Semen quality of 1559 young men from four cities in Japan: a cross-sectional population-based study.

OBJECTIVES: To provide information of semen quality among normal young Japanese men and indicate the frequency of reduced semen quality. DESIGN: Cross-sectional, coordinated studies of Japanese young men included from university areas. The men had to be 18-24 years, and both the man and his mother had to be born in Japan. Background information was obtained from questionnaires. Standardised and quality-controlled semen analyses were performed, reproductive hormones analysed centrally and results adjusted for confounding factors. SETTING: Four study centres in Japan (Kawasaki, Osaka, Kanazawa and Nagasaki). PARTICIPANTS: 1559 men, median age 21.1 years, included during 1999-2003. OUTCOME MEASURES: Semen volume, sperm concentration, total sperm count, sperm motility, sperm morphology and reproductive hormone levels. RESULTS: Median sperm concentration was 59 (95% CI 52 to 68) million/ml, and 9% and 31.9% had less than 15 and 40 million/ml, respectively. Median percentage of morphologically normal spermatozoa was 9.6 (8.8 to 10.3)%. Small, but statistically significant, differences were detected for both semen and reproductive hormone variables between men from the four cities. Overall, the semen values were lower than those of a reference population of 792 fertile Japanese men. CONCLUSIONS: Assuming that the investigated men were representative for young Japanese men, a significant proportion of the population had suboptimal semen quality with reduced fertility potential, and as a group they had lower semen quality than fertile men. However, the definitive role-if any-of low semen quality for subfertility and low fertility rates remain to be investigated.

Profile of serum testosterone levels after application of testosterone ointment (glowmin) and its clinical efficacy in late-onset hypogonadism patients.

INTRODUCTION: Testosterone replacement therapy has been applied to alleviate the various symptoms of late-onset hypogonadism (LOH) patients. Several routes are available for the administration of testosterone to LOH patients, and transdermal delivery is an attractive method above all. AIM: The aim of this article was to clarify the profile of serum total testosterone (TT) and free testosterone (FT) levels after application of testosterone ointment (Glowmin [GL], Daito Pharmaceutical Co. Ltd., Tokyo, Japan) and its clinical efficacy in LOH patients. METHODS: Serum TT and FT levels were examined in healthy male volunteers and LOH patients after application of 3 mg of GL. Then, 50 LOH patients received 3 mg of GL twice daily on scrotal skin (6 mg/day) for 12 weeks. Subsequently, TT and FT levels immediately prior to GL application were compared with those at 1 hour after GL treatment. Furthermore, the clinical effects of GL in the aforementioned 50 LOH patients were estimated after 12 weeks of GL treatment. MAIN OUTCOME MEASURES: Hormonal effects of GL were evaluated by serum TT and FT levels. Aging males symptoms (AMS), international index of erectile function (IIEF-5), and MOS 36-item short form Healthy Survey (SF-36) questionnaire were used to assess the clinical efficacy of GL for LOH patients. RESULTS: Maximum TT and FT values, which were detected 1-2 hours after application of a 2-cm line of GL (3 mg of testosterone) to scrotal skin, were not elevated beyond physiological levels; subsequently, these levels returned to circadian rhythm after 4 hours in four healthy male volunteers. The highest TT and FT levels were also obtained after 1-2 hours in four LOH patients involving identical administration methods; moreover, these levels were maintained within a normal range for 6 hours. After 12 weeks of GL treatment in 50 LOH patients, TT and FT levels demonstrated the same satisfactory response as that of the initial GL administration without GL accumulation effects. GL accumulation after 1 week in healthy men and after 12 weeks in LOH patients was not observed. Furthermore, AMS score decreased markedly; IIEF-5 and four domains of the SF-36 score were elevated significantly following GL application. Severe adverse reactions were not observed. CONCLUSIONS: Accordingly, GL, which is a short-acting testosterone ointment eliciting physiological elevation of TT and FT, appears to be suitable for LOH treatment.

[The efficacy of testosterone ointment (Glowmin) treatment for late-onset-hypogonadism (LOH) patients according to LOH severity].

The most basic treatment for late-onset hypogonadism (LOH) is hormone replacment therapy (HRT). In Japan, intra-muscular injection of testosterone (T) has been used for LOH treatment as HRT. Testosterone ointment (Glowmin) has been available for HRT from 1965 as an over-the-counter drug, and the profile of serum T levels and efficacy of testosterone ointment for LOH patients has been reported. In this study, we analyzed the relationship between the efficacy of testosterone ointment and LOH severity. Fifty LOH patients were treated with 6 mg of testosterone ointment per day. After 12 weeks of treatment, they were divided into 2 groups according to the severity of their LOH, serum total T and free T levels, measured by such means as total aging males' symptoms (AMS) score. The improvements of total AMS score, international index of erectile function 5 score and MOS 36-Item Short-Form Health Survey (SF-36) score were observed and analysis of variation was performed. Results showed that the symptoms in the more severe patients had a total AMS score improvement in 4 domains, AMS (psychological), SF-36 body pain (BP), social function (SF), role-emotion, compared to patients with slight LOH. While patients with normal serum T levels felt BP improvement as opposed to patients with low serum T levels, there was no significant difference in the other domains. In conclusion, testosterone ointment is considered to be effective in improving several elements of AMS and SF-36 in patients with a high AMS score.

