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Testosterone Restoration by Enclomiphene Citrate in Men with Secondary Hypogonadism: Pharmacodynamics and Pharmacokinetics.

Wiehle R, Cunningham GR, Pitteloud N, Wike J, Hsu K, Fontenot GK, Rosner M, Dwyer A, Podolski J - BJU Int. (2013)

Bottom Line: Enclomiphene and transdermal testosterone increased levels of TT within two weeks, but they had opposite effects on FSH and LH Treatment with enclomiphene did not significantly affect levels of TSH, ACTH, cortisol, lipids, or bone markers.Both transdermal testosterone and enclomiphene citrate decreased IGF-1 levels (p<0.05) but suppression was greater in the enclomiphene citrate groups.The effects on LH and TT persisted for at least one week after stopping treatment.

View Article: PubMed Central - PubMed

Affiliation: Repros Therapeutics Inc, Houston, TX.

No MeSH data available.


Related in: MedlinePlus

Effect of enclomiphene citrate on the pharmacodynamics of serum total testosterone compared with transdermal testosterone. The effects of various treatments are seen over 24-h period and compared between an initial dose and a dose given following 6 weeks of continuous treatment. Men with AIHH were treated with (A) transdermal testosterone according to label instructions initially (open triangles and dashed line) and after daily dosing (filled triangles and solid line); (B) enclomiphene citrate 6.25 mg initially (open diamonds and dashed line) and after daily oral dosing (filled diamond and solid line); (C) enclomiphene citrate 12.5 mg initially (open circles and dashed line) and after daily oral dosing (filled circles and solid line); and (D) enclomiphene citrate 25 mg initially (open squares and dashed line) and after daily oral dosing (filled squares and solid line). A second order polynomial is fitted to the data points and the R2 value is given next to the line. TT, total testosterone.
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fig01: Effect of enclomiphene citrate on the pharmacodynamics of serum total testosterone compared with transdermal testosterone. The effects of various treatments are seen over 24-h period and compared between an initial dose and a dose given following 6 weeks of continuous treatment. Men with AIHH were treated with (A) transdermal testosterone according to label instructions initially (open triangles and dashed line) and after daily dosing (filled triangles and solid line); (B) enclomiphene citrate 6.25 mg initially (open diamonds and dashed line) and after daily oral dosing (filled diamond and solid line); (C) enclomiphene citrate 12.5 mg initially (open circles and dashed line) and after daily oral dosing (filled circles and solid line); and (D) enclomiphene citrate 25 mg initially (open squares and dashed line) and after daily oral dosing (filled squares and solid line). A second order polynomial is fitted to the data points and the R2 value is given next to the line. TT, total testosterone.

Mentions: The results of the two 24-h pharmacodynamic studies provided useful comparisons between treatment with transdermal testosterone and enclomiphene citrate (Fig. 1). We observed an increase in concentration of testosterone in all treatment groups after 6 weeks of treatment in the PP population. On day 1 there were no differences between the groups in terms of mean CTT0h, or their average CTTmean, CmaxTT, CTTmin, or CTTrange values. On day 1 transdermal testosterone raised the CTTmean and CTTmax, although those increases were not significant among groups; probably because of the high variation in the mean values in the subjects who were treated with transdermal testosterone.


Testosterone Restoration by Enclomiphene Citrate in Men with Secondary Hypogonadism: Pharmacodynamics and Pharmacokinetics.

Wiehle R, Cunningham GR, Pitteloud N, Wike J, Hsu K, Fontenot GK, Rosner M, Dwyer A, Podolski J - BJU Int. (2013)

Effect of enclomiphene citrate on the pharmacodynamics of serum total testosterone compared with transdermal testosterone. The effects of various treatments are seen over 24-h period and compared between an initial dose and a dose given following 6 weeks of continuous treatment. Men with AIHH were treated with (A) transdermal testosterone according to label instructions initially (open triangles and dashed line) and after daily dosing (filled triangles and solid line); (B) enclomiphene citrate 6.25 mg initially (open diamonds and dashed line) and after daily oral dosing (filled diamond and solid line); (C) enclomiphene citrate 12.5 mg initially (open circles and dashed line) and after daily oral dosing (filled circles and solid line); and (D) enclomiphene citrate 25 mg initially (open squares and dashed line) and after daily oral dosing (filled squares and solid line). A second order polynomial is fitted to the data points and the R2 value is given next to the line. TT, total testosterone.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4155868&req=5

fig01: Effect of enclomiphene citrate on the pharmacodynamics of serum total testosterone compared with transdermal testosterone. The effects of various treatments are seen over 24-h period and compared between an initial dose and a dose given following 6 weeks of continuous treatment. Men with AIHH were treated with (A) transdermal testosterone according to label instructions initially (open triangles and dashed line) and after daily dosing (filled triangles and solid line); (B) enclomiphene citrate 6.25 mg initially (open diamonds and dashed line) and after daily oral dosing (filled diamond and solid line); (C) enclomiphene citrate 12.5 mg initially (open circles and dashed line) and after daily oral dosing (filled circles and solid line); and (D) enclomiphene citrate 25 mg initially (open squares and dashed line) and after daily oral dosing (filled squares and solid line). A second order polynomial is fitted to the data points and the R2 value is given next to the line. TT, total testosterone.
Mentions: The results of the two 24-h pharmacodynamic studies provided useful comparisons between treatment with transdermal testosterone and enclomiphene citrate (Fig. 1). We observed an increase in concentration of testosterone in all treatment groups after 6 weeks of treatment in the PP population. On day 1 there were no differences between the groups in terms of mean CTT0h, or their average CTTmean, CmaxTT, CTTmin, or CTTrange values. On day 1 transdermal testosterone raised the CTTmean and CTTmax, although those increases were not significant among groups; probably because of the high variation in the mean values in the subjects who were treated with transdermal testosterone.

Bottom Line: Enclomiphene and transdermal testosterone increased levels of TT within two weeks, but they had opposite effects on FSH and LH Treatment with enclomiphene did not significantly affect levels of TSH, ACTH, cortisol, lipids, or bone markers.Both transdermal testosterone and enclomiphene citrate decreased IGF-1 levels (p<0.05) but suppression was greater in the enclomiphene citrate groups.The effects on LH and TT persisted for at least one week after stopping treatment.

View Article: PubMed Central - PubMed

Affiliation: Repros Therapeutics Inc, Houston, TX.

No MeSH data available.


Related in: MedlinePlus