OBJECTIVE: To evaluate the secondary impact of a prototype androgen contraceptive regimen on physical, metabolic and behavioral variables. DESIGN: Prospective, open, noncomparative contraceptive efficacy study. SETTING: International multicenter study comprising 10 centers in seven countries. SUBJECTS: Two hundred seventy-one healthy men, age 31.8 +/- 5.4 years (mean +/- SD), range 21 to 45 years. INTERVENTIONS: Weekly IM injections of 200 mg T enanthate. MAIN OUTCOME MEASURES: Adverse effects and discontinuations; biochemical and hematologic changes and interpopulation differences. RESULTS: Chinese subjects were shorter and lighter and their baseline hemoglobin, plasma lipid, and liver enzyme levels were lower than in non-Chinese subjects. The most common side effects were painful injections, acne, fatigue, and weight gain. Gynecomastia and prostate problems were detected in 24 and 9 men, respectively, though no men stopped injections for such reasons. Testosterone enanthate increased body weight, hemoglobin, and urea but decreased testicular volume and creatinine. Plasma triglyceride, cholesterol, and low-density lipoprotein cholesterol were unchanged; high-density lipoprotein cholesterol decreased by 14% to 18% in non-Chinese but was unchanged in Chinese men. Liver transaminases were increased by 36% to 51% in Chinese but were unchanged in non-Chinese subjects. These T enanthate-induced effects were reversible within 6 months of stopping injections and were not related to the duration of T exposure. CONCLUSIONS: Testosterone enanthate administration in a contraceptive trial produced significant but reversible effects on skin, muscle, liver, lipid metabolism, and hemopoietic functions that varied between population groups. These effects reflect the relatively high peak levels and fluctuations of plasma T produced by the weekly T enanthate regimen rather than an inherent feature of hormonal male contraception. The results highlight the need for long-acting preparations of T with more stable delivery kinetics.
OBJECTIVE: To evaluate the secondary impact of a prototype androgen contraceptive regimen on physical, metabolic and behavioral variables. DESIGN: Prospective, open, noncomparative contraceptive efficacy study. SETTING: International multicenter study comprising 10 centers in seven countries. SUBJECTS: Two hundred seventy-one healthy men, age 31.8 +/- 5.4 years (mean +/- SD), range 21 to 45 years. INTERVENTIONS: Weekly IM injections of 200 mg T enanthate. MAIN OUTCOME MEASURES: Adverse effects and discontinuations; biochemical and hematologic changes and interpopulation differences. RESULTS: Chinese subjects were shorter and lighter and their baseline hemoglobin, plasma lipid, and liver enzyme levels were lower than in non-Chinese subjects. The most common side effects were painful injections, acne, fatigue, and weight gain. Gynecomastia and prostate problems were detected in 24 and 9 men, respectively, though no men stopped injections for such reasons. Testosterone enanthate increased body weight, hemoglobin, and urea but decreased testicular volume and creatinine. Plasma triglyceride, cholesterol, and low-density lipoprotein cholesterol were unchanged; high-density lipoprotein cholesterol decreased by 14% to 18% in non-Chinese but was unchanged in Chinese men. Liver transaminases were increased by 36% to 51% in Chinese but were unchanged in non-Chinese subjects. These T enanthate-induced effects were reversible within 6 months of stopping injections and were not related to the duration of T exposure. CONCLUSIONS:Testosterone enanthate administration in a contraceptive trial produced significant but reversible effects on skin, muscle, liver, lipid metabolism, and hemopoietic functions that varied between population groups. These effects reflect the relatively high peak levels and fluctuations of plasma T produced by the weekly T enanthate regimen rather than an inherent feature of hormonal male contraception. The results highlight the need for long-acting preparations of T with more stable delivery kinetics.
Entities:
Keywords:
Americas; Androgens; Asia; Australia; Biology; Body Weight--changes; China; Clinical Research; Clinical Trials; Contraception; Contraceptive Agents; Contraceptive Agents, Male; Developed Countries; Developing Countries; Eastern Asia; Endocrine System; Enzymatic Effects; Enzymes And Enzyme Inhibitors; Europe; Family Planning; Finland; France; Health; Hormones; Mediterranean Countries; Metabolic Effects; North America; Northern America; Northern Europe; Oceania; Physiology; Public Health; Research Methodology; Research Report; Safety; Scandinavia; Sweden; Testosterone--pharmacodynamics; Testosterone--side effects; United Kingdom; United States; Western Europe
Authors: John K Amory; Charles H Muller; Jakob A Shimshoni; Nina Isoherranen; Jisun Paik; Jan S Moreb; David W Amory; Ryan Evanoff; Alex S Goldstein; Michael D Griswold Journal: J Androl Date: 2010-08-12
Authors: M Y Roth; J J S Nya-Ngatchou; K Lin; S T Page; B D Anawalt; A M Matsumoto; B T Marck; W J Bremner; J K Amory Journal: J Clin Endocrinol Metab Date: 2013-01-24 Impact factor: 5.958
Authors: Fiona Yuen; Brian T Nguyen; Ronald S Swerdloff; Christina Wang Journal: Best Pract Res Clin Obstet Gynaecol Date: 2020-02-19 Impact factor: 5.237
Authors: Fiona Yuen; Arthi Thirumalai; Cindy Pham; Ronald S Swerdloff; Bradley D Anawalt; Peter Y Liu; John K Amory; William J Bremner; Clint Dart; Hongsheng Wu; Laura Hull; Diana L Blithe; Jill Long; Christina Wang; Stephanie T Page Journal: J Clin Endocrinol Metab Date: 2020-03-01 Impact factor: 5.958