“The female body is so much more complex than the male's. Men are far easier to study. With women, there are more hormonal cycles going on, menstrual cycle phases, and pregnancy, body mass, and dosing issues.
“And there are the issues related to prepubertal vs. childbearing age vs. menopausal stages of life. And of course, you have to take into account use of oral contraceptives or hormone replacement therapy,” he said.
Drug research on women is expensive. He noted that it costs between $1,200 and $1,500 in pretrial blood work just to determine whether a woman can participate in a trial.
And there's the ongoing need for pregnancy testing.
“I can't say enough about this. Testing once at the beginning of a yearlong study is not sufficient. In our lab, we're doing cocaine and alcohol studies. Anytime a woman in one of our studies comes to my lab, she gets a pregnancy test. “In the last decade, I've detected six women who [came] to the lab to take cocaine or alcohol and did not know they were pregnant. Testing adds to the cost of a study, but it is money well spent. You don't want to unwittingly give cocaine to a woman who's pregnant,” Dr. Lukas said.