Introduction Addition of testosterone (T) may improve the action of phosphodiesterase type 5 inhibitors (PDE5-Is) in patients with erectile dysfunction not responding to PDE5-Is with low or low-normal T levels. Aims To confirm this add-on effect of T in men optimally treated with PDE5-Is and to specify the baseline T levels at which such an effect becomes significant. Methods A multicenter, multinational, double-blind, placebo-controlled study of 173 men, 45–80 years, nonresponders to treatment with different PDE5-Is, with baseline total T levels ≤4 ng/mL or bioavailable T ≤ 1 ng/mL. Men were first treated with tadalafil 10 mg once a day (OAD) for 4 weeks; if not successful, they were randomized in a double-blind, placebo-controlled design to receive placebo or a 1% hydroalcoholic T gel (50 mg/5 g gel), to be increased to 10 mg T if results were clinically unsatisfactory. Main Outcomes Measures Mean change from baseline in the Erectile Function Domain Score of the International Index of Erectile Function and rate of successful intercourses (Sexual Encounter Profile 3 question). Results Erectile function progressively improved over a period of at least 12 weeks in both the placebo and T treatment groups. In the overall population with a mean baseline T level of 3.37 ± 1.48 ng/mL, no additional effect of T administration to men optimally treated with PDE5-Is was encountered. The differences between the T and placebo groups were significant for both criteria only in the men with baseline T ≤3 ng/mL. Conclusions The maximal beneficial effects of OAD dosing with 10 mg tadalafil may occur only after as many as 12 weeks. Furthermore, addition of T to this PDE5-I regimen is beneficial, but only in hypogonadal men with baseline T levels ≤3 ng/mL.
Aim To analyze behaviors, mental perception, satisfaction, and expectations relating to sexuality in France. Methods A total of 1,002 subjects (483 men and 519 women) aged 35 years and over in a representative sample of the French population were surveyed by phone using a dedicated questionnaire in November 2003. Main Outcome Measures Sexual behaviors and mental perception, satisfaction and expectations concerning sexual life. Results Of the population, 80.2% reported having a sexual partner. The mean number of times subjects had sex per week was 1.8 (2.0 in men, 1.6 in women). The decision preceded the act by a few seconds or minutes in 82.7% of subjects. Thinking about sex was “frequent” in 47.1% of subjects, especially for men (60.8%). Regardless of gender, sexuality was more synonymous with pleasure (44.0%) and love (42.1%) than with procreation, children, or motherhood (7.8%). During sexual intercourse, simultaneous orgasms and feelings of closeness were important for the majority of subjects, 35.8% (41.6% of men) and 22.8%, respectively; foreplay, enjoyment, and vaginal penetration were the most important accomplishments for 13.1%. Regardless of gender, 83.0% of subjects expressed relative or full satisfaction with their sex life. However, only 38.7% of subjects (31.6% of men and 45.2% of women) did not wish to change anything, while 17.2% would like to have more time for it. Of the subjects, 63.0% reported a decrease in sexual desire during periods of work-related stress, especially in women (72.3%). The main sexual complaints reported by men were diminution of sexual desire (24.9%), early ejaculation (23.7%), and erectile problems (14.4%). In women, they were diminution of sexual desire (45.7%), orgasm disorders (15.5%), and dyspareunia (15.5%). Conclusions This survey showed that the attitude of subjects, especially men, toward sexuality is changing through years and highlighted the extent of sexual problems in the general population.
We assessed the efficiency and tolerance of the alpha-blocking agent moxisylyte in 2 double-blind studies versus placebo performed in 12 neurogenic patients with spinal cord lesions and in 61 patients presenting with either psychogenic impotence (30) or erectile dysfunction that was predominantly neither psychogenic, hormonal nor neurogenic (31). In each etiological group patients were randomized (according to latin square method) to receive 3 single doses (10, 20 and 30 mg.) of moxisylyte and a placebo. The erectile response was determined 5, 10, 15, 20 and 30 minutes after each injection. Whatever etiology of impotence and dosage tested, the erectile response induced by moxisylyte was significantly higher than the placebo-induced response. No difference occurred among the 3 doses. In 93% of the patients moxisylyte induced an erectile response, including tumescence in 6, partial rigidity in 16 and complete rigidity in 46. Thus, in 62 of 73 patients (85%) the drug allowed initiation of erection adequate for intercourse. Placebo induced such erection in only 25% of the cases and in 55% there was no response. Tolerance was good and no priapism occurred. Only 4 patients (5%) reported mild pain during injection but erections were never painful, 1 presented with moderate and transient hypotension at the 20 mg. dose and a painless prolonged erection was observed in 1 case after the lowest dose. Drugs such as moxisylyte should be given before less well tolerated drugs.
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