Document Detail


A phase 2a multicenter, double-blind, placebo-controlled, crossover trial to investigate the efficacy, safety, and toleration of CP-866,087 (a high-affinity mu-opioid receptor antagonist) in premenopausal women diagnosed with female sexual arousal disorder (FSAD).
MedLine Citation:
PMID:  23347610     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
INTRODUCTION: Female sexual arousal disorder (FSAD) is a condition that can affect women of all ages and have a significant negative impact on emotional well-being.
AIMS: The aim of this study is to prospectively evaluate the effects of CP-866,087, a selective mu-opioid receptor antagonist, in premenopausal women with FSAD.
METHODS: The study included 51 women (20-45 years of age) with FSAD. All women received placebo and two of three planned doses of CP-866,087 (1, 3, and 10 mg) for 6 weeks in each of three double-blind treatment periods. Efficacy was determined through a series of measures to assess sexual functioning, sexual activity, sexual distress, and perceived meaningful benefit as a result of treatment. In addition, a semi-structured exit interview was conducted at the end of the fourth treatment period or withdrawal to provide a more in-depth, qualitative description of the participants' symptoms, response to treatment, and treatment satisfaction to augment the quantitative assessments.
MAIN OUTCOME MEASURES: The within-subject differences from placebo in the change from baseline were compared across a range of measures of sexual function. Summary statistics and 90% confidence intervals were calculated. A qualitative analysis of the exit interview was conducted based on grounded theory methods.
RESULTS: Although improvements were seen with CP-866,087 in the key efficacy end points, there was no clinical treatment benefit over placebo. The exit interview analysis suggested that being part of the study and taking positive action to search for a solution to the women's sexual disorder may have been a significant factor in the behavioral changes that were seen, as opposed to the drug treatment itself.
CONCLUSIONS: Discerning the potential benefit of pharmacotherapy in a heterogeneous condition such as FSAD is challenging. Participation in a clinical trial combined with a commitment to actively engage in sexual activity may in itself create an environment that is conducive to symptom improvement.
Authors:
Miguel Orri; Lucy Abraham; Annamaria Giraldi
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2013-01-24
Journal Detail:
Title:  The journal of sexual medicine     Volume:  10     ISSN:  1743-6109     ISO Abbreviation:  J Sex Med     Publication Date:  2013 Oct 
Date Detail:
Created Date:  2013-10-11     Completed Date:  2014-04-24     Revised Date:  2014-07-29    
Medline Journal Info:
Nlm Unique ID:  101230693     Medline TA:  J Sex Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2484-96     Citation Subset:  IM    
Copyright Information:
© 2013 International Society for Sexual Medicine.
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MeSH Terms
Descriptor/Qualifier:
Adult
Arousal / drug effects*
Australia
Cross-Over Studies
Dose-Response Relationship, Drug
Double-Blind Method
Europe
Female
Humans
Interviews as Topic
Middle Aged
Narcotic Antagonists / adverse effects,  therapeutic use*
Patient Satisfaction
Prospective Studies
Questionnaires
Receptors, Opioid, mu / antagonists & inhibitors*,  metabolism
Sexual Behavior / drug effects*
Sexual Dysfunction, Physiological / diagnosis,  drug therapy*,  metabolism,  physiopathology,  psychology
Sexual Dysfunctions, Psychological / diagnosis,  drug therapy*,  metabolism,  physiopathology,  psychology
South Africa
Time Factors
Treatment Outcome
Young Adult
Chemical
Reg. No./Substance:
0/Narcotic Antagonists; 0/Receptors, Opioid, mu

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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