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RegisterInclusion Criteria in studies of postmenopausal females [Design Issues]
Dear JPL,
1. Normal range of estradiol for postmenopausal females is 10.0-44.0 ng/ml and of FSH levels is 17.0-95.0 mIU/ml which is given by the laboratory which analyzing the samples. But some published studies include females with estradiol levels <20 pg/ml and FSH >40 IU/ml. So please suggest what to do.
2. BMI range of 18 and 25 is usually followed in adults to see their health status. But in the age group of 45-65, females with BMI range of 18 and 25 is very difficult to get. And there is no published literature showing influence of the BMI on the endpoint. So please suggest what to do.
3. For point 3 and 4, this is ok that if the concomitant medication is reported to have interaction with the study drug, then the intake of concomitant medication may be stopped. And if the concomitant medication is not reported to have interaction with the study drug, they may continue intake all over the study to have the same bias with all measurements.
Thank you
Regards,
Dr Muneesh Garg
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Edit: Again, please don't use UTF-characters! Use the
1. Normal range of estradiol for postmenopausal females is 10.0-44.0 ng/ml and of FSH levels is 17.0-95.0 mIU/ml which is given by the laboratory which analyzing the samples. But some published studies include females with estradiol levels <20 pg/ml and FSH >40 IU/ml. So please suggest what to do.
2. BMI range of 18 and 25 is usually followed in adults to see their health status. But in the age group of 45-65, females with BMI range of 18 and 25 is very difficult to get. And there is no published literature showing influence of the BMI on the endpoint. So please suggest what to do.
3. For point 3 and 4, this is ok that if the concomitant medication is reported to have interaction with the study drug, then the intake of concomitant medication may be stopped. And if the concomitant medication is not reported to have interaction with the study drug, they may continue intake all over the study to have the same bias with all measurements.
Thank you
Regards,
Dr Muneesh Garg
--
Edit: Again, please don't use UTF-characters! Use the
Preview -button to check your post. [Helmut]Complete thread:
- Inclusion Criteria in studies of postmenopausal females drmuneesh 2009-02-05 12:48
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Inclusion Criteria in studies of postmenopausal females JPL 2009-02-05 15:12
- Inclusion Criteria in studies of postmenopausal femalesdrmuneesh 2009-02-06 05:28
- Inclusion Criteria in studies of postmenopausal females Helmut 2009-02-06 12:28
- Inclusion Criteria in studies of postmenopausal females drmuneesh 2009-02-07 06:12
- To BMI or not to BMI, that's the question Helmut 2009-02-07 11:58
- To BMI or not to BMI, that's the question drmuneesh 2009-02-09 04:54
- To BMI or not to BMI, that's the question Helmut 2009-02-07 11:58
- Inclusion Criteria in studies of postmenopausal females drmuneesh 2009-02-07 06:12
- Interruption of background treatment ??? Ohlbe 2009-02-07 23:42
- Interruption of background treatment ??? drmuneesh 2009-02-09 04:50
- Inclusion Criteria in studies of postmenopausal females Helmut 2009-02-06 12:28
- Inclusion Criteria in studies of postmenopausal femalesdrmuneesh 2009-02-06 05:28
- Inclusion Criteria in studies of postmenopausal females JPL 2009-02-05 15:12
Ing. Helmut Schütz