TSXV:TRL.H - Post by User
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LTOWNERon Jun 16, 2014 8:49am
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Post# 22662506
Context For Stellar Tefina Results
Context For Stellar Tefina ResultsThere are 26 drugs in the sexual health area approved for men. There are zero approved for women!
20% of current Testosterone prescriptions in the US are written off-label for women and Testosterone has been used off-label in women for 50 years, unfortunately with may unpleasant side effects.
Tefina is the first drug in study with FOD as a primary endpoint in 20 years! Tefina is years ahead of any competitors. According to the US lead investigator, a huge number of women are affected and the result is as impactful on them as several major diseases.
At the request of the FDA, all the women in this study were in the "most severe" category of secondary FOD, and still the results are excellent.
58% of women in the women in the 0.6mg group had at least one orgasm vs. 43% in Placebo and this difference is a big deal for women with this severe of a FOD disorder. "Small changes are big for women."
The FDA requested asking the question as to whether the change in orgasm was a meaningful benefit; 47% of the 0.6mg group responded yes.
Stronger results in lower doses of Testosterone have been seen before, in males and in females. There is such a thing as a 'Goldilocks' dose - not too much, not too little but just right!
Dr. Bryson stated there was a strong skew to the Placebo data. Six women in the Placebo group (approx. 10%) achieved 48% of the orgasms in that group. Today's PR provides 'median' comparisons, far more meaningful than comparing simple averages and correcting the skew. The 0.6 mg Tefina median is 2 vs. 0 in the Placebo group and 1 in the 1.2 mg Tefina group. "The median is of central importance in robust statistics, as it is the most resistant statistic ... the median is the numerical value separating the higher half of a data sample from the lower half." (Wikipedia) With a median of zero in the Placebo group a % advantage for .6mg Tefina cannot be calulated.
Tefina was consistently better than Placebo in all areas and the difference steadily increased over the 84-day trial period. This suggests a longer study time will show an even greater difference between Tefina and Placebo.
The improvement in distress was 44% better for 0.6mg Tefina over Placebo and increased with time. Change in distress from baseline was significant p<0.001 (excellent).
Overall sexual activity was highest in the 0.6mg Tefina group.