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

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.

• Authors: Yiqun Gu, Xiaowei Liang, Weixiong Wu, Minli Liu, Shuxiu Song, Lifa Cheng, Liwei Bo, Chengliang Xiong, Xinghai Wang, Xiaozhang Liu, Lin Peng, Kangshou Yao
• Journal: The Journal of clinical endocrinology and metabolism (J Clin Endocrinol Metab) Vol. 94 Issue 6 Pg. 1910-5 (Jun 2009) ISSN: 1945-7197 [Electronic] United States
• PMID: 19293262 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Contraceptive Agents, Male
• Testosterone
• testosterone undecanoate

Topics

• Adolescent
• Adult
• Algorithms
• China
• Contraception (adverse effects, methods)
• Contraceptive Agents, Male (administration & dosage, adverse effects)
• Feasibility Studies
• Female
• Humans
• Injections, Intramuscular
• Male
• Middle Aged
• Patient Compliance
• Sperm Count
• Testosterone (administration & dosage, adverse effects, analogs & derivatives)
• Treatment Outcome
• Young Adult