Active Ingredient: Clomiphene
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Capsules were supplied by Repros Therapeutics.
Subjects receiving enclomiphene citrate were instructed to take one capsule of blinded study medication between 7:00 h and 10:00 h every day. Transdermal testosterone was applied as per the package insert.
Subjects were instructed to apply the gel at the same time each day, and not to bathe or swim for 3—4 h after application.
At visit 1 or week 2 subjects underwent screening procedures, which included signing of the consent form, a complete medical history, medication history, physical examination, blood evaluation and a slit lamp eye examination and visual acuity test.
Eligible subjects underwent a 24-h assessment of baseline total testosterone, LH and FSH visit 2 or week 0.
Blood samples were also collected to test for lipids and hormones and subjects were asked to follow a normal ad libitum diet. Subjects received a study medication kit, containing a 2-week supply of study medication.
Subjects in the enclomiphene citrate arms returned for visits at 2 and 4 weeks in the morning before 09:00 h for blood draws before 10:00 h to measure total testosterone, FSH, LH and trough levels of the study drug. At 6 weeks, subjects underwent a 24-h assessment of total testosterone and LH.
During this time blood was also drawn for a pharmacokinetic assessment of serum enclomiphene citrate levels at 0, 2, 4, 8, 12, 16 and 24 h after a single dose of enclomiphene citrate 6.
Subjects returned at 7 weeks for a final blood draw after a 1-week washout before 10:00 h. Statistical Analysis Statistical analysis of the primary efficacy variable was the change between day 1 and day 42 in the 24-h mean testosterone and LH levels.
An overall comparison among the four treatment groups was performed using anova or the Kruskal—Wallis test. The secondary efficacy variables were the changes in total testosterone, LH and FSH over the course of the study.
Changes in lipids and other hormones were assessed between the baseline and week 6.
An analysis of pharmacokinetics for the enclomiphene citrate arms also was performed based on enclomiphene citrate concentrations in serum at 0,2, 4, 12, 16 and 24 h drawn during week 6.
Summaries for quantitative variables include the sample size and the mean, median, sd, minimum and maximum values.
Summaries for categorical variables include the number and percent of patients for each outcome. A regression analysis was conducted to determine whether morning testosterone was predictive of the mean, minimum and maximum concentrations of total testosterone CTTmean, CTTmin and CTTmax, respectively at various time points.
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