Abstract

The primary objective is to modify the current formulation of CAPRONOR (registered trademark), a biodegradable device based on poly (epsilon caprolactone), designed for the sustained delivery of contraceptive levels of levonorgestrel for a minimum period of one year. Phase II clinical trials had indicated that serum levels of levonorgestrel were lower than desired for near 100% effective contraception, and there was a downward drift over time. Also the shelf-life of the current device needs to be increased. Toxicological studies and Phase I clinical trial also will be done to evaluate the performance of the modified CAPRONOR (registered trademark) device under this contract.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research and Development Contracts (N01)
Project #
N01HD082916-002
Application #
3653332
Study Section
Project Start
1988-09-30
Project End
1991-09-29
Budget Start
1989-09-28
Budget End
1991-09-29
Support Year
Fiscal Year
1989
Total Cost
Indirect Cost

  Institution

Name
Research Triangle Institute
Department
Type
DUNS #
131606022
City
Research Triangle Park
State
NC
Country
United States
Zip Code
27709