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Sponsors and Collaborators: |
University of New Mexico Pfizer |
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Information provided by: | University of New Mexico |
ClinicalTrials.gov Identifier: | NCT00375297 |
This prospective double-blind, placebo-controlled (DBPC) study, assessed the efficacy of sildenafil in women with serotonin reuptake inhibitor antidepressant-associated sexual dysfunction (SRI-AASD) following the same protocol which previously established efficacy in men with SRI-AASD.
Condition | Intervention | Phase |
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Sexual Dysfunction Depression |
Drug: sildenafil |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Double Blind Placebo Controlled Study of Sildenafil for Treatment of Serotonergic Reuptake Inhibitor Associated Sexual Dysfunction in Women With Major Depression Treated to Remission |
Estimated Enrollment: | 100 |
Study Start Date: | January 2001 |
Estimated Study Completion Date: | June 2005 |
This prospective double-blind, placebo-controlled (DBPC) study, assessed the efficacy of sildenafil in women with serotonin reuptake inhibitor antidepressant-associated sexual dysfunction (SRI-AASD) following the same protocol which previously established efficacy in men with SRI-AASD. Women (n=100) with MDD-remission and SRI-AASD were randomized to receive sildenafil (50-100mg) or placebo for 8 weeks, followed by 8-weeks open-label extension. Sexual function was assessed using the Clinical Global Impression-Sexual Function (CGI-SF), with positive response defined as a score <3, and UNM-SFI, ASEX, SFQ-FSD sexual function questionnaires. Depression was monitored using the HAM-D17. Hypothalamic-pituitary-adrenal-gonadal hormones were measured at baseline and DB-endpoint.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:S Subjects will be females only, ages 18 to 50 years.
Subjects must meet at least one of the following criteria:
Clinically significant orgasm delay with masturbation or intercourse that according to patient opinion:
Exclusion Criteria:
United States, New Mexico | |
University of New Mexico Health Sciences Center | |
Albuquerque, New Mexico, United States, 87131 |
Principal Investigator: | George Nurnberg, MD | University of New Mexico School of Medicine |
Study ID Numbers: | 99321, Acc# 4-37011 |
Study First Received: | September 11, 2005 |
Last Updated: | September 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00375297 History of Changes |
Health Authority: | United States: Food and Drug Administration |
antidepressants sexual dysfunction women sildenafil |
PDE5 inhibitors serotonin reuptake inhibitor antidepressants women sildenafil |
Neurotransmitter Agents Vasodilator Agents Depression Psychotropic Drugs Sildenafil Cardiovascular Agents Depressive Disorder, Major Depressive Disorder |
Serotonin Uptake Inhibitors Serotonin Behavioral Symptoms Phosphodiesterase Inhibitors Mental Disorders Mood Disorders Antidepressive Agents |
Vasodilator Agents Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Depression Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Enzyme Inhibitors Sildenafil Cardiovascular Agents Depressive Disorder |
Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms Phosphodiesterase Inhibitors Serotonin Agents Mental Disorders Therapeutic Uses Mood Disorders Central Nervous System Agents Antidepressive Agents |