Bioequivalence and Bioavailability Forum

Dear pash413
It seems to be strange to test an oral contraceptive in men, however, a BE study is an in-vivo quality test and does not necessarily reflect clinical use. So according FDA regulation it is possible to test Drospirenone and Ethinyl Estradiol in men. I did it in several studies (mixed population male and non-pregnant female subjects) and believe me it worked.
Kind regards
Dr_Dan

Dear Mr Pash 413,

❝ Since Drospirenone;Ethinyl Estradiol is indicated in female subjects, whether we can conduct study on both male and female subjects ?.

FDA Individual Product BE guidance on Drospirenone; Ethinyl Estradiol 3 mg/0.02 mg was recommended in March 2009 and got revised in Nov 2013.
As per the revised guidance, the study population should be only healthy non-pregnant female subjects.
Whereas, FDA Individual Product BE guidance on Drospirenone; Ethinyl Estradiol 3 mg/0.03 mg was recommended on March 2009 and not revised thereafter.
As per the Prescribing Information of Yasmin, Drospirenone/EE 3mg/0.03mg is indicated only as female oral contraceptive pill and hence, you can recruit only female non-pregnant subjects for BE study and can submit to FDA.