pash413 ★ India, 2014-11-10 12:23 (3448 d 10:56 ago) Posting: # 13849 Views: 3,177 |
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Dear all I need clarity regarding the subject population to be enrolled for the USFDA study for Drospirenone;Ethinyl Estradiol tablets Oral contraceptive. As per the OGD guidance 1) Drospirenone;Ethinyl Estradiol 3 mg/0.02 mg tablets Subjects:Healthy nonpregnant females, general population 2) Drospirenone;Ethinyl Estradiol 3 mg/0.03 mg tablets Subjects: Healthy males and nonpregnant females, general population Since Drospirenone;Ethinyl Estradiol is indicated in female subjects, whether we can conduct study on both male and female subjects ?. Also what is mean by word "general population" Is it for both male and female subjects? |
Dr_Dan ★★ Germany, 2014-11-10 15:52 (3448 d 07:26 ago) @ pash413 Posting: # 13851 Views: 2,611 |
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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 — Kind regards and have a nice day Dr_Dan |
drgunasakaran1 ★★ 2014-11-10 19:42 (3448 d 03:37 ago) @ pash413 Posting: # 13853 Views: 2,607 |
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Dear Mr Pash 413, ❝ Since Drospirenone;Ethinyl Estradiol is indicated in female subjects, whether we can conduct study on both male and female subjects ?. 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. — Dr S Gunasakaran MBBS MD Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same. |