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Multicenter Contraceptive Efficacy Trial of Injectable Testosterone Undecanoate in Chinese Men

National Research Institute for Family Planning (Y.G., X.L.), Beijing 100081, China; Guangzhou Institute for Population and Family Planning (W.W.), Guangzhou 510630, China; Guizhou Institute for Population and Family Planning (M.L.), Guiyang 550004, China; Hebei Research Institute for Family Planning (S.S.), Shijiazhuang 050071, China; Henan Research Institute for Population and Family Planning (L.C., L.B.), Zhengzhou 450002, China; Family Planning Research Institute (C.X.), Tongji Medical College, Wuhan 430030, China; Jiangsu Family Planning Research Institute (X.W.), Nanjing 210036, China; Sichuan Family Planning Research Institute (X.L.), Chengdu 610041, China; Yunnan Family Planning Research Institute (L.P.), Kunming 650021, China; and Zhejiang Institute of Planned Parenthood (K.Y.), Hangzhou 310012, China

Address all correspondence and requests for reprints to: Yiqun Gu, M.D., Professor, Department of Male Clinic Research, National Research Institute for Family Planning, 12 Da Hui Si Road, Haidian District, Beijing 100081, China. E-mail: ygu90{at}yahoo.cn.

Context: Hormonal male contraceptive regimens effectively and reversibly suppress sperm production, but there are few large-scale efficacy studies.

Objective: The safety, contraceptive efficacy, reversibility, and feasibility of injectable testosterone undecanoate (TU) in tea seed oil as a hormonal male contraceptive was assessed.

Design: This was a multicenter, phase III, contraceptive efficacy clinical trial.

Participants: A total of 1045 healthy fertile Chinese men were recruited throughout China into the study.

Intervention(s): Injections of 500 mg TU were administered monthly for 30 months. A definition of severe oligozoospermia (1 x 10⁶/ml) was used as a criterion of spermatogenic suppression and as the threshold for entering the contraceptive efficacy phase.

Main Outcome Measure(s): The primary outcome was pregnancy rate in the partner. Other outcomes include: semen parameters, testis volumes, reproductive hormone levels, and safety laboratory tests.

Results: Forty-three participants (4.8%) did not achieve azoospermia or severe oligozoospermia within the 6-month suppression phase. A total of 855 participants entered into the efficacy phase, and 733 participants completed monthly TU treatment and follow-up. There were nine pregnancies in 1554.1 person-years of exposure in the 24-month efficacy phase for a cumulative contraceptive failure rate of 1.1 per 100 men. The combined method failure rate was 6.1%, comprising 4.8% with inadequate suppression and 1.3% with postsuppression sperm rebound. No serious adverse events were reported. Spermatogenesis returned to the normal fertile reference range in all but two participants.

Conclusions: Monthly injection of 500 mg TU provides safe, effective, reversible, and reliable contraception in a high proportion of healthy fertile Chinese men.

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