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J Clin Endocrinol Metab. 2009 Jun;94(6):1910-5. doi: 10.1210/jc.2008-1846. Epub 2009 Mar 17.

Multicenter contraceptive efficacy trial of injectable testosterone undecanoate in Chinese men.

Author information

1
Department of Male Clinic Research, National Research Institute for Family Planning, 12 Da Hui Si Road, Haidian District, Beijing 100081, China. ygu90@yahoo.cn

Abstract

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 (< or =1 x 10(6)/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.

Comment in

PMID:
19293262
DOI:
10.1210/jc.2008-1846
[Indexed for MEDLINE]

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