Dean Destructo
New member
[h=4]CONTEXT:[/h]<abstracttext label="CONTEXT" nlmcategory="BACKGROUND">Combinations of testosterone (T) and nestorone (NES; a nonandrogenic progestin) transdermal gels may suppress spermatogenesis and prove appealing to men for contraception.</abstracttext>
[h=4]OBJECTIVE:[/h]<abstracttext label="OBJECTIVE" nlmcategory="OBJECTIVE">The objective of the study was to determine the effectiveness of T gel alone or combined with NES gel in suppressing spermatogenesis.</abstracttext>
[h=4]DESIGN AND SETTING:[/h]<abstracttext label="DESIGN AND SETTING" nlmcategory="METHODS">This was a randomized, double-blind, comparator clinical trial conducted at two academic medical centers.</abstracttext>
[h=4]PARTICIPANTS:[/h]<abstracttext label="PARTICIPANTS" nlmcategory="METHODS">Ninety-nine healthy male volunteers participated in the study.</abstracttext>
[h=4]INTERVENTIONS:[/h]<abstracttext label="INTERVENTIONS" nlmcategory="METHODS">Volunteers were randomized to one of three treatment groups applying daily transdermal gels (group 1: T gel 10 g+NES 0 mg/placebo gel; group 2: T gel 10 g+NES gel 8 mg; group 3: T gel 10 g+NES gel 12 mg).</abstracttext>
[h=4]MAIN OUTCOME VARIABLE:[/h]<abstracttext label="MAIN OUTCOME VARIABLE" nlmcategory="METHODS">The main outcome variable of the study was the percentage of men whose sperm concentration was suppressed to 1 million/ml or less by 20-24 wk of treatment.</abstracttext>
[h=4]RESULTS:[/h]<abstracttext label="RESULTS" nlmcategory="RESULTS">Efficacy data analyses were performed on 56 subjects who adhered to the protocol and completed at least 20 wk of treatment. The percentage of men whose sperm concentration was 1 million/ml or less was significantly higher for T+NES 8 mg (89%, P<0.0001) and T+NES 12 mg (88%, P=0.0002) compared with T+NES 0 mg group (23%). The median serum total and free T concentrations in all groups were maintained within the adult male range throughout the treatment period. Adverse effects were minimal in all groups.</abstracttext>
[h=4]CONCLUSION:[/h]<abstracttext label="CONCLUSION" nlmcategory="CONCLUSIONS">A combination of daily NES+T gels suppressed sperm concentration to 1 million/ml or less in 88.5% of men, with minimal adverse effects, and may be further studied as a male transdermal hormonal contraceptive.</abstracttext>
[h=4]OBJECTIVE:[/h]<abstracttext label="OBJECTIVE" nlmcategory="OBJECTIVE">The objective of the study was to determine the effectiveness of T gel alone or combined with NES gel in suppressing spermatogenesis.</abstracttext>
[h=4]DESIGN AND SETTING:[/h]<abstracttext label="DESIGN AND SETTING" nlmcategory="METHODS">This was a randomized, double-blind, comparator clinical trial conducted at two academic medical centers.</abstracttext>
[h=4]PARTICIPANTS:[/h]<abstracttext label="PARTICIPANTS" nlmcategory="METHODS">Ninety-nine healthy male volunteers participated in the study.</abstracttext>
[h=4]INTERVENTIONS:[/h]<abstracttext label="INTERVENTIONS" nlmcategory="METHODS">Volunteers were randomized to one of three treatment groups applying daily transdermal gels (group 1: T gel 10 g+NES 0 mg/placebo gel; group 2: T gel 10 g+NES gel 8 mg; group 3: T gel 10 g+NES gel 12 mg).</abstracttext>
[h=4]MAIN OUTCOME VARIABLE:[/h]<abstracttext label="MAIN OUTCOME VARIABLE" nlmcategory="METHODS">The main outcome variable of the study was the percentage of men whose sperm concentration was suppressed to 1 million/ml or less by 20-24 wk of treatment.</abstracttext>
[h=4]RESULTS:[/h]<abstracttext label="RESULTS" nlmcategory="RESULTS">Efficacy data analyses were performed on 56 subjects who adhered to the protocol and completed at least 20 wk of treatment. The percentage of men whose sperm concentration was 1 million/ml or less was significantly higher for T+NES 8 mg (89%, P<0.0001) and T+NES 12 mg (88%, P=0.0002) compared with T+NES 0 mg group (23%). The median serum total and free T concentrations in all groups were maintained within the adult male range throughout the treatment period. Adverse effects were minimal in all groups.</abstracttext>
[h=4]CONCLUSION:[/h]<abstracttext label="CONCLUSION" nlmcategory="CONCLUSIONS">A combination of daily NES+T gels suppressed sperm concentration to 1 million/ml or less in 88.5% of men, with minimal adverse effects, and may be further studied as a male transdermal hormonal contraceptive.</abstracttext>