Hormone profiles after intramuscular injection of testosterone enanthate in patients with hypogonadism.

To examine hormone levels after androgen replacement therapy (ART) in Japanese male patients with hypogonadism, nine Japanese male patients with hypogonadism (serum total testosterone (tT) or free testosterone (fT) levels of < or = 2.7 ng/mL or < or = 10 pg/mL, respectively; average age, 59 years) were enrolled. They were treated with 125 mg of testosterone enanthate by single intramuscular injection. Blood samples were collected on the morning of the day of treatment, pre-ART, as well as on days 1 to 7 and day 14 after administration. Serum levels of tT, fT, estradiol (E2), follicle-stimulating hormone (FSH), luteinizing hormone (LH), and sex hormone-binding globulin (SHBG) were determined. On day 1 after administration, the mean serum levels of tT and fT were 7.62 ng/mL and 23.22 pg/mL, respectively. Serum levels of tT and fT on day 14 after administration were lower than their pre-ART values. One patient exhibited abnormally high serum tT and fT levels of 19.6 ng/mL and 44.4 pg/mL, respectively. Serum levels of LH and FSH began to decrease gradually on day 5 after administration. Serum levels of SHBG did not change throughout the observation period. Serum levels of E2 increased 1.7 times on day 1 after administration but returned to its pre-ART value by day 14 after administration. The dose of testosterone enanthate for male patients with hypogonadism requiring ART should be determined carefully because some patients exhibited high serum levels of androgen beyond the physiological range and gonadotropin was suppressed in all treated patients.

Relationships between erectile dysfunction, depression, and anxiety in Japanese subjects.

AIMS: This study aimed to elucidate the relationships between erectile dysfunction (ED) and depression or anxiety. METHODS: Subjects were 1,419 Japanese men aged 40-64 years. ED was assessed by the International Index of Erectile Function 5 (IIEF-5) score (Japanese version), and depression and anxiety symptoms were assessed by the Hospital Anxiety and Depression Scale (HADS). In this study ED cases were defined as those whose IIEF-5 value was less than 12, and a score of 8 or higher was used to classify a subject as suffering from depression or anxiety, respectively. The prevalence odds ratio (OR) of ED was calculated with confidence interval (CI) estimated by the Woolf's method by five age groups (40-44, 45-49, 50-54, 55-59, 60-64 years). To control for age, body mass index, smoking, and alcohol drinking factors, we conducted the multivariate logistic regression analysis for calculating adjusted ORs and 99% CIs. RESULTS: ED was significantly associated with depression in age groups 45-49 (OR 3.42, 99% CI 1.51-7.76) and 50-54 years (OR 2.43, 99% CI 1.11-5.35). After using multivariate analysis, adjusted OR also showed statistical significance. (OR 2.02, 99% CI 1.32-3.08). ED was significantly associated with anxiety in the 50-55-year-old age group (OR 2.48, 99% CI 1.12-5.47). After using multivariate analysis, adjusted OR also showed statistical significance (OR 1.77, 99% CI 1.15-2.72). The concomitant depression and anxiety group (A+D+) had significantly higher prevalence of ED than the control group (A-D-) in both the 45-49 and 50-54 age groups. (P < 0.01) CONCLUSION: ED associated significantly with depression and anxiety status only in late 40s to early 50s (45-55 years) in male Japanese. Furthermore, comorbidities of depression and anxiety strengthen this association. Our results might be useful in furthering understanding of ED etiology and determining a target population for prevention in ED subjects.

[Reference ranges of total serum and free testosterone in Japanese male adults].

PURPOSE: To establish reference range of serum Total Testosterone (T-T) and Free Testosterone (F-T) in Japanese male adults. SUBJECTS AND METHOD: Among 1,172 male adults, who daily lived their healthy life, 1,143 subjects in the year range from 20 to 77 years old, who had serum LH concentration within its reference range (For 20-70 years old: 1.1-25.9 mIU/mL), were selected. As diurnal rhythm of both T-T and F-T was observed, blood samples were collected in the morning when T-T and F-T concentration were relatively stable at their high concentration levels. The collected samples were stored at -20 degree C until they were used for assays. RESULTS: Reference range for T-T has decided to express by the mean +/- 2SD calculated from the entire test results, because influence of aging on the results was negligible, Reference range of T-T has established as 2.01-7.50 ng/mL. The other hand, reference ranges of F-T classified for every decade have decided to express by the mean +/- 2SD of each decade subgroup, because great influence of aging on F-T was observed. For each decade from 20 years on and > 70 years, reference ranges of F-T have established as: 8.5-27.9 pg/mL, 7.6-23.1 pg/mL, 7.7-21.6 pg/mL, 6.9-18.4 pg/mL, 5.4-16.7 pg/mL, and 4.5-13.8 pg/ mL, respectively. CONCLUSION: Reference ranges of serum T-T and F-T in Japanese male adults have established. And the value of Young Adult Mean (YAM) of F-T calculated for a group of the ages between 20 and 39 years have been proposed as a guideline of requirement for the Androgen Replacement Therapy (HRT). The value of 80% and 70% of YAM were 12.4 pg/mL and 10.9 pg/mL, respectively.