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Trial record 1 of 1 for:    NCT00482664
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The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women With Female Sexual Arousal Disorder.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00482664
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : November 1, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE June 1, 2007
First Posted Date  ICMJE June 5, 2007
Last Update Posted Date November 1, 2010
Study Start Date  ICMJE July 2007
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2008)
  • Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks. [ Time Frame: 6 weeks ]
  • Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment. [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2007)
Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment. Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks.
Change History Complete list of historical versions of study NCT00482664 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2008)
  • Exit interview at end of study. Meaningful Benefit Question at end of study. [ Time Frame: End of study ]
  • Measure of Female Sexual Distress questionnaire after 6 weeks of treatment. [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2007)
  • Measure of Female Sexual Distress questionnaire after 6 weeks of treatment.
  • Exit interview at end of study. Meaningful Benefit Question at end of study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women With Female Sexual Arousal Disorder.
Official Title  ICMJE A Phase 2a Multi-Centre, Double Blind, Placebo Controlled Cross-Over Trial To Investigate The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women Diagnosed With Female Sexual Arousal Disorder (FSAD).
Brief Summary CP-866,087 is a non-hormonal compound, acting on the central nervous system, which has been shown in animal models to restore sexual function.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sexual Dysfunction, Physiological
Intervention  ICMJE
  • Drug: CP-866,087
    Tablets for oral administration
  • Drug: Placebo
    Tablets for oral administration
Study Arms  ICMJE
  • Experimental: 1 mg
    Intervention: Drug: CP-866,087
  • Experimental: 10 mg
    Intervention: Drug: CP-866,087
  • Experimental: 3 mg
    Intervention: Drug: CP-866,087
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 1, 2007)
84
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy pre-menopausal women
  • primary female sexual arousal disorder causing distress
  • on stable use of oral contraceptives

Exclusion Criteria:

  • any other significant disease causing Female Sexual Dysfunction including psychiatric disease
  • subjects on drugs known to cause Female Sexual Dysfunction
  • subjects who have given birth in the last 12 months or who are planning to become pregnant during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Denmark,   Norway,   South Africa,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00482664
Other Study ID Numbers  ICMJE A5051017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP