| dc.description.abstract | This clinical research was a clinical trial; analytic, open-label, prospective
and logitudinal, which primary objective was to determine the effect of a
single dose of 50 mg of noretisterone enanthate (E-NET) and 5 mg of
estradiol valerate (VAL-E), in total testosterone (T) plasma concentrations
from 32 healthy male Mexican subjects. All volunteers received a singledose
of the combination on study day 0; blood samples were drawn on days
-2, -1, 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 18, 22, 26 and 30 days with the purpose
of measuring total testosterone plasma concentrations on days 0, 14, and
30; estradiol plasma concentrations on days -2, -1, and 0; and the
bioavailability of NET y E2 on every sample from days 0 to 30. The incidence
of adverse events was also registered. Total testosterone concentrations
before investigational product administration were (mean ± SD) 5.03 ± 1.30
ng/mL, these values were reduced to 0.61 ± 0.55 ng/mL 14 days after the
dose, and recovered to 3.75 ± 1.16 ng/mL for the day 30 of the study
(p<0.05). These values demonstrated that E-NET y VAL-E dose suppress T
plasma concentrations in this subjects.
Noretisterone pharmacokinetics parameters were
Cmáx=523.08±487.31pg/mL, AUC0-30d= 6459.95±2982.69 day*pg/mL,
tmáx=7.06±4.85 days and Ke=0.0461±0.0162. Estradiol pharmacokinetics
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parameters were: Cmáx= 368.31±146.74 pg/mL, AUC0-30d= 2,392.75±655.12
day*pg/mL, tmáx=2.5±1.16 days, Ke=0.1707±0.0774. Study subjects
presented 9 non-serious adverse events during the study, from which only
one had a relation (uncertain) to the investigational product. | |
