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Submitted on August 3, 2005
Accepted on November 1, 2005
Division of Endocrinology, Department of Medicine, Obstetrics & Gynecology, Pediatrics, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California 90509, USA (CW, AN, KKL, NB, LL, AL, LH, SD, RSS), Jiangsu Family Planning Research Institute (XHW, JST), and the First Affiliated Hospital, Nanjing Medical University (YGC), Nanjing, Jiangsu 210036, China
* To whom correspondence should be addressed. E-mail: wang{at}labiomed.org.
Context: Previous male contraceptive studies showed that progestins enhance spermatogenesis suppression by androgens in men.
Objective: We compared the efficacy of spermatogenesis suppression by combination of levonorgestrel (LNG) with testosterone (T) implants to T implants alone in two different ethnic groups.
Design: Randomized trial in two centers with two treatment groups.
Settings: Academic Medical Center in the United States and Research Institute in China.
Participants: 40 non-Chinese and 40 Chinese healthy male volunteers.
Interventions: Subjects were randomized to receive four LNG implants together with four T implants (inserted on day 1 and week 15-18) vs. T implants alone for 30 weeks.
Main Outcome Measures: The primary endpoint compared the efficiency of suppression to severe oligozoospermia (1 x 106/ml) by LNG plus T implants vs. T implants alone. The secondary endpoint examined differences in spermatogenesis suppression between Chinese and non-Chinese subjects.
Results: LNG plus T implants caused more suppression of spermatogenesis to severe oligozoospermia in treatment period than T implants alone at both sites (P < 0.02). In Chinese men, severe oligozoospermia was achieved in over 90% of men in both treatment groups. Suppression to severe oligozoospermia was less in the non-Chinese men (59%) after T alone (P < 0.020); this difference disappeared with combined treatment (89%). T implant extrusion occurred in six men. Acne and increased hemoglobin were the most common adverse events.
Conclusion: T implants resulted in more pronounced spermatogenesis suppression in Chinese men. Addition of LNG implants to T implants enhanced the suppression of spermatogenesis in the treatment period in both Chinese and non-Chinese men.
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