Back to the Top
We are planning to do a Drug-interactions study with OC's and a CYP3A
inhibitor.
In using women with child-bearing potential, there seems to be a long
lead-in period to stabilize the OC's before the start of the DDI phase.
My question is can we do this study in post-menopausal women and not
have the lead-in phase?
Thanks,
Vernon
Back to the Top
Vernon,
The FDA usually likes women of all ages. Take precautions, like
ensuring women are on a reliable form of birth control, if sexually
active. Conduct pregnancy tests at screen, at each study leg, and at
study closure. CROs usually have a good template. You may also be
required to conduct a study with midazolam. Good luck. Harold.
Harold Boxenbaum, Ph.D.
Arishel Inc.
Pharmaceutical n Medical n Biotechnology n Nutraceutical Consultant
14621 Settlers Landing Way
North Potomac, MD 20878-4305
Phone: (301) 424-2806
Fax: (301) 424-8563
E-Mail: harold.-a-.arishel.com
www.arishel.com
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)