Last Update: 08/10/2006 Printer Friendly Printer Friendly   Email This Page Email This Page  


Contraceptive and Reproductive Evaluation

Within this program area, the goal of the CRH Branch is to expand contraceptive and reproductive evaluation, by:
· Conducting epidemiological, statistical, and clinical studies for post-marketing surveillance of drugs, devices, and procedures utilized for contraception and reproductive health
· Collecting and disseminating results of research on the effects of drugs, devices, and procedures utilized for contraception and reproductive health 

These two objectives are temporally related; the first supports the conduct of research, the second ensures appropriate interpretation and distribution of research findings.

Traditionally, the Branch has evaluated contraceptive methods through epidemiological studies and clinical trials.  Although the contraceptive discovery and development activities of the Branch, discussed earlier, allow the detection of acute side effects, the clinical trials required for approval for U.S. marketing involve sample sizes that are too small and/or follow-up periods that are too short to detect less frequent events.  Thus, the CRH Branch also supports Phase IV, or post-marketing studies of available contraceptive methods, devices, or drugs.  Further, some associations between contraceptive methods and reproductive or other outcomes require larger populations, special populations, or longer observation periods than those presently required for marketing approval.


 
For More Information:
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Contact Information:
Dr Trent Mackay
Medical Officer
Address:
6100 Executive Blvd Room 8B13, MSC 7510
Rockville, MD 20852
For FedEx use:
Rockville Md 20852
Phone: 301-435-6988
Fax: 301-480-1972
E-mail:
mackayt@mail.nih.gov