CCTN - MALE CONTRACEPTIVE TRIAL DMAU-SEDDS STUDY

点击翻译按钮获取中文摘要

To conduct Phase I clinical trials of single doses of a new drug entity, Dimethandrolone undecanoate. This Task Order is for the conduct of a Phase I clinical trial to test whether Dimethandrolone undecanoate will be well tolerated and will suppress gonadotropins. Preliminary results from animal studies indicate that an oral or an intramuscular dose of the drug has both progestin and androgen activity and will suppress gonadotropins sufficiently to a level that produces inhibition of spermatogenesis. Delivery of the dose intramuscularly may have long acting effectiveness. Since this study is first in man IM delivery, it is not known what dose of drug will be effective at suppression of gonadotropins or if the drug will be well tolerated. The study will test a single dose of drug in men and will continue with single doses of escalating strength assuming that the drug is well tolerated. The primary outcome will be to measure suppression of gonadotropins over the treatment period and to collect information about possible side effects. The objective of the trial is to determine, in a Phase I clinical trial, whether intramuscular doses of a new chemical entity, Dimethandrolone undecanoate, will be well tolerated in a single dose escalation study. Results from the Phase I trial will establish if the agents could be evaluated in a longer-term sperm suppression clinical trial, pursuant to obtaining FDA approval as a contraceptive. Therefore, the objective of this Task Order is to conduct the study so that the overall objectives of the Phase I clinical trial are successfully achieved.