Key Results

• The two diagnostic groups were similar in their response to TU. Although the numbers were too small, there was no indication that hypergonadotropic patients responded better than hypogonadotropic patients.

• Analysis of behavioral scores excluded the first-2-2 weeks of each treatment period in order to minimize the carryover effects of testosterone into the placebo period.

In all the sexual behavior variables, both those assessed by the investigator and those assessed by the patient, and self-rated (except subjective quality of sexual intercourse), there was a highly significant difference in favor of TU. The weekly number of sexual acts for all men increased from 0.8 in the no-treatment period to 2.1 with TU (placebo, 0.7). Similarly, the number of ejaculations per week increased from 0.3 with no treatment to 1.7 with TU (placebo, 0.2). Sexual interest (frequency of sexual thoughts and excitement) tended to increase within the first week of androgen replacement, and ejaculation started to return at 2 weeks. Testosterone concentrations measured at 0 hours, predose, and 4 hours, postdose, were significantly increased during TU treatment compared with the "no-treatment" levels. The postdose testosterone concentration was also highly significantly different from placebo at both 1 month and 2 months. However, this modest rise in testosterone concentrations did not reach normal range in 4 subjects.

Increases in 5 a-dihydrotestosterone concentrations were more substantial and significant at both 1 and 2 months after the start of TU treatment.

SHBG concentrations during TU administration showed a significant decrease compared with the placebo and no-treatment periods. Estradiol concentrations showed a small but significant rise, and there was no significant change in gonadotropin levels during TU treatment.

□ Testosterone undecanoate

□ Testosterone undecanoate

Very satisfactory

Satisfactory

Neutral

Unpleasant

Sexual acts * Ejaculations * Sexual Sexual thoughts * excitement *

Subjective quality of sexual acts

Figure 16.2. Treatment response (self-reported) to testosterone undecanoate in hypogonadai men compared with placebo (*significant for active treatment)

Sexual acts * Ejaculations * Sexual Sexual thoughts * excitement *

Very satisfactory

Subjective quality of sexual acts

Figure 16.2. Treatment response (self-reported) to testosterone undecanoate in hypogonadai men compared with placebo (*significant for active treatment)

Satisfactory

Neutral

Unpleasant

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