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.
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: B D Anawalt; M Y Roth; J Ceponis; V Surampudi; J K Amory; R S Swerdloff; P Y Liu; C Dart; W J Bremner; R Sitruk-Ware; N Kumar; D L Blithe; S T Page; C Wang Journal: Andrology Date: 2019-04-10 Impact factor: 3.842
Authors: M Y Roth; N Ilani; C Wang; S T Page; W J Bremner; R S Swerdloff; C Dart; R Sitruk-Ware; N Kumar; D Blithe; J K Amory Journal: Andrology Date: 2013-09-30 Impact factor: 3.842