Session: SUN 524-553-Male Reproductive Endocrinology
Bench to Bedside
Poster Board SUN-549
Objective: To determine if serum hormones and/or gonadotropin measurements in men, after receiving 4 weeks of a gel-based male hormonal contraceptive regimen, can predict the suppression of sperm concentrations to <1 million/ml at 24 weeks.
Methods: Analysis of serum hormone and gonadotropin concentrations in 99 healthy men enrolled in a randomized, double-blind, clinical trial conducted at two academic medical centers.
Intervention: Subjects were randomized to one of three groups for 24 weeks of daily application with either: 1%Testosterone gel 10 gm + placebo gel, 1% Testosterone gel 10 gm + NestoroneTM gel 8 mg, 1% Testosterone gel 10 gm + NestoroneTM gel 12 mg.
Analysis: Analysis included data pooled from all 3 study groups and groups specifically receiving active NestoroneTM gel. Logistic and linear regression models were used to identify significant early predictors of failure to adequately suppress spermatogenesis after 24 weeks of treatment.
Results: A luteinizing hormone (LH) or follicle-stimulating hormone (FSH) of greater than 1 IU/L after 4 weeks of transdermal testosterone/NestoroneTM treatment was 97% sensitive for failure to suppress spermatogenesis after 24 weeks of treatment. However, LH and FSH concentrations of <1 IU/L at 4 weeks are not highly specific for suppression of spermatogenesis. Serum testosterone concentrations were not significantly associated with suppression of spermatogenesis, but serum NestoroneTM concentrations above a threshold limit were significantly associated with suppression at every time point.
Conclusion: After 4 weeks of treatment with a transdermal androgen/progestin male hormonal contraceptive regimen, serum gonadotropin concentrations > 1 IU/ml were highly sensitive for failure to achieve suppression of spermatogenesis at week 24. Compliance of the user may be a significant factor in failure to suppress. Early suppression of gonadotropins is predictive of, but does not ensure, adequate suppression of spermatogenesis. In addition, serum NestoroneTM concentrations above a minimum threshold level were associated with suppression of spermatogenesis. This information may be useful in the development of male hormonal contraceptive regimens to consider altering the participation of men whose serum gonadotropins are not suppressed after 4 weeks of treatment.
Nothing to Disclose: MYR, NI, CCW, STP, JJSN, WJB, RSS, CD, RS, NK, DLB, JW, JKA
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