Patrick DL, Giuliano F, Ho KF, Gagnon DD, McNulty P, Rothman M The Premature Ejaculation Profile: validation of self-reported outcome measures for research and practice. BJU Int. 2009 Feb;103(3):358-64. doi: 10.1111/j.1464-410X.2008.08041.x. Epub 2008 Sep 12.
Shafik A The mechanism of ejaculation: the glans-vasal and urethromuscular reflexes. Arch Androl. 1998 Sep-Oct;41(2):71-8.
Tang WS, Khoo EM Prevalence and correlates of premature ejaculation in a primary care setting: a preliminary cross-sectional study. J Sex Med. 2011 Jul;8(7):2071-8. doi: 10.1111/j.1743-6109.2011.02280.x. Epub 2011 Apr 14.
Evaluation of the Safety and Effectiveness of the vPatch Device for the Management and Treatment of Premature Ejaculation
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
