Figures & data
Table 1. Demographic characteristics of the subjects who completed the studies.
Table 2. Mean estrogen values in pharmacokinetic trials (geometric mean; baseline adjusted), and ANOVA results for comparisons between testTable Footnotea and referenceTable Footnoteb products. p Values indicate statistical significance at <0.05 between test and reference products.
Figure 1. Linear plot of baseline-corrected mean plasma concentration versus time for (a) estradiol (n = 34), (b) estrone (n = 33), and (c) estrone sulfate (n = 24) after treatment with the test and reference preparations, each at 10 μg. Test product: TX-004HR; TherapeuticsMD, Inc., Boca Raton, FL. Reference product: Vagifem®; Novo Nordisk, Plainsboro, NJ.
![Figure 1. Linear plot of baseline-corrected mean plasma concentration versus time for (a) estradiol (n = 34), (b) estrone (n = 33), and (c) estrone sulfate (n = 24) after treatment with the test and reference preparations, each at 10 μg. Test product: TX-004HR; TherapeuticsMD, Inc., Boca Raton, FL. Reference product: Vagifem®; Novo Nordisk, Plainsboro, NJ.](/cms/asset/2130761d-2ed7-4bce-ae32-636adb926952/icmt_a_1136926_f0001_c.jpg)
Figure 2. Linear plot of baseline-corrected mean plasma concentration versus time for (a) estradiol (n = 36), (b) estrone (n = 36), and (c) estrone sulfate (n = 36) after treatment with the test and reference preparations, each at 25 μg. Test product: TX-004HR; TherapeuticsMD, Inc., Boca Raton, FL. Reference product: Vagifem®; Novo Nordisk, Plainsboro, NJ.
![Figure 2. Linear plot of baseline-corrected mean plasma concentration versus time for (a) estradiol (n = 36), (b) estrone (n = 36), and (c) estrone sulfate (n = 36) after treatment with the test and reference preparations, each at 25 μg. Test product: TX-004HR; TherapeuticsMD, Inc., Boca Raton, FL. Reference product: Vagifem®; Novo Nordisk, Plainsboro, NJ.](/cms/asset/8390bba6-dae8-4a24-9333-62525ca254df/icmt_a_1136926_f0002_c.jpg)
Table 3. Statistical results of test product versus reference product for estrogens (baseline-adjusted).