Intrauterine Device – Levo­nor­gestrel 52 mg [Design Issues]

posted by Relaxation  – Germany, 2021-06-30 17:22 (327 d 05:56 ago) – Posting: # 22445
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Dear Marianna.

Interesting question. Although I'd say its possible in principle (but have no experience myself with this specific approach for a long-term contraceptive), I would say that some more information is required.

Like is the CV you mentioned taken from a clinical trial at least similar to the intended investigation? And from a similar evaluation (point estimates and CI available, ANOVA on logarithmized values)? Or from a descriptive statistic and calculated as mean/standard deviation?
I think a link to the report of the phase II would be the best approach here, if something like that is available.

I may also say, that, given that the trial will take at least 12 months and likely hundreds of subjects in each arm will be required, it may be wise to get a biostatistician involved into the trial who can thoroughly check the available data, whether these fit.

Best regards,
Relaxation.

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