[SUN-65] A New Combination of Testosterone and Nestorone® Transdermal Gels for Male Hormonal Contraception

Niloufar Ilani, Mara Y Roth, John K Amory, Ronald S Swerdloff, Clint Dart, Stephanie T Page, William J Bremner, Regine Sitruk-Ware, Narender Kumar, Diana Blithe, Christine Wang. Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA; University of Washington, Seattle, WA; Agile Clinical Development, Durham, NC; Population Council, New York, NY; National Institutes of Health, Bethesda, MD.

Context: Combinations of testosterone (T) and progestin transdermal gels enhance the suppression of spermatogenesis and prove effective and appealing to a majority of men for contraception. Provider-independent application of this regimen may increase acceptability and compliance among users.
Objective: To determine the effectiveness of T gel alone or combined with Nestorone (NES), a potent non-androgenic progestin, in gel formulation for suppressing spermatogenesis.
Design and Setting: Randomized, double-blind, comparator clinical trial conducted at two academic medical centers.
Participants: 99 healthy male volunteers.
Interventions: Men were randomized to one of three treatment groups applying daily transdermal gels (Group 1: T 10g + NES 0mg/placebo gel; Group 2: T 10g + NES 8mg; Group 3: T gel 10g + NES 12mg).
Outcome Variables: 1) Percentage of men who reached a sperm concentration of ≤1 million/ml by 20-24 weeks of treatment. 2) The impact of each treatment on gonadotropins, sperm morphology and motility.
Results: Efficacy data analyses were performed on 56 subjects who adhered to the protocol and completed at least 20 weeks of treatment. The percentage of men with sperm concentration of ≤1 million/ml was significantly higher for T+NES 8 mg (89%, P <0.0001) and T+NES 12 mg (88%, P <0.0002) than T alone group (23%). In addition, significantly more men became azoospermic in the T+NES 8 (78%, P <0.001) and T+NES 12 (69%, P <0.008) groups compared to T+NES 0 (23%). The decrease in sperm motility and normal morphology followed the decrease in sperm concentration. Median serum luteinizing hormone and follicular stimulating hormone concentrations were more suppressed in the groups receiving NES together with T. Median total and free T concentrations remained within the adult male range irrespective of treatment group. All subjects recovered to a sperm concentration of ≥15 million/ml during the recovery period. Adverse effects were minimal in all groups.
Conclusion: A combination of daily NES+T gels suppressed sperm concentration to ≤1 million/ml in the majority of men with minimal adverse effects. The results warrant further investigation of this combined male transdermal hormonal contraceptive regimen.

Sources of Research Support: NICHD Grant HHSN275200403369I, HHSN2751008060044U and the Population Council. The Los Angeles center was supported by: Endocrinology, Metabolism and Nutrition training Grant (T32 DK007571); General Clinical Research Center (MO1 RR00425) and the UCLA Clinical and Translational Science Institute (1UL1-RR033176) at Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute. The Seattle center was supported by: Eunice Kennedy Shriver NICHD Grant HHSN27520040337; Center for Research in Reproduction and Contraception U54 HD 04245 (NICHD); and Eunice Kennedy Shriver NICHD 5K12HD053984.

Nothing to Disclose: NI, MYR, JKA, RSS, CD, STP, WJB, RS-W, NK, DB, CW

Date: Sunday, June 24, 2012
Session Info: POSTER SESSION: Male Reproductive Endocrinology (1:30 PM-3:30 PM)
Presentation Time: 1:30 pm
Room: Expo

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