CDB-2914 /PROGESTERONE RECEPTOR MODULATOR /VAGINAL RING

$0U54FY2002HDNIH

Population Council, New York NY

Investigators

Linked publications, trials & patents

Paper 35971301 Paper 34851278 Paper 34323226 Paper 34157312 Paper 33369182 Paper 31278979 Paper 31112404 Paper 30808893 Paper 30763581 Paper 30649248 Paper 30608903 Paper 30056046 Paper 30016153 Paper 29846284 Paper 29497043 Paper 29453576 Paper 29453575 Paper 29434191 Paper 29410206 Paper 29241443 Paper 29174914 Paper 29150642 Paper 29089336 Paper 29040437 Paper 28965865 Paper 28923514 Paper 28865027 Paper 28487282 Paper 28450047 Paper 28439067 Paper 28323988 Paper 28218625 Paper 28124577 Paper 28123928 Paper 28063768 Paper 28036337 Paper 27831554 Paper 27824503 Paper 27815338 Paper 27635303 Paper 27611949 Paper 27559491 Paper 27436542 Paper 27358069 Paper 27292315 Paper 27182439 Paper 27145014 Paper 27108805 Paper 26990065 Paper 26968934 Paper 26957088 Paper 26894662 Paper 26791048 Paper 26779951 Paper 26758796 Paper 26698679 Paper 26687990 Paper 26678449 Paper 26628556 Paper 26608945 Paper 26537751 Paper 26510796 Paper 26413414 Paper 26413410 Paper 26357922 Paper 26048141 Paper 25913180 Paper 25901598 Paper 25887390 Paper 25714812 Paper 25652626 Paper 25640330 Paper 25620224 Paper 25588509 Paper 25456071 Paper 25414694 Paper 25217631 Paper 25193534 Paper 25159326 Paper 25117412 Paper 25092805 Paper 25051438 Paper 25043918 Paper 24985332 Paper 24967734 Paper 24735648 Paper 24727349 Paper 24578181 Paper 24532171 Paper 24467744 Paper 24381802 Paper 24359954 Paper 24169556 Paper 23942142 Paper 23885308 Paper 23885306 Paper 23885305 Paper 23880313 Paper 23687615 Paper 23665760

Abstract

DESCRIPTION (provided by applicant): A new progesterone receptor modulator, CDB-29 14, with potent antiovulatory properties will be investigated for its potential as a contraceptive for women when delivered through a sustained-released system such as a contraceptive vaginal ring. The molecule has been synthesized and developed by the National Institute of Child Health and Human Development (NICHD) for emergency contraception. Toxicology studies conducted at the NICHD indicate that the compound is safe, and the Food and Drug Administration (FDA) has approved an Investigational New Drug for clinical study. CDB-2914 binds to the progesterone receptor (PR) with high affinity and is a potent progesterone antgonist (PA). It exhibits potent antiovulatory properties in animal models. These properties of CDB-2914 make it attractive as a potential contraceptive, and preliminary studies suggest the possibility of delivering CDB-2914 continuously at low doses via a silastic vaginal ring. The research project described in this proposal will include the following studies: 1) The mechanism of action at the ovarian level will be explored. 2) CDB-2914 will be formulated into vaginal gel and rings and will involve assessment of in vitro release and stability studies. The extensive experience of The Population Council in laboratory scale manufacture of contraceptive rings (CRs) and in evaluation of their clinical performance provides a firm base for completing the development of the CDB-2914 device. 3) A radioimmunoassay will be set up for CDB-2914 and validated for kinetic studies to be conducted in animals and in women. 4) The potential proliferative action of CDB-2914 on human breast cells will be investigated as well for safety purposes, in anticipation of eventual long-term contraceptive efficacy studies in women. Parallel studies in women and monkeys, which relate to the above studies but for which funding has been obtained or will be requested from other sources, will be described separately. Ultimately, this new estrogen-free method should be associated with fewer side effects than estrogen-containing contraceptives and will likely induce endometrial changes resulting in amenorrhea, a condition highly acceptable to women.

View original record on NIH RePORTER →