Emily Dorman; David Bishai

Disclosures

Expert Rev Pharmacoeconomics Outcomes Res. 2012;12(5):605-613. 

In This Article

Acceptability of Male Methods: Clinical Trial Data

Male and female acceptance of novel formulations have been measured through interviews and surveys of participants in clinical trials. In the WHO trials, where weekly injections were administered, 85% of participants said they would prefer the trial method to the method they had been using before the trial if the injection were offered at 3-month intervals. Three quarters of the women in the study said they would have continued the trial method if allowed.[28] In a study of Italian men receiving regular injections (at 6, 8 or 12 weeks), 61% of men said the method in the study was 'excellent' or 'good'.[29] Slightly less positive results were found in a study of American men treated with a 3-monthly injection of depomedroxyprogesterone and daily testosterone transdermal gel. Half of those who completed the trial reported being satisfied; 45% said they would use it in future and 40% found it preferable to the method they had been using before the study.[30]

Aggregate analysis of acceptability from clinical trials indicates that discomfort at the injection site and injection schedules account for 35–40% of dissatisfaction with injection methods.[31,32] Similarly, a third of users of topical gels indicated daily application of the gel negatively interrupted their daily routine .[30]

Acceptability of data from clinical trials improve upon hypothetical surveys in that they are based on real experience with male contraception. However, men who participate in clinical trials of contraceptives are not representative of the general population. Even with these caveats, these data provide strong evidence of acceptability and even some preference for male injectable methods.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....