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Male Hormonal Contraception: Suppression of Spermatogenesis by Injectable Testosterone Undecanoate Alone Or with Levonorgestrel Implants in Chinese Men

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Male Hormonal Contraception: Suppression of Spermatogenesis by Injectable Testosterone Undecanoate Alone Or with Levonorgestrel Implants in Chinese Men Journal of Andrology, Vol. 25, No. 5, September/October 2004 Copyright q American Society of Andrology Male Hormonal Contraception: Suppression of Spermatogenesis by Injectable Testosterone Undecanoate Alone or With Levonorgestrel Implants in Chinese Men YOU-LUN GUI,* CHANG-HAI HE,* JOHN K. AMORY,² WILLIAM J. BREMNER,² E-XIANG ZHENG,* JIE YANG,* PEI-JUAN YANG,* AND ER-SHENG GAO* From the *Shanghai Institute of Planned Parenthood Research, Shanghai, China; and the ²Department of Medicine, University of Washington, Seattle, Washington. ABSTRACT: Monthly injections of testosterone undecanoate (TU) act follicle-stimulating hormone, and LNG were measured every 2 weeks as a male contraceptive by reversibly suppressing spermatogenesis before, during, and after treatment. During treatment, group II dem- to azoospermia or severe oligoazoospermia in 95% of Chinese men. onstrated a trend toward a greater attainment of azoospermia than In 5% of Chinese men, however, monthly TU administered alone fails groups I and III (90% vs 62% [group I] vs 67% [group III]; P 5 .09). to suppress spermatogenesis into contraceptive ranges, or sperm ``re- Attainments of either azoospermia or oligozoospermia (sperm density, bound,'' leading to occurrences of pregnancy during treatment. Since ,3 3 106/mL) were 95%, 100%, and 86% for groups I, II, and III, combinations of progestins and androgens are associated with greater respectively (P . .05 for comparisons between groups). Spermato- degrees of sperm suppression in white men, we hypothesized that the genesis in all subjects returned to the normal range after the implants combination of TU and the progestin levonorgestrel (LNG) would re- were removed. No serious adverse events and no signi®cant changes sult in improved spermatogenic suppression in Chinese men. Sixty- in serum chemistry occurred during the study. These results demon- two healthy Chinese men were randomly assigned to one of the fol- strate that the combination of IM injections of high-dose TU every 2 lowing 3 regimens: group I (n 5 21) received 4 LNG rods (75 mg months and LNG implants is associated with marked suppression of each), which were followed 4 weeks later by 500 mg of TU by intra- spermatogenesis in Chinese men. The combination of high-dose TU muscular (IM) injection every 8 weeks for 24 weeks; group II (n 5 20) every 2 months and LNG implants is a promising candidate for future received 4 LNG implants, which were followed 4 weeks later by 1000 large-scale ef®cacy studies of hormonal male contraception in Chi- mg of TU by IM injection every 8 weeks for 24 weeks; and group III nese men. (n 5 21) received TU 1000 mg by IM injection every 8 weeks for 24 Key words: Androgens, contraceptive, progestins, family planning. weeks. Sperm counts, serum testosterone (T), luteinizing hormone, J Androl 2004;25:720±727 fforts to develop a safe, reversible hormonal contra- for hormonal contraception in Chinese men, and previous Eceptive for men have used the administration of ex- small studies of Chinese men have reported high degrees ogenous testosterone (T) to inhibit the secretion of pitu- of azoospermia with T-alone regimens (Zhang et al, itary gonadotropins and thereby suppress spermatogenesis 1999). However, recently, a large, contraceptive ef®cacy (Anawalt and Amory, 2001; Anderson and Baird, 2002). trial enrolling more than 300 men conducted in China Previous multicenter ef®cacy studies of weekly intramus- using the long-acting androgen T undecanoate (TU) alone cular (IM) T enanthate have demonstrated that T-induced showed that some men did not have sperm count sup- azoospermia is an effective contraceptive; however, some pression to azoospermia or severe oligozoospermia (Gu men on T-alone regimens do not suppress spermatogen- et al, 2003). Some men who had initially suppressed to esis to levels low enough to make pregnancy unlikely azoospermia exhibited ``sperm rebound,'' and for one of (World Health Organization, 1990, 1996). In these trials, these men and his partner, a pregnancy occurred. In pop- Asian men demonstrated higher attainments of azoosper- ulations of white men, the addition of progestins to T- mia than their non-Asian counterparts. This led to the based contraceptive regimens improves rates of azoo- hypothesis that T-alone regimens might prove effective spermia compared with T-alone regimens (Bebb et al, 1996; Handelsman et al, 1996; Meriggiola et al, 1996, Supported in part by a grant from the CICCR Program of the Contra- 1998; Anawalt et al, 1999, 2000; Kamischke et al, 2000, ceptive Research and Development (CONRAD) Program, Eastern Vir- 2001; Kinninburgh et al, 2001; Gonzalo et al, 2002), but ginia Medical School, USA, Subproject (CIG-99-37). this approach