title: Characteristics associated with suppression of spermatogenesis in a male hormonal contraceptive trial using testosterone and Nestorone(®) gels.
abstract: Development of a male hormonal contraceptive has been challenging ascribable to the failure to adequately suppress spermatogenesis in 5-10% of men. Methods to identify incomplete suppressors early in treatment might identify men most responsive to male hormonal contraceptives. We hypothesized that serum hormone and gonadotropin concentrations after 4 weeks of transdermal treatment with testosterone and Nestorone in a contraceptive trial would be associated with suppression of sperm concentrations to <1 million/mL after 24 weeks. Indeed, luteinizing hormone or follicle-stimulating hormone concentrations greater than 1 IU/L after 4 weeks of transdermal testosterone/nestorone treatment were 97% sensitive for predicting failure to suppress spermatogenesis after 24 weeks of treatment. Serum nestorone concentrations were significantly associated with suppression, but serum testosterone concentrations were not. Early suppression of gonadotropins is associated with, but does not ensure, adequate suppression of spermatogenesis. This information may allow for rapid identification of non-responders in male hormonal contraceptive trials.
authors.affiliation: Department of Internal Medicine, University of Washington, Seattle, WA, USA.
authors.forename: M Y
authors.initials: MY
authors.lastname: Roth
authors.affiliation: Division of Endocrinology, Department of Medicine, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.
authors.forename: N
authors.initials: N
authors.lastname: Ilani
authors.affiliation: Division of Endocrinology, Department of Medicine, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.
authors.forename: C
authors.initials: C
authors.lastname: Wang
authors.affiliation: Department of Internal Medicine, University of Washington, Seattle, WA, USA.
authors.forename: S T
authors.initials: ST
authors.lastname: Page
authors.affiliation: Department of Internal Medicine, University of Washington, Seattle, WA, USA.
authors.forename: W J
authors.initials: WJ
authors.lastname: Bremner
authors.affiliation: Division of Endocrinology, Department of Medicine, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.
authors.forename: R S
authors.initials: RS
authors.lastname: Swerdloff
authors.affiliation: Health Decisions, Durham, NC, USA.
authors.forename: C
authors.initials: C
authors.lastname: Dart
authors.affiliation: Center for Biomedical Research, Population Council, New York, NY, USA.
authors.forename: R
authors.initials: R
authors.lastname: Sitruk-Ware
authors.affiliation: Center for Biomedical Research, Population Council, New York, NY, USA.
authors.forename: N
authors.initials: N
authors.lastname: Kumar
authors.affiliation: Contraception and Reproductive Health Branch, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.
authors.forename: D
authors.initials: D
authors.lastname: Blithe
authors.affiliation: Department of Internal Medicine, University of Washington, Seattle, WA, USA.
authors.forename: J K
authors.initials: JK
authors.lastname: Amory
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D003272:Contraceptive Agents, Male / Q000494:pharmacology; D005640:Follicle Stimulating Hormone / Q000097:blood; D005782:Gels; D006801:Humans; D007986:Luteinizing Hormone / Q000097:blood; D008297:Male; D008875:Middle Aged; D009653:Norprogesterones / Q000008:administration & dosage / Q000097:blood / Q000494:pharmacology*; D013091:Spermatogenesis / Q000187:drug effects; D013739:Testosterone / Q000008:administration & dosage / Q000097:blood / Q000494:pharmacology
chemical_list: D003272:Contraceptive Agents, Male; D005782:Gels; D009653:Norprogesterones; D013739:Testosterone; C029167:ST 1435; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone
keywords: contraception; gonadotropins; nestorone; spermatogenesis; testosterone