) represent a new class of progesterone receptor ligands that exert clinically relevant tissue-selective progesterone agonist, antagonist, partial, or mixed agonist/antagonist effects on various progesterone target tissues in an in vivo situation depending on the biological action studied. The SPRM asoprisnil is being studied in women with symptomatic uterine leiomyomata and endometriosis. Asoprisnil shows a high degree of uterine selectivity as compared to effects on ovulation or ovarian hormone secretion in humans. It induces amenorrhea and decreases leiomyoma volume in a dose-dependent manner in the presence of follicular phase estrogen concentrations. It also has endometrial antiproliferative effects. In pregnant animals, the myometrial, i.e. labor-inducing, effects of asoprisnil are blunted or absent. Studies in non-human primates played a key role during the preclinical development of selective progesterone receptor modulators. These studies provided the first evidence of uterus-selective effects of asoprisnil and structurally related compounds, and the rationale for clinical development of asoprisnil.

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Condition tags

endometriosis

MeSH descriptors

Drug Evaluation, Preclinical Models, Animal Primates Progesterone Congeners Progesterone Congeners Receptors, Progesterone Receptors, Progesterone Animals Endometrium Endometrium Estrenes Estrenes Estrenes Female Humans Leiomyoma Leiomyoma Mammary Glands, Animal Mammary Glands, Animal Models, Biological

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