Aim : Vardenafil is a selective and highly potent phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED), with improved selectivity for PDE5 and demonstrated efficacy for improving sexual function in men with ED. The current study investigated the safety and efficacy of this new PDE5 inhibitor in Japanese men with ED.Methods : This was a prospective, double blind, randomized clinical trial designed to evaluate the efficacy and safety of vardenafil. Following a 4-week treatment-free observation period, 283 eligible patients were randomized to 12 weeks treatment with vardenafil 5 mg, 10 mg, 20 mg, or placebo. Primary efficacy responses were assessed using the scores of Q3 and Q4 of the international index of erectile function (IIEF).Results : All three vardenafil doses showed significantly better improvement than the placebo group in Q3 and Q4 scores of the IIEF questionnaire, either at 12 weeks or at the 'last observation carried forward' (LOCF, P < 0.0001). Q3 scores were improved to 4.06 with vardenafil 5 mg, 4.53 with vardenafil 10 mg, and 4.64 with vardenafil 20 mg, versus 3.17 with placebo. Comparable scores for Q4 were 3.47, 4.15 and 4.31 versus 2.31 for placebo. Up to 86% of patients achieved improved erections as assessed by the global assessment question (GAQ). Reported adverse event rates were 35.3%, 45.3% and 54.5% with vardenafil 5 mg, 10 mg and 20 mg, respectively, versus 21.1% in the placebo group. No serious adverse drug reactions were reported. The most common treatment-emergent adverse events were transient headache, flushing and rhinitis, which were mostly mild. Conclusion : Vardenafil is an effective and well-tolerated treatment for ED and provides improvement in key indices of erectile function among Japanese men with ED. The results of our trial show that up to nearly 90% of patients achieve improved erections with the administration of vardenafil.
We have investigated the origin of the sperm motility inhibitor (SPMI) from boar seminal plasma. SPMI was measured by its capacity to inhibit the motility of demembranated spermatozoa and by an enzyme-linked immunosorbent assay (ELISA). Among the various reproductive and now reproductive tissues and fluids tested, only the seminal vesicle fluid and seminal plasma contained significant amounts of SPMI biological activity and SPMI antigen. Like other seminal vesicle fluid proteins, SPMI is diluted 6- to 8-fold upon ejaculation. By immunohistochemical detection at the light microscope with antibodies obtained from rabbits immunized with SPMI purified from boar seminal plasma, SPMI was found in the cytosol and/or on the plasma membrane bordering the lumen of the seminal vesicles. At the electron microscope level, SPMI appeared to be present only on the surface of the secretory cells. The data indicate that SPMI originates from a single tissue, the seminal vesicle, and suggest that only the mature form present on the luminal surface of the gland can react with the antibody generated from rabbits immunized with the secreted form of SPMI.
We evaluated fertility in fourteen patients after surgical repair of membranous urethral strictures associated with pelvic fractures. Eight patients were operated on using Badenoch's method (pull through) and six patients by end-to-end anastomosis of the urethra. All of them have maintained libido and potency after urethroplasty. No ejaculatory disturbance had ever occurred since surgery. Semen analysis was evaluated three months to four years after urethroplasty and serum hormone levels were measured in four patients. The results were as follows: 1) All except 2 patients had normal semen volume (more than 2 ml). 2) Nine patients (64%) had a sperm density of more than 40 x 10(6)/ml. Two patients had a sperm density of 20 to 40 x 10(6)/ml and three patients less than 20 x 10(6)/ml. 3) Nine patients (64%) had a sperm motility of more than 50%, three 30-50% and two less than 30%. 4) Seven patients (50%) had normal semen findings with a sperm density of more than 20 x 10(6)/ml and a sperm motility of more than 50% according to the WHO laboratory manual. 5) Pyospermia (WBC greater than or equal to 10/hpf) was observed in three patients. However, they never had subjective symptoms or objective findings of inflammation. 6) Serum LH, FSH, testosterone and PRL levels were within normal limits. 7) After urethroplasty, two patients married and their wives became pregnant. In conclusion, these results indicate that surgical repair of membranous urethral strictures associated with pelvic fractures has little effect on fertility.
An apparent pericentric inversion of the Y chromosome in a severely oligozoospermic infertile patient is described. The karyotype was 46,X,inv (Y) (p11.2 q11.23). DNA analysis, however, revealed a deletion involving nine loci within the most distal part of the euchromatic region of the long arm.
Boar semen contains a seminal plasma motility inhibitor (SPMI) that blocks the motility of demembranated-reactivated spermatozoa as well as of intact spermatozoa. In this paper, we describe the primary structure of SPMI, the coding of boar SPMI cDNA gene and its expression in various porcine tissues. Nucleotide sequence analysis of the 645-bp SPMI cDNA predicts a coded polypeptide of 137 amino acid residues which includes a 21-residue signal peptide and a ll6-residue secreted protein. The amino acid sequence of SPMI was found to be highly homologous to AQN-3, a member of spermadhesin family proteins of boar that bind to spermatozoa. Expression of the boar SPMI gene detected by Northern blot analysis revealed that its expression is very abundant in seminal vesicles and specific to this tissue.
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