Sex Differences & Progesterone: Association With Impulsivity and Smoking Cessation
Subjects will be stratified by sex and then randomly assigned to active progesterone (PRO)
or placebo (PBO).
Telephone screening and visit invitation leads to the consent process and in-person
screening including medical-psychiatric evaluation for inclusion/exclusion, then
randomization and medication induction, stable medication with medication reduction and
final evaluation for secondary outcomes.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Comparison of Subjects Who Relapsed - Male and Female
Our primary outcome is the binary indicator of relapsed yes/no at the week 4 visit. An unadjusted assessment of the treatment effect will come from a logistic regression of this binary outcome on randomized treatment assignment, separately by sex. All persons randomized and with a measured primary outcome at the week 4 visit will be included in this analysis, regardless of whether or not they ever took any of their assigned treatment (intent-to-treat analysis).
Sharon S. Allen, M.D.
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Delaware Clinical Research Unit, University of Minnesota||Minneapolis, Minnesota 55455|