Female Sexual Arousal Disorder — Alprostadil (FemLife Gel) in the Treatment of Female Sexual Arousal Disorder
Citation(s)
1 Basson R. Clinical practice. Sexual desire and arousal disorders in women. N Engl J Med. 2006;354:1497-506. 2. Addis IB et al. Reproductive Risk Factors for Incontinence Study at Kaiser Study Group. Sexual activity and function in middle-aged and older women. Obstet Gynecol. 2006;107:755-64. 3. Heiman JR et al. Topical alprostadil (PGE1) for the treatment of female sexual arousal disorder: in-clinic evaluation of safety and efficacy. J Psychosom Obstet Gynaecol. 2006;27:31-41 4. Kielbasa LA et al. Topical Alprostadil Treatment of Female Sexual Arousal Disorder Ann Pharmacother. 2006 Jun 6; [Epub ahead of print]. 5. Padma-Nathan H et al. Efficacy and Safety of Topical Alprostadil Cream for the Treatment of Female Sexual Arousal Disorder: A Double-Blind, Multicenter, Randomized, and Placebo-Controlled Clinical Trial. J of Sex and Marital Therapy. 29: 329-344, 2003.
Safety and Efficacy of Alprostadil (FemLife Gel) in the Treatment of Female Sexual Arousal Disorder
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.