has not been tested extensively in Chinese Correspondence to: Dr He Chang-hai, Shanghai Institute of Planned men. Since sperm counts in Chinese men appear to be Parenthood Research, 2140 Xie Tu Rd, Shanghai 200032, China. Received for publication December 20, 2003; accepted for publication more easily suppressed by hormonal regimens, we hy- March 15, 2004. pothesized that a combination of TU with an implant con- 720 Gui et al ´ Male Contraception: TU and LNG Implants 721 taining the progestin levonorgestrel (LNG) would en- required to achieve azoospermia. At the end of week 28, the hance sperm suppression in Chinese men and result in a LNG implants were removed. Subjects in group III received contraceptive regimen suitable for large-scale testing and 1000 mg of TU by IM injection beginning at week 0 and every use. 8 weeks thereafter for 24 weeks. All injections were given by This study had 2 goals: ®rst, we sought to determine the study nurse in either a single injection of 4 mL (500-mg group) or two 4-mL injections (1000-mg groups) in the gluteus whether delaying the administration of the androgen after muscles; no subject missed an injection. After the completion of exposure to the progestin implant would signi®cantly im- the treatment period, the subjects were followed until serum T, prove suppression of spermatogenesis, and second, we FSH, and LH had recovered to pretreatment levels and until sought to determine if additive suppression of spermato- sperm counts were greater than 20 million per milliliter on 2 genesis mediated by the progestin implant could be main- consecutive occasions. tained with a lower androgen dose. Therefore, we con- Throughout the study, subjects were asked to provide semen ducted a prospective 3-arm trial of injections of TU alone samples every 2 weeks by masturbation after 2±7 days of sexual and with the progestin LNG administered by means of an abstinence and to undergo a monthly physical examination. implant shown previously to suppress sperm counts in Blood samples for analysis of serum levels of T, LH, and FSH normal men (Gao et al, 1999; He et al, 2001) to determine were drawn every 2 weeks throughout the study immediately the safety, reversibility, and spermatogenic suppression of prior to the injection of TU. Serum LNG levels were measured every 2 weeks in groups I and II during the study period. Blood this combination in normal Chinese men. counts, blood chemistries, and a fasting lipid panel were mea- sured at the beginning of the study, every 8 weeks during treat- ment period, and at the end of the recovery period. All serum Materials and Methods samples were centrifuged and stored at 2708C until analysis. Subjects were questioned monthly by one of the investigators Subjects about their general well-being, and any changes were noted in Sixty-two healthy Chinese men, aged 22±35 years, were enrolled the study chart. Libido and sexual function were assessed by a in this study. Inclusion criteria were as follows: a normal medical simple questionnaire used previously by our group (Gao et al, history and physical examination; normal serum levels of lu- 1999). teinizing hormone (LH), follicle-stimulating hormone (FSH), Since limited data were available on the use of TU at 8-week and T; sperm counts of greater than 20 million per milliliter with intervals, it was estimated that the rate of azoospermia in the normal values for motility and morphology on semen analyses; TU-alone group would be 60% and that the rate of azoospermia and normal values on routine hematology, blood chemistry, and in the combination groups would be 90%. Therefore, a sample fasting lipid pro®le. Individuals having a history of chronic med- size of 20 per group was calculated to have a 70% power to ®nd ical illness, taking chronic medications or anabolic steroids, or a 30% difference in the proportion of subjects achieving azoo- experiencing current or prior drug or alcohol abuse were ex- spermia between these groups at a a value (1-sided) of .05. cluded from the study. The Ethical Review Committee of the Shanghai Institute of Planned Parenthood Research approved the Measurements study, and all subjects gave written informed prior to participa- Semen analyses were performed according to World Health Or- tion. ganization (1992) guidelines. Suppression to azoospermia was de®ned as the absence of sperm from the seminal ¯uid, even TU and LNG Implants after centrifugation, in 2 or more consecutive specimens. Sperm The LNG implants each contained 75 mg of LNG (Shanghai Da rebound was de®ned as a recurrence of sperm in the ejaculate Hua Pharmaceutical Co, Shanghai, China) and are designed to after the subject had achieved azoospermia. Severe oligozoo- release between 50 and 100 mg of LNG daily. The injectable TU spermia was de®ned as 2 or more counts of between 0 and 3 was suspended in tea-seed oil at a concentration of 125 mg/mL million sperm per milliliter. Plasma FSH, LH, and T levels were (Xian Ju Pharmaceutical Co, Zhe Jiang, China). The same batch measured by immunoenzymetric assay (Serozyme, Rome, Italy).
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