Inclusion Criteria in studies of postmenopausal females [Design Issues]

posted by JPL  – Vienna, 2009-02-05 16:12 (6354 d 18:53 ago) – Posting: # 3184
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Dear Muneesh,

❝ 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. Then

❝ what levels should we consider for -estradiol and FSH in studies

❝ of postmenopausal females.


Are these normal ranges the published ones for that age? Notice, that normal ranges depend on the laboratory, which is analyzing the samples.

❝ 2. What should be the range for BMI as it is difficult to get BMI between

❝ 18 and 25 in that age group.


It dpends on the influence of the BMI on the endpoint.

@3: Again; it depends on your endpoint. If the concomitant mediccation is suggested to have a high impact, these patients are excluded often. If the impact is low, they may continue intake all over the study to have the same bias with all measurements. Alternatively the intake may be stopped (depending on the medication), but this has to be done as long before the study starts as possible.

❝ 4. What about subjects having diabetes and taking medicines for the same.


The same as to point 3.

Regards,
JPL

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