Active substance: Clomiphene
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This article has been cited by other articles in PMC. Abstract Objectives To determine the pharmacodynamic profile of serum total testosterone and luteinizing hormone LH levels in men with secondary hypogonadism after initial and chronic daily oral doses of enclomiphene citrate vs transdermal testosterone.
To determine the effects of daily oral doses of enclomiphene citrate in comparison with transdermal testosterone on other hormones and markers in men with secondary hypogonadism.
Patients and Methods This was a randomized, single-blind, two-centre, phase II study to evaluate the effects of three different doses of enclomiphene citrate 6.
Forty-four men completed the study per protocol. Total testosterone and LH levels were assessed each hour for 24 h to examine the effects at each of three treatment doses of enclomiphene citrate vs a standard dose 5 g of transdermal testosterone.
This was contrasted to that seen after 6 weeks of continuous daily oral or transdermal treatment day 42.
The pharmacokinetics of enclomiphene citrate were assessed in a select subpopulation.
Serum samples were obtained over the course of the study to determine the levels of various hormones and lipids. All three doses of enclomiphene citrate increased the testosterone concentration at time 0 of each 24-h sampling period, and the mean, maximum, minimum and range of testosterone concentrations over the 24-h sampling period.
Transdermal testosterone also raised total testosterone, albeit with more variability, and with suppressed LH levels.
The patterns of total testosterone over the 24-h period after 6 weeks of dosing could be fit to a nonlinear function with morning elevations, mid-day troughs, and rising night-time levels.
Enclomiphene citrate and transdermal testosterone increased levels of total testosterone within 2 weeks, but they had opposite effects on FSH and LH.
Treatment with enclomiphene citrate did not significantly affect levels of thyroid-stimulating hormone, adenocorticotropic hormone, cortisol, lipids or bone markers.
Conclusions Enclomiphene citrate increased serum LH and total testosterone; however, there was not a temporal association between the peak drug levels and the maximum concentration levels of LH or total testosterone.
Enclomiphene citrate consistently increased serum total testosterone into the normal range and increased LH and FSH above the normal range.