title: Recent developments in contraceptive implants at the Population Council.
abstract: Development of contraceptive implant methods, when based on established or on new synthetic chemical entities, is a decadal or multi-decadal process. The process often requires the cooperation of numerous investigators for laboratory work, for early Phase II trials, for dose-finding trials, and for Phase III clinical trials. The Phase III work also requires cooperation with a commercial manufacturer and potential distributor of the product. The Population Council has recently completed developmental work on two levonorgestrel-releasing implants, with filings to regulatory agencies that support extended use of Jadelle implants for 5 years and Norplant implants for 7 years. When the developmental process includes establishing the clinical properties of a molecule not yet approved by regulatory agencies, the minimum development time appears to be two decades. The status and rationale of studies of a new Nestorone-releasing, single implant developed by the Population Council for a period of use of 2 years are presented.
authors.affiliation: Population Council, Center for Biomedical Research, New York, NY, USA. sivin@popcbr.rockefeller.edu
authors.forename: Irving
authors.initials: I
authors.lastname: Sivin
authors.forename: Alfred
authors.initials: A
authors.lastname: Moo-Young
mesh_terms: D000047:Academies and Institutes; D002986:Clinical Trials as Topic; D003267:Contraception / Q000639:trends; D003271:Contraceptive Agents, Female / Q000097:blood / Q000494:pharmacology / Q000600:supply & distribution / Q000627:therapeutic use*; D004343:Drug Implants; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D009653:Norprogesterones / Q000097:blood / Q000494:pharmacology / Q000627:therapeutic use*; D017063:Outcome Assessment, Health Care
chemical_list: D003271:Contraceptive Agents, Female; D004343:Drug Implants; D009653:Norprogesterones; D016912:Levonorgestrel; C029167:ST 1435