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Title Jadelle Levonorgestrel Rod Implants: A Summary of Scientific Data and Lesson Lwearned from Programmatoc Experience
Edition
Call Number KAPAL Perempuan 613 SIV J
ISBN/ISSN
Author(s) Irving Sivin - Personal Name
Harold Nash - Personal Name
Sandra Waldman - Personal Name
Subject(s) Contraceptives
WOMEN'S HEALTH
Classification 613
Series Title
GMD Text
Language English
Publisher Population Council
Publishing Year 2002
Publishing Place New York
Collation 48 hlm; 30 cm
Abstract/Notes The Population Council has devoted more than 30 years to the invention, development, and introduc-tion of contraceptive implants—Norplant* capsules and Jadelle* rods. Through this extended undertak-ing, the Council not only developed a new form of reversible, long-acting contraception but also pio-neered a careful process of new method introduc- tion, with attention to research, training, counseling,and consumer information. Several hundred steps went into implant inven-tion and development. Basic research determinedthe feasibility of the concept: which steroids were best suited for an implant system, how many cap-sules or rods would be needed, the dimensions and thickness of the implant walls and the inner core of the rods, and the optimum release rate and blood level for safe and effective contraception. Wyeth- Ayerst Laboratories had earlier conducted animal and toxicology studies on its synthetic progestin,levonorgestrel, and Dow Corning had conducted animal studies and human trials with its silicone rub-ber elastomer. The Council also gained access in later stages of development to National Institutes of Health toxicology studies involving continuous levo-norgestrel release by implants in animal systems. Although the Council did not have to duplicate pre-viously conducted studies, challenging tasks remained: to conceive of subdermal implants as amode of delivering contraceptive steroids; to design implants with doses presumed to prevent pregnancy; and to conduct and analyze studies demonstrating safety, effectiveness, and acceptability

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